North America In Vitro Diagnostics Market Outlook to 2018 ... · 7.7 Genetic Testing Market Pipeline Products 149. 8 Financial Deals Landscape 154. 8.1 Acquisition 154. 8.1.1 SQI

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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,

Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 1

North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture

Reference Code: GDME0193RDB

Publication Date: December 2012

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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 33

1.2 List of Figures 42

2 Introduction 43

2.1 What is This Report About? 43

3 In Vitro Diagnostics in North America 44

3.1 In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018 44

3.2 In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018 45

3.3 In Vitro Diagnostics, North America, Company share (2010-2011) 53

4 In Vitro Diagnostics In United States 55

4.1 In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 55

4.2 In Vitro Diagnostics, United States, Distribution Share (2010-2011) 61

4.2.1 Clinical Chemistry Distribution Share (2010-2011) 61

4.2.2 Genetic Testing Distribution Share (2010-2011) 61

4.2.3 Haematology Distribution Share (2010-2011) 62

4.2.4 Histology And Cytology Distribution Share (2010-2011) 62

4.2.5 Immuno Chemistry Distribution Share (2010-2011) 63

4.2.6 Infectious Immunology Distribution Share (2010-2011) 63

4.2.7 Microbiology Culture Distribution Share (2010-2011) 64

4.3 In Vitro Diagnostics, United States, Company Share (2010-2011) 65

4.3.1 Clinical Chemistry, United States, Company Share (2010-2011) 67

4.3.2 Genetic Testing, United States, Company Share (2010-2011) 68

4.3.3 Haematology, United States, Company Share (2010-2011) 70

4.3.4 Immuno Chemistry, United States, Company Share (2010-2011) 72

4.3.5 Infectious Immunology, United States, Company Share (2010-2011) 74

4.3.6 Microbiology Culture, United States, Company Share (2010-2011) 76

5 In Vitro Diagnostics In Canada 78

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5.1 In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, 2004-2018 78

5.2 In Vitro Diagnostics, Canada, Distribution Share (2010-2011) 84

5.3 Clinical Chemistry Distribution Share (2010-2011) 84

5.3.1 Genetic Testing Distribution Share (2010-2011) 84

5.3.2 Haematology Distribution Share (2010-2011) 85

5.3.3 Histology And Cytology Distribution Share (2010-2011) 85

5.3.4 Immuno Chemistry Distribution Share (2010-2011) 86

5.3.5 Infectious Immunology Distribution Share (2010-2011) 86

5.3.6 Microbiology Culture Distribution Share (2010-2011) 87

5.4 In Vitro Diagnostics, Canada, Company Share (2010-2011) 88

5.4.1 Clinical Chemistry, Canada, Company Share (2010-2011) 90

5.4.2 Genetic Testing, Canada, Company Share (2010-2011) 92

5.4.3 Haematology, Canada, Company Share (2010-2011) 94

5.4.4 Histology And Cytology, Canada, Company Share (2010-2011) 96

5.4.5 Immuno Chemistry, Canada, Company Share (2010-2011) 98

5.4.6 Infectious Immunology, Canada, Company Share (2010-2011) 100

5.5 Microbiology Culture, Canada, Company Share (2010-2011) 102

6 Overview of Key Companies in North America In Vitro Diagnostics 104

6.1 Siemens Healthcare 104

6.1.1 Company Overview 104

6.1.2 Share in the North America In Vitro Diagnostics Market 104

6.2 Abbott Laboratories 105



6.3 F. Hoffmann-La Roche Ltd. 106



6.4 Beckman Coulter, Inc. 107



6.5 Ortho-Clinical Diagnostics Inc. 108



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6.6 Alere Inc. 109



6.7 bioMerieux S.A. 110


6.8 Becton, Dickinson and Company 110


6.9 Bio-Rad Laboratories, Inc. 111


6.10 Sysmex Corporation 111


6.11 Qiagen N.V. 112


6.12 Gen-Probe Incorporated 112


6.13 DiaSorin S.p.A 113


6.14 Immucor, Inc. 113


6.15 Thermo Fisher Scientific Inc. 114


6.16 Hologic, Inc. 114


6.17 Cepheid 115


6.18 PerkinElmer, Inc. 115


6.19 Grifols, S.A. 116


6.20 ELITech Group 116


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6.21 Life Technologies Corporation 117


6.22 Horiba, Ltd. 117


6.23 Biomedica Diagnostics Inc. 118


6.24 Diagnostica Stago, Inc. 118


6.25 OraSure Technologies, Inc. 118


7 North America Market Pipeline Products 119

7.1 Clinical Chemisty Market Pipeline Products 119

7.2 Immuno Chemistry Market Pipeline Products 126

7.3 Haematology Market Pipeline Products 137

7.4 Infectious Immunology Market Pipeline Products 139

7.5 Microbiology Culture Market Pipeline Products 146

7.6 Histology And Cytology Market Pipeline Products 148

7.7 Genetic Testing Market Pipeline Products 149

8 Financial Deals Landscape 154

8.1 Acquisition 154

8.1.1 SQI Diagnostics Plans For Sale Of The Company 154

8.1.2 Sparton Completes Acquisition Of Onyx EMS, Contract Manufacturing Services Provider, For $43

Million 155

8.1.3 ERBA Diagnostics Acquires Drew Scientific, Maker Of Analytical Instruments And Reagents, For

$6.5 Million 157

8.1.4 Measurement Specialties Acquires Cambridge Technologies And Resistance Temperature

Detector Company For $18.8 Million 159

8.1.5 Atossa Genetics Acquires Acueity Healthcare, Diagnostic Device Provider 160

8.1.6 AccelPath Acquires DigiPath Solutions For $2.4 Million 161

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8.1.7 Danaher Completes Acquisition Of 91.6% Stake In Iris International, Diagnostic Test Maker, For

$324 Million 162

8.1.8 Charles River Labs Acquires Accugenix, Provider Of Microbe Identification Services, For $17

Million 164

8.1.9 Leica Biosystems Completes Acquisition Of Aperio Technologies 166

8.1.10 Metabolon Acquires Lipomics Technologies, Diagnostics Company 169

8.1.11 Waters Acquires Blue Reference, Maker Of Application Scientific Databases, For $14 Million 171

8.1.12 Life Technologies Acquires Pinpoint Genomics, Molecular Diagnostics Company 172

8.1.13 Thermo Fisher Scientific Completes Acquisition Of One Lambda, Transplant Diagnostics

Company, For $925 Million 173

8.1.14 Life Technologies Acquires Navigenics 175

8.1.15 Genova Diagnostics Acquires Metametrix, Clinical Laboratory 177

8.1.16 23andMe Acquires CureTogether, Healthcare IT Company 178

8.1.17 Luminex To Acquire GenturaDx, Molecular Diagnostics Company, For $50 Million 179

8.1.18 Systagenix Acquires O2 Insights 181

8.1.19 Maxxam Analytics Acquires Becquerel Labs, Provider Of Testing Services 182

8.1.20 LabCorp Completes Acquisition Of Medtox Scientific For $241 Million 183

8.1.21 Flagship Biosciences Acquires Ihctech, Provider Of Research Immunohistochemistry And

Histology Services 185

8.1.22 Halo Healthcare Acquires NeoMatrix, Maker Of Diagnostic Equipments 186

8.1.23 Pacepartners To Acquire Vivione BioSciences 187

8.1.24 Qiagen Acquires AmniSure International, Manufacturer Of Non Invasive Test Solutions 188

8.1.25 Hologic Completes Acquisition Of Gen-Probe For $3.7 Billion 189

8.1.26 Haemonetics To Acquire Hemerus Medical, Provider Of Leukoreduction Technologies, For $27

Million 192

8.1.27 IntegenX Acquires SV, Provider Of DNA Identification Consumable Products, From GE

Healthcare Bio-Sciences 194

8.1.28 Beckman Coulter Acquires Blue Ocean Biomedical From Npe Systems 195

8.1.29 Abcam Completes Acquisition Of Epitomics, Rabbit Monoclonal Antibodies Provider, For $155

Million 196

8.1.30 Ontario Genomics Institute Acquires Minority Stake In RNA Diagnostics For $0.1 Million 198

8.1.31 PhotoVoltaic Solar Cells Acquires MetaStat, Life Science Company 199

8.1.32 Alere To Acquire eScreen, Provider Of Health Testing Products And Services, For Up To $340

Million 200

8.1.33 Bode Technology Group Acquires Provider Of DNA Analysis Testing Services, Chromosomal

Labs 202

8.1.34 Signal Genetics To Acquire Molecular Diagnostics Company, ChipDX 203

8.2 Partnerships 204

8.2.1 Multiple Myeloma Research Foundation Enters Into Co-Development Agreement With

GenoSpace 204

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8.2.2 Empire Genomics Enters Into Licensing Agreement With Emory University For Genomic

Biomarkers 205

8.2.3 NanoPass Technologies Enters Into Licensing Agreement With Janssen Pharma For MicronJet

206

8.2.4 Cisbio Bioassays Enters Into Distribution Agreement With BellBrook Labs For Transcreener

Epigen Methyltransferase Assay 207

8.2.5 BioView Enters Into Agreement With Abbott To Develop Automated Cancer Screening System

209

8.2.6 Institute of Microelectronics Enters Into Co-Development Agreement With SFC Fluidics 210

8.2.7 HTG Molecular Diagnostics Enters Into Licensing Agreement With Centre of Excellence for

Prevention of Organ Failure For COPD Prognostic Test 211

8.2.8 Pressure BioSciences Enters Into Co-Marketing Agreement With Constant Systems For High

Pressure Technologies 212

8.2.9 CML HealthCare Enters Into Licensing Agreement With Mitomics For Prostate Cancer Test 214

8.2.10 bioMerieux Enters Into Licensing Agreement With Quanterix For Simoa Technology 215

8.2.11 DioGenix Enters Into Agreement With Fast Forward To Develop New Blood Test For Multiple

Sclerosis 217

8.2.12 GNS Healthcare Enters Into Agreement With Dana-Farber Cancer Institute and Mount Sinai

School of Medicine 219

8.2.13 Crown Bioscience Enters Into Co-Development Agreement With Horizon Discovery 221

8.2.14 CombiMatrix Enters Into Co-Marketing Agreement With Pathology For Prenatal Tests 222

8.2.15 Clinical Genomics Enters Into Licensing Agreement With Quest Diagnostics For Colon Cancer

Markers 223

8.2.16 Abaxis Enters Into Distribution Agreement With Abbott Point of Care For Piccolo Blood Chemistry

System 224

8.2.17 Affinity Biosensors Enters Into Distribution Agreement With Malvern Instruments For Archimedes

Particle Metrology System 226

8.2.18 Malvern Instruments Enters Into Co-Marketing Agreement With Affinity Biosensors For

Archimedes Particle Metrology System 227

8.2.19 Exosome Diagnostics Enters Into Co-Development Agreement With Promega For Urine Clinical

Sample Concentrator Kit 228

8.2.20 Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ 229

8.2.21 Ezose Enters Into Co-Development Agreement With Fast Forward For Multiple Sclerosis

Biomarkers 230

8.2.22 BioDot Enters Into Co-Marketing Agreement With JOT Automation 231

8.2.23 Sequella Enters Into Licensing Agreement With LabCorp For B-Smart Technology 232

8.2.24 LifeTech Scientific, DiNova Venture Partners, Themes Investment Partners And Broncus

Technologies Partner To Form Broncus Medical 233

8.2.25 Van Andel Institute Enters Into Co-Development Agreement With Emory University 235

8.2.26 Merck Serono Enters Into Co-Development Agreement With Auxogyn For Early Embryo Viability

Assessment Test 236

8.2.27 PGXL Labs Enters Into Joint Venture Agreement With Essential Molecular Testing 237

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8.2.28 Broad Institute Enters Into Distribution Agreement With Appistry For Genome Analysis Toolkit 238

8.2.29 Thermo Fisher Enters Into Co-Development Agreement With Immundiagnostik 239

8.2.30 Sage Labs Enters Into Agreement With Ekam Imaging To Develop Imaging Assays 240

8.2.31 Bruker Enters Into An Agreement With Nextval For High-throughput Screening Technology 241

8.2.32 BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays

242

8.2.33 RainDance Technologies Enters Into Co-Development Agreement With Integrated DNA

Technologies For Digital PCR 243

8.2.34 Amarantus BioSciences Enters Into Option For Licensing Agreement With Memory Dx For

LymPro Blood Test 245

8.2.35 Iverson Genetic Diagnostics Enters Into Licensing Agreement With Johns Hopkins University

School For Molecular Diagnostic Tests 246

8.2.36 Rosetta Genomics Amends Co-Marketing Agreement With Precision Therapeutics For miRview

mets2 Assays 247

8.2.37 Mitomics Enters Into Co-Marketing Agreement With LabCorp For Prostate Core Mitomic Test 248

8.2.38 Trillium Diagnostics Enters Into Licensing Agreement With Leukocare For Sepsis Dx 250

8.2.39 Foundation Medicine Enters Into Agreement With Eisai For Genomic Profiling And Diagnostic

Discovery 251

8.2.40 Vela Diagnostics Enters Into Licensing Agreement With Life Technologies 252

8.2.41 Augurex Life Sciences Enters Into Licensing Agreement With Quest Diagnostics For 14-3-3n

Biomarker 253

8.2.42 CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital Microscopy

Hematology Solutions 254

8.2.43 Ingenuity Systems Enters Into Co-Development Agreement With Life Technologies For

Diagnostic Solutions 256

8.2.44 Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx

Test 258

8.2.45 Genia Technologies Enters Into Co-Development Agreement With Columbia University And

Harvard University 260

8.2.46 NextBio Enters Into Agreement With Winship Cancer Institute of Emory University For Myeloma

Biomarkers 262

8.2.47 Proof Centre Enters Into Co-Development Agreement With AllerGen For Allergy Biomarkers 263

8.2.48 Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology 264

8.2.49 Atossa Enters Into Co-Marketing Agreement With Diagnostics Test Group For MASCT System

265

8.2.50 Genalyte Partners Scienion To Provide Sciflexarrayer Dispensers For Maverick Detection

Platform 266

8.2.51 CML HealthCare Enters Into Agreement With MaRS Innovation 267

8.2.52 Life Technologies Enters Into Agreement With Bristol-Myers Squibb For Companion Diagnostics

Development 268

8.2.53 Agilent Technologies Enters Into Co-Marketing Agreement With Molecular Discovery 269

8.2.54 Agilent Technologies Enters Into Co-Marketing Agreement With MRM Proteomics 270

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8.2.55 Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For

Mesothelioma Test 271

8.2.56 Illumina Enters Into Technology Integration Agreement With Partners HealthCare System 272

8.2.57 Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array

Products 274

8.2.58 ImaginAb Enters Into Co-Development Agreement With MacroGenics 275

8.2.59 BellBrook Labs Enters Into Co-Development Agreement With Reaction Biology 276

8.2.60 GVK Biosciences Enters Into Licensing Agreement With National Cancer Institute For GOBIOM

Database 277

8.2.61 GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina 278

8.2.62 Perkinelmer Enters Into Co-Development Agreement With Massachusetts General Hospital 279

8.2.63 Affymetrix Enters Into Co-Development Agreement With Pathgen Dx 281

8.2.64 Axela Enters Into Co-Marketing Agreement With OvaGene Oncology 282

8.2.65 University of Michigan Enters Into Joint Venture Agreement With International Genomics

Consortium 283

8.2.66 Regulus Therapeutics Enters Into An Agreement With Biogen Idec For Biomarkers 284

8.2.67 Curetis Enters Into Licensing Agreement With Cempra For Unyvero 285

8.2.68 Foundation Medicine Enters Into Co-Development Agreement With Clovis Oncology 286

8.2.69 Saladax Biomedical Expands Co-Development Agreement With Bristol-Myers Squibb 287

8.2.70 Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test

288

8.2.71 Waters Enters Into Co-Development Agreement With Nonlinear Dynamics 289

8.2.72 Affymetrix Expands Licensing Agreement With Siemens Healthcare For Branched DNA

Technology 290

8.2.73 Molecular Targeting Technologies Enters Into Licensing Agreement With Medical College of

Wisconsin For 99mTc-HYNIC-Duramycin 291

8.2.74 Rosetta Genomics Enters Into Co-Marketing Agreement With Precision Therapeutics For

miRview mets2 Assays 292

8.2.75 Bio-Rad Labs Enters Into Distribution Agreement With Myriad RBM For Multiplex Biomarker Kits

294

8.2.76 Gen-Probe Enters Into Co-Marketing Agreement With Life Technologies 295

8.2.77 OriGene Technologies Enters Into Co-Development Agreement With Centre of Excellence for

Prevention of Organ Failure 296

8.2.78 Siemens Healthcare Diagnostics Enters Into Distribution Agreement With Sysmex 297

8.2.79 IRIS International Enters Into Distribution Agreement With Alifax 298

8.2.80 EKF Diagnostics Enters Into Licensing Agreement With Joslin Diabetes Center 299

8.2.81 SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor 301

8.2.82 Clovis Oncology Enters Into Co-Development Agreement With Array BioPharma 302

8.2.83 RS Medical Enters Into Distribution Agreement With Harvest Technologies 303

8.2.84 Immuno-Biological Labs Enters Into Licensing Agreement With IBL International 304

8.2.85 Sandia National Labs Plans To Enter Into Licensing Agreement For SpinDx, Medical Diagnostic

Tool 305

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8.2.86 HTG Molecular Diagnostics Enters Into Licensing Agreement With Merck For Breast Cancer

Marker Patent Portfolio 306

8.2.87 Genisphere Enters Into Co-Development Agreement With Lankenau Institute for Medical

Research 307

8.2.88 WaferGen Biosystems Enters Into Agreement With Integrated DNA Technologies 308

8.2.89 Pacgen Enters Into Distribution Agreement With Arise Biotech For Pipettes 309

8.2.90 BioView Enters Into Co-Development Agreement With ScreenCell For Circulating Tumor Cell

Analysis Technology 310

8.2.91 MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test 311

8.2.92 Fluxion Biosciences Enters Into Co-Development Agreement With Stanford University School of

Medicine 313

8.2.93 Merrimack Pharma Enters Into Co-Development Agreement With Cancer Treatment Centers of

America 314

8.2.94 Phenomenome Discoveries Enters Into Licensing Agreement With Polymedco For Cancer

Diagnostic Test 315

8.2.95 PlexPress Enters Into Technology Integration Agreement With Phalanx Biotech 316

8.2.96 PrimeraDx Enters Into Co-Development Agreement With Eli Lilly 317

8.2.97 Kreatech Diagnostics Enters Into Co-Development Agreement With Oridis Biomarkers For DNA-

FISH Assays 319

8.2.98 Stratos Enters Into Co- Development Agreement With nanoMR 320

8.2.99 Guided Therapeutics Extends Licensing And Co-Development Agreement With Konica Minolta

321

8.2.100 CogState Enters Into Licensing Agreement With Merck Canada For Cognition Test 322

8.2.101 Berg Pharma Enters Into Co-Development Agreement With Parkinson's Institute 323

8.2.102 Courtagen Life Sciences Enters Into Licensing Agreement With Scienion For sciFlexArrayer

Technology 324

8.2.103 NicOx Enters Into Licensing Agreement With Rapid Pathogen Screening For AdenoPlus 325

8.2.104 Leica Microsystems Enters Into Integration Agreement With Indica Labs 327

8.2.105 Prolias Technologies Enters Into Licensing Agreement With Cornell University For microRNA

Diagnostic Portfolio 328

8.2.106 Epigenomics Enters Into Licensing Agreement With Companion Dx Reference Lab For Septin9

Biomaker 329

8.2.107 Immunexpress Enters Into Licensing Agreement With Debiopharm And Biocartis 330

8.2.108 Asuragen Enters Into Licensing Agreement With Becton, Dickinson 332

8.2.109 Omega Diagnostics Enters Into Licensing Agreement With Burnet Institute For CD4 POC Test

333

8.2.110 KineMed Enters Into Co-Development Agreement With GlaxoSmithKline 334

8.2.111 Bruker Enters Into Research Agreement With Special Bacteriology Reference Laboratory 335

8.2.112 Bruker Enters Into Research Agreement With JMI Laboratories 337

8.2.113 RayBiotech Enters Into Agreement With Oslo University Hospital And University of Oslo 338

8.2.114 Vela Diagnostics Enters Into Co-Development Agreement With Eppendorf 340

8.2.115 One Lambda Enters Into Co-Marketing Agreement With CellTrend 341

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8.2.116 ImaginAb Extends Licensing Agreement With Bzl Biologics For Imaging Prostate Specific

Membrane Antigen 342

8.2.117 Foundation Medicine Extends Co-Development Agreement With Novartis 343

8.2.118 Affymetrix Enters Into Co-Development Agreement With Massachusetts General Hospital For

New Oncology Biomarker Tests 344

8.2.119 Fluxion Bioscience Enters Into Technology Integration Agreement With Rubicon Genomics 345

8.2.120 Exosome Diagnostics Enters Into Technology Integration Agreement With Life Technologies

346

8.2.121 HTG Molecular Diagnostics Enters Into Co-Marketing Agreement With John Wayne Cancer

Institute 347

8.2.122 Clarient Diagnostic Services Enters Into Licensing Agreement With Insight Genetics For ALK

Cancer Biomarker 348

8.2.123 Ventana Medical Enters Into Licensing Agreement With German Cancer Research Center And

University Hospital Heidelberg For BRAF V600E 349

8.2.124 Affymetrix Enters Into Technology Integration Agreement With Leica Microsystems 351

8.2.125 Radisens Diagnostics Enters Into Co-Development Agreement With Beckman Coulter For HDR

Detection Technology 353

8.2.126 XDx Enters Into Agreement With LabCorp To Develop Lupus Flare Predictor Test 354

8.2.127 Prosolia Enters Into Licensing Agreement With AB Sciex For ORNL Analytical Technology 356

8.2.128 Ventana Medical Enters Into Licensing Agreement With Gen-Probe For IP Of ERG Marker 357

8.2.129 Affymetrix Enters Into Distribution Agreement With ScreenCell For Circulating Tumor Cell

Technology 359

8.2.130 Exact Sciences Expands Licensing Agreement With Mayo Clinic 360

8.2.131 Hycor Biomedical Enters Into Distribution Agreement With Roche For KOVA 361

8.2.132 Dako Announces Licensing Agreement With Van Andel Research Institute For Cancer

Diagnostic Tool 362

8.2.133 MicroFluidic Systems Enters Into Co-Development Agreement With University of Nevada 363

8.2.134 KineMed Enters Into Co-Development Agreement With CHDI Foundation 364

8.2.135 ZyGem Enters Into Technology Integration Agreement With Quanta BioSciences 365

8.2.136 Pressure BioSciences Enters Into Co-Development Agreement With Leap Technologies, Vici

Valco Instruments And Sage-N Research 366

8.2.137 Islet Sciences Enters Into Licensing Agreement With Yale University For Early Beta Cell

Destruction and Diabetes Diagnostic 368

8.2.138 Genomic Health Enters Into Co-Development Agreement With OncoMed Pharma 369

8.2.139 Applied Microarrays Enters Into Co-Development Agreement With Sensovation For FlexiPlex

Array System 370

8.2.140 Cardinal Health Enters Into Distribution Agreement With Qiagen For Molecular Diagnostic

Products 371

8.2.141 MetaStat Enters Into Licensing Agreement With Albert Einstein College of Medicine For

Metastatic Cell Technology Patents 372

8.2.142 Genome Diagnostics Enters Into Co-Marketing Agreement With Qiagen For LongRange PCR

Kit 373

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8.2.143 Biofortuna Extends Co-Marketing Agreement With Abbott Labs For SSPGo 374

8.2.144 Pressure BioSciences Enters Into Licensing Agreement With Target Discovery For Pressure

Cycling Technology 375

8.2.145 Ezose Sciences Enters Into Co-Development Agreement With Hirosaki University For New

Cancer Biomarkers 377

8.2.146 LipoScience Enters Into Licensing Agreement With Cleveland Clinic 378

8.2.147 GE Healthcare Enters Into Co-Development Agreement With NXT2B For Compact Cyclotron

And PET Tracer System 379

8.2.148 Miraculins Enters Into Co-Marketing Agreement With Pear Healthcare Solutions For PreVu 380

8.2.149 Abbott Enters Into Licensing Agreement With Stanford University For Prostate Cancer

Biomarkers 381

8.2.150 Metabolon Enters Into Co-Development Agreement With Takeda Pharma 383

8.2.151 Penn State Hershey Enters Into Co-Development Agreement With Serametrix 384

8.2.152 Sysmex Extends Distribution Agreement With Roche 385

8.2.153 Seattle Genetics And Millennium Pharma Enter Into Co-Development Agreement With Ventana

Medical Systems 387

8.2.154 Rubicon Genomics Enters Into Technology Integration Agreement With Kreatech Diagnostics

389

8.2.155 NexDx Enters Into Licensing Agreement With University of California For Epigenetic

Biomarkers 390

8.2.156 Elchrom Scientific Enters Into Technology Integration Agreement With Biotium 391

8.2.157 RayBiotech Enters Into Co-Marketing Agreement With Innopsys 392

8.2.158 BGN Technologies Enters Into Licensing Agreement With Lauren Sciences For V-Smart

Technology 393

8.2.159 Stellar Biotechnologies Enters Into Option Licensing Agreement With University of Guelph For

Clostridium Difficile Technology 394

8.2.160 Shimadzu Scientific Instruments Enters Into Joint Venture Agreement With University of Texas

395

8.2.161 Centre of Excellence for Prevention of Organ Failure Enters Into Co-Development Agreement

With Adiga Life Sciences For Proteomic And Genomic Biomarkers 396

8.2.162 Ridge Diagnostics Enters Into Licensing Agreement With Ameritox For MDDScore 397

8.2.163 Bio-Rad Labs Extends Distribution Agreement With Luminex For MAGPIX 398

8.2.164 LabCorp Enters Into Licensing Agreement With OPKO Health For Alzheimer's Diagnostic

Technology 400

8.2.165 Accuray Enters Into Co-Development Agreement With University of Heidelberg 402

8.2.166 HTG Molecular Diagnostics Enters Into Co-Development Agreement With sanofi-aventis 403

8.2.167 GenMark Diagnostics Enters Into Co-Development Agreement With Advanced Liquid Logic For

Integrated Diagnostic Platform 404

8.2.168 PerkinElmer Enters Into Licensing Agreement With GenMark Diagnostics For Microfluidics

Patent Portfolio 406

8.2.169 Bristol-Myers Squibb Enters Into Co-Development Agreement With Meso Scale 408

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8.2.170 Applied BioCode Enters Into Licensing Agreement With Douglas Scientific For Barcoded

Magnetic Beads Technology 409

8.2.171 Molecular Response Enters Into Co-Marketing Agreement With Transparent 410

8.2.172 IBM Enters Into Co-Development Agreement With Memorial Sloan-Kettering Cancer Center 411

8.2.173 QuantiScientifics Enters Into Co-Marketing Agreement With BioDot For A2 MicroArray System

412

8.2.174 INOVA Diagnostics Enters Into Licensing Agreement With AmberGen And Massachusetts

General Hospital For Two Autoantigen Biomarkers 413

8.2.175 Waters Enters Into Co-Marketing Agreement With Protea Biosciences Group For LASEI DP-

1000 415

8.2.176 Devicor Medical Products Enters Into Co-Marketing Agreement With Carbon Medical

Technologies 416

8.2.177 Diomics Enters Into Licensing Agreement With University of Arizona For DNA Collection

Technology 417

8.2.178 Sage-N Research Enters Into Technology Integration Agreement With IO Informatics 418

8.2.179 Mayo Medical Labs Enters Into Licensing Agreement With A&G Pharma For Progranulin Blood

Test 419

8.2.180 Abbott Enters Into Co-Development Agreement With Genetics Lab For Molecular Assay

Development 420

8.2.181 Avedro Enters Into Option Agreement With Cleveland Clinic To License Intellectual Property

Assets 421

8.2.182 GE Global Research Enters Into Co-Development Agreement With InDevR 422

8.2.183 Roche Enters Into Licensing Agreement With Life Technologies For PCR Technology 423

8.2.184 Vital Diagnostics Enters Into Distribution Agreement With Cardinal Health 424

8.2.185 Dako Enters Into Co-Development Agreement With Amgen 425

8.2.186 Iverson Genetic Diagnostics Enters Into Co-Development Agreement With Vanderbilt

University 426

8.2.187 RedHill Biopharma Enters Into Co-Development Agreement With Quest Diagnostics To

Develop MAP Test For Crohn's Disease 427

8.2.188 Thermo Fisher Scientific Extends Licensing Agreement With Wako Pure Chemical Industries

428

8.2.189 Dolomite Centre Enters Into Co-Development Agreement With GigaGen 429

8.2.190 Mitomics Enters Into Co-Marketing Agreement With LabMD For Prostate Core Mitomic Test 430

8.2.191 Fresh Start Private Management Enters Into Licensing Agreement With Glacier 431

8.2.192 IRIS Sample Processing Enters Into Distribution Agreement With Fisher HealthCare 432

8.2.193 Courtagen Life Sciences Enters Into Co-Development Agreement With Tetracore 433

8.2.194 Quanterix, Beth Israel Deaconess And Forsyth Institute Enter Into Partnership To Develop

Tuberculosis Test 434

8.2.195 Avesthagen Enters Into Co-Development Agreement With CosmosID 436

8.2.196 Siemens Healthcare Diagnostics Enters Into Co-Development Agreement With ViiV Healthcare

437

8.2.197 Siemens Healthcare Diagnostics Enters Into Co-Development Agreement With Tocagen 439

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8.2.198 Brooks Life Science Enters Into Licensing Agreement With The Scripps Research Institute 441

8.2.199 SDIX Enters Into Licensing Agreement With BD Diagnostic 443

8.2.200 Thermo Fisher Scientific Enters Into Distribution Agreement With BellBrook Labs 444

8.2.201 DuPont Enters Into Co-Development Agreement With OligoCo 445

8.2.202 Genzyme Enters Into Co-Marketing Agreement With Veracyte 447

8.2.203 Boulder Diagnostics Enters Into Licensing Agreement With Portland State University 448

8.2.204 Ventana Medical Systems Enters Into Co-Development Agreement With Bayer Pharma 449

8.2.205 Pressure BioSciences Enters Into Co-Marketing Agreement With Digilab 451

8.2.206 Agilent Technologies Enters Into Co-Development Agreement With Integrated Diagnostics 453

8.2.207 Ventana Medical Systems Enters Into Co-Development Agreement With Pfizer 454

8.2.208 Ventana Medical Systems Enters Into Licensing Agreement With Cell Signaling Technology 456

8.2.209 Dako Enters Into Co-Development Agreement With Amgen 458

8.2.210 Foundation Medicine Enters Into Co-Development Agreement With Sanofi For Genetic

Biomarkers And Potential Diagnostics 459

8.2.211 University Of North Dakota Enters Into Licensing Agreement With NeoMatrix 460

8.2.212 Amorfix Life Sciences Enters Into Licensing Agreement With JSW-Lifesciences 461

8.2.213 Syndax Pharma Enters Into Co-Development Agreement With Ventana Medical Systems 462

8.2.214 ZyGEM Enters Into Co-Development Agreement With USAMRIID 464

8.2.215 AEterna Zentaris Enters Into Co-Development Agreement With Ventana Medical Systems 465

8.2.216 Boulder Diagnostics Enters Into Licensing Agreement With RUNMC 467

8.2.217 HistoRx Enters Into Licensing Agreement With Yale University 468

9 Recent Developments 469

9.1 Strategy And Business Planning 469

9.1.1 Nov 28, 2012: Abbott Board Approves Separation Of AbbVie 469

9.1.2 Nov 27, 2012: Abbott Labs To Revamp India Operations 469

9.1.3 Nov 20, 2012: PerkinElmer Establishes New Direct Operations In Southern Africa 470

9.1.4 Nov 13, 2012: BG Medicine Provides Business Update 470

9.1.5 Nov 07, 2012: Namsa Expands Laboratory In Lyon, France 471

9.1.6 Nov 05, 2012: Flambeau Medical Markets Group Expands New Facility 472

9.1.7 Oct 16, 2012: Alliance HealthCare Services Announces Oncology Therapy Facilities Expansion

472

9.1.8 Oct 11, 2012: Quest Diagnostics To Cut 400-600 Management Jobs; Creates Two New Business

Structures 473

9.1.9 Oct 08, 2012: DSM Pharma And Almac Sign Collaboration Agreement In Biocatalysis 474

9.1.10 Oct 02, 2012: AIBioTech Expands Bioorganic Chemistry Platform 474

9.1.11 Sep 28, 2012: Sigma-Aldrich Invests In Scotland 475

9.1.12 Sep 19, 2012: Fidelis Diagnostics Opens New Office In Denver, Colorado 475

9.1.13 Sep 18, 2012: CML HealthCare Announces Strategic Plan And Senior Management

Enhancements 476

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9.1.14 Sep 18, 2012: Hycor Opens European Center Of Operations In Germany To Support European

Distributors And Customers 477

9.1.15 Sep 17, 2012: Pathway Genomics And MD Revolution Partner To Incorporate Genomic And

Mobile Health Technologies Into Chronic Disease Management And Prevention 477

9.1.16 Sep 17, 2012: Boehringer Ingelheim To ShutDown One API Plant In Petersburg, Virginia 478

9.1.17 Sep 12, 2012: Nordion Announces Strategic Realignment Of Business 478

9.1.18 Sep 10, 2012: Icon Expands US And UK Bioanalytical Laboratories 479

9.1.19 Sep 07, 2012: Charles River Opens New Biomedical Diagnostic Facility In Wilmington,

Massachusetts 480

9.1.20 Aug 29, 2012: Bio-Rad Opens Digital Biology Center To Develop Products For R&D Markets

Based On Its Droplet Digital Technology 480

9.1.21 Aug 14, 2012: Morphotek Opens New Manufacturing Plant In Exton, US 481

9.1.22 Aug 13, 2012: Elan Announces Plan To Spin-Off Discovery Science And Neotope Biosciences To

Shareholders 481

9.1.23 Aug 01, 2012: Baxter Breaks Ground On $1 Billion Manufacturing Plant In Georgia, US 483

9.1.24 Jul 24, 2012: Life Technologies And SATuRN Collaborate To Increase Access To HIV Testing In

Africa 483

9.1.25 Jul 20, 2012: Seegene To Make Partnership Push With New Multiplex Real-Time PCR Tech 484

9.1.26 Jun 26, 2012: Roche To Shut New Jersey Site, Eliminate 1,000 Jobs 485

9.1.27 Jun 21, 2012: Gentris Partners With Shanghai Institutes of Preventative Medicine 486

9.1.28 Jun 07, 2012: PerkinElmer To Create New Personalized Health Innovation Center of Excellence

In Massachusetts, US 487

9.1.29 Jun 05, 2012: Roche Diagnostics Enters Strategic Alliance With med fusion That Recognizes As

Roche MCOE 487

9.1.30 May 31, 2012: N-of-One Signs Agreement With Foundation Medicine To Provide First Patient-

Specific Genomic Diagnostic Solution For Precision Oncology 488

9.1.31 May 23, 2012: Cold Spring Harbor Laboratory Joins Illumina Genome Network 488

9.1.32 May 22, 2012: New York Genome Center Announces Formal Commencement Of Collaborative

Relationship With Illumina 489

9.1.33 May 14, 2012: KineMed And CHDI Foundation Collaborate To Develop New Biomarkers Of

Disease Progression And To Evaluate Potential Therapeutics For Huntington‘s Disease 490

9.1.34 May 07, 2012: Werfen Decides To End Beckman Coulter Hemostasis Alliance 490

9.1.35 Apr 24, 2012: Reaction Biology Opens New Protein Production Facility In US 491

9.1.36 Apr 24, 2012: Luminex Expands Life Science And Biodefense Groups 491

9.1.37 Apr 23, 2012: Life Technologies To Build Additional $20m Cell Culture Facility In Scotland 492

9.1.38 Apr 02, 2012: CaridianBCT And Terumo Transfusion Become Terumo BCT 492

9.1.39 Mar 19, 2012: OPKO Health Expands Collaboration With Arctic Partners 493

9.1.40 Mar 12, 2012: Nelson Labs Acquires Building To Accommodate Growth 493

9.1.41 Mar 12, 2012: SAW Instruments Expands Presence In US 494

9.1.42 Mar 06, 2012: Lab21 And ITOR Launch Clinical Genomics Center In US 494

9.1.43 Mar 06, 2012: Almac Adds New Commercial Packaging Facility In Audubon, Pennsylvania 495

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9.1.44 Mar 02, 2012: Rubicon Genomics Selects Velesco To Manufacture TransPLEX RNA

Amplification Kits For Clinical Diagnostic Use 495

9.1.45 Mar 01, 2012: Abbott To Build Nutrition Manufacturing Facility In Ohio 496

9.1.46 Feb 27, 2012: Trovagene Partners With Leomics To Expand Business Development Activities 497

9.1.47 Feb 14, 2012: BD And PEPFAR Launch Center For Excellence In Phlebotomy And Specimen

Collection At KMTC 497

9.1.48 Jan 24, 2012: Precision Therapeutics Enhances Straightforward Approach To Personalizing

Cancer Care 498

9.1.49 Jan 24, 2012: Radient Pharma Introduces Its 2012 Sales, Advertising And Outreach Plan

Presentation 498

9.1.50 Jan 19, 2012: BD And Mercy/ROi Collaborate To Improve Quality Of Care And Reduce Costs 499

9.1.51 Jan 06, 2012: Thermo Fisher Scientific Introduces Unity Lab Services 500

9.1.52 Jan 05, 2012: MonoSol And Midatech Launch MidaSol Therapeutics 501

9.2 Research And Development 501

9.2.1 Nov 07, 2012: MJFF And NINDS Collaborate On Parkinson's Disease Biomarker Discovery

Project 501

9.2.2 Oct 29, 2012: Agfa HealthCare And Le CHU de Quebec Announce Three-Year Collaboration To

Conduct Research For Integrated Digital Pathology Solution 502

9.2.3 Sep 19, 2012: Ten Pharmaceutical Companies Unite To Accelerate Development Of New

Medicines 503

9.2.4 Aug 15, 2012: Biogen Idec And Regulus Therapeutics Form Collaboration To Explore microRNA

Biomarkers For Disease Monitoring And Response To Therapy 504

9.2.5 Aug 15, 2012: Epic Sciences Announces Six Pharma Circulating Tumor Cell Collaborations 504

9.2.6 Apr 23, 2012: Ezose And Hirosaki University To Collaborate In Glycomics Research To Find New

Cancer Biomarkers 505

9.2.7 Apr 02, 2012: Metabolon Enters Biomarker Research Collaboration With Metabolon 505

9.2.8 Mar 20, 2012: Transgenomic And MD Anderson Collaborate On Circulating Tumor Cell Study

Using ICE COLD-PCR 506

9.2.9 Mar 14, 2012: GE Healthcare And Intel To Establish Companies‘ First Joint Technology

Evaluation Laboratory In Israel 506

9.2.10 Mar 08, 2012: Covidien Opens Four Global R&D Centers To Broaden Innovation Focus And

Capabilities 507

9.2.11 Jan 12, 2012: Alere Maintains Exclusive Option To License Miraculins 508

9.2.12 Jan 09, 2012: Bayer HealthCare To Share Lab Space With Start-Up Companies 508

9.3 Legal and Regulatory 509

9.3.1 Nov 09, 2012: Novartis‘s Colorado Facility Obtains Clearance From FDA Inspectors 509

9.3.2 Nov 07, 2012: Fluidigm Files Lawsuit Against NanoString For False And Misleading Advertising

Under Lanham Act 509

9.3.3 Nov 02, 2012: Enzo Awarded $49m In Trial Against Applera 510

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9.3.4 Oct 22, 2012: Alere Receives FDA Warning Letter Over Weak Response To Manufacturing

Errors 510

9.3.5 Oct 18, 2012: Complete Genomics Announces Court's Favorable Ruling In Patent Litigation

Against Illumina 510

9.3.6 Oct 15, 2012: Genetic Technologies Files Patent Infringement Suits Against Multiple Alleged

Infringers In US 511

9.3.7 Oct 15, 2012: AspenBio Pharma Proposes Corporate Name Change To Venaxis 511

9.3.8 Oct 15, 2012: Fluxion Registers South San Francisco Facility As Medical Device Establishment

With FDA 512

9.3.9 Oct 11, 2012: CorMedix Announces Successful Completion Of ISO 13485 Certification Audit 512

9.3.10 Oct 04, 2012: Hologic Announces Favorable Ruling In Litigation With Becton, Dickinson 512

9.3.11 Sep 26, 2012: Abaxis Announces Settlement Of Patent Litigation With Cepheid 513

9.3.12 Sep 18, 2012: AspenBio Announces Dismissal Of Class Action And Chipman Lawsuits By US

District Court 513

9.3.13 Sep 13, 2012: Promega Announces Federal Judge Overturns Jury Verdict In Patent Rights Case

514

9.3.14 Sep 10, 2012: Nordion Announces Decision In Arbitration With AECL Over Canceled MAPLE

Project 514

9.3.15 Sep 05, 2012: RayBiotech Establishes Formal Compliance In Both Good Manufacturing And

Good Laboratory Practices 515

9.3.16 Aug 30, 2012: Genetic Technologies Files Patent Infringement Suit Against Reproductive

Genetics Institute In US 516

9.3.17 Aug 29, 2012: Illumina Announces Favorable Outcome Of Patent Litigation Against Helicos

BioSciences 516

9.3.18 Aug 23, 2012: United Drug Files Motion To Dismiss Legal Action By Catalent Pharma 517

9.3.19 Aug 20, 2012: Agendia Receives ISO Certification For Facilities In Amsterdam And Irvine 517

9.3.20 Aug 17, 2012: LabCorp Commends CDC For Revised HCV Testing Guidelines 518

9.3.21 Aug 16, 2012: US Court of Appeals Upholds Myriad's Gene Patents 518

9.3.22 Aug 10, 2012: EKF Announces Settlement Agreement With HemoCue 519

9.3.23 Aug 03, 2012: Meso Scale Diagnostics Announces ISO 9001:2008 And ISO 13485:2003

Certifications 519

9.3.24 Aug 01, 2012: MDxHealth CLIA Laboratory In California Receives CAP Accreditation 520

9.3.25 Jul 30, 2012: HTG Molecular Diagnostics Achieves ISO 13485:2003 Certification 520

9.3.26 Jul 24, 2012: PerkinElmer Receives State of Connecticut Clinical Laboratory Licensure And CLIA

Certificate Of Registration For Global DNA Sequencing Services 520

9.3.27 Jul 11, 2012: FDA Issues Class I Recall On Alere Triage Diagnostic Tests 521

9.3.28 Jul 09, 2012: Siemens Receives FDA Warning Letter For Violations Of CGMP Requirements 521

9.3.29 Jul 06, 2012: Sequenom Addresses Preliminary Injunction Decision, Reaffirms Defense Of Patent

522

9.3.30 Jun 28, 2012: Nodality Receives CLIA Certification For Clinical Laboratory 522

9.3.31 Jun 27, 2012: Excelsior Medical Retracts False Statements, Settles Case With Ivera Medical 523

9.3.32 Jun 18, 2012: Illumina Files Second Patent Infringement Suit Against Complete Genomics 523

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9.3.33 Jun 12, 2012: Progenika Receives CAP Certification For Its CLIA Labs 524

9.3.34 May 18, 2012: Champions Oncology Receives CLIA Certification 524

9.3.35 May 14, 2012: Helicos Settles Its Patent Litigation Against Pacific Biosciences 524

9.3.36 May 14, 2012: Helicos Settles Patent Litigation Against Pacific Biosciences 525

9.3.37 May 10, 2012: Metabolon‘s Shanghai Jiao Tong University Lab Receives Validation 525

9.3.38 May 08, 2012: Beckman Coulter Receives CLIA Certificate And Licensure For Clinical

Sequencing 525

9.3.39 Apr 30, 2012: Vermillion Resolves Non-Contingent Claims With Bio-Rad 526

9.3.40 Apr 24, 2012: FDA Notifies Class I Recall Of Roche‘s Elecsys Troponin I and Elecsys Troponin I

STAT Immunoassays 526

9.3.41 Apr 23, 2012: Essential Medical Dismisses Patent Case Against Masimo And Cercacor 527

9.3.42 Mar 26, 2012: Supreme Court of the United States Remands Gene Patenting Case 527

9.3.43 Mar 15, 2012: QIAGEN Welcomes US Guideline Changes To Recommend HPV Testing As Part

Of Cervical Cancer Screening 528

9.3.44 Mar 15, 2012: Seahorse Bioscience‘s Labware Division Achieves ISO 9001:2008 Certification 529

9.3.45 Mar 13, 2012: Roche Receives Request For Additional Information From FTC 530

9.3.46 Mar 05, 2012: Atossa Genetics' National Reference Laboratory For Breast Health Receives CLIA

Certification 530

9.3.47 Mar 01, 2012: Illumina Announces Outcome Of First Phase Of Its Patent Litigation Against

LadaTech 531

9.3.48 Mar 01, 2012: Berg Diagnostics Receives CLIA Certification And Launches New Vitamin D Assay

531

9.3.49 Mar 01, 2012: LadaTech Announces Illumina Found To Infringe Patent 532

9.3.50 Feb 22, 2012: Sequenom Files Motion For Preliminary Injunction Against Aria Diagnostics 532

9.3.51 Feb 21, 2012: Genetic Technologies Successfully Concludes Second Patent Infringement Suit In

US 533

9.3.52 Feb 16, 2012: Illumina Announces Favorable Patent Claim Construction Ruling In Litigation

Against Complete Genomics 533

9.3.53 Feb 03, 2012: London High Court Affirms 3M Legal Victory; Awards Company Litigation Fees

And Costs 533

9.3.54 Feb 01, 2012: Foundation Medicine Receives CLIA Certification For Its Genomic Sequencing

Laboratory 534

9.3.55 Jan 22, 2012: MDxHealth Receives CLIA Certification And California State License For Its

Clinical Laboratory 535

9.3.56 Jan 18, 2012: PrimeraDx Receives ISO 13485:2003 Certification 535

9.3.57 Jan 17, 2012: Agilent Technologies Lists LC And Mass Spec Systems As Class I Medical

Devices With FDA 536

9.3.58 Jan 11, 2012: Biotage Is Subject To Extended Patent Litigation In US 536

9.3.59 Jan 10, 2012: US Court of Appeals Upholds Celsis IVT Injunction Against Life Technologies In

LiverPool Patent Infringement Lawsuit 537

9.3.60 Jan 09, 2012: Transgenomic And Power3 Medical Resolve All Outstanding Litigation Proceedings

And Disputes 537

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9.4 Government and Public Interest 538

9.4.1 Nov 21, 2012: OraSure Supports New Routine HIV Screening Recommendations By US

Preventive Services Task Force 538

9.4.2 Nov 20, 2012: New Test For Tuberculosis Could Improve Treatment, Prevent Deaths In Southern

Africa: Study 539

9.4.3 Nov 20, 2012: ACOG Finds cffDNA Test To Be Promising Against Three Genetic Disorders 540

9.4.4 Nov 02, 2012: CMS Issues Final Rule On Medicare‘s Payments For Physician Fees For 2013 540

9.4.5 Nov 01, 2012: Researchers Use Blood Testing To Predict Level Of Enzymes That Facilitate

Disease Progression 541

9.4.6 Oct 16, 2012: New Noninvasive Test For Colorectal Cancer Shows Promise: AACR 542

9.4.7 Oct 15, 2012: VeriStrat Predicts Response But Not Survival Benefit From Erlotinib: Study 543

9.4.8 Aug 16, 2012: CDC Now Recommends All Baby Boomers Receive One-Time Hepatitis C Test 543

9.4.9 Aug 06, 2012: Cytomedix Announces Medicare Coverage For Autologous PRP Gel In Chronic

Wound Care 544

9.4.10 Jun 25, 2012: Loyola University Chicago Stritch School of Medicine Study Of Two Vitamin D

Tests Find Inaccurate 545

9.4.11 Jun 21, 2012: Blood Test For Pregnant Women Could Predict Risk Of Having Dangerously Small

Babies 545

9.4.12 Jun 20, 2012: UW Research Shows New Prognosis Tool For Deadly Brain Cancer 546

9.4.13 Jun 19, 2012: Genetic Marker In Vitamin D Receptor Gene Associated With Increased Pancreatic

Cancer Survival 547

9.4.14 Jun 15, 2012: US Senator John Kerry Introduces Senate Resolution Urging Federal Support To

Improve Early Detection Of Prostate Cancer 548

9.4.15 Jun 05, 2012: Noninvasive Genetic Test For Down Syndrome And Edwards Syndrome Highly

Accurate: Study 549

9.4.16 Jun 05, 2012: Blood Test Identifies Increased Risk Of Death Following Surgery: McMaster

Researchers 550

9.4.17 Jun 05, 2012: Battelle Introduces Industry-First Drug Discovery CoLaborative 551

9.4.18 Jun 02, 2012: Researchers Discover DNA Marker That May Indicate Differences In Breast

Cancer 552

9.4.19 May 31, 2012: Researchers Identify Promising Biomarkers And New Therapeutic Targets For

Kidney Cancer: UC Davis 553

9.4.20 May 31, 2012: Nanotechnology Advancement Could Significantly Improve Medical Tests:

Princeton University 554

9.4.21 May 29, 2012: Researchers Discover Biomarker For Advanced Bile Duct Fibrosis And Bile Duct

Cancer: The George Washington University 555

9.4.22 May 24, 2012: New Prostate Cancer Screening Guidelines Face Tough Sell, Study Suggests 556

9.4.23 May 22, 2012: New Biomarkers Reveal Evidence Of Radiation Exposure: Medical College of

Wisconsin 557

9.4.24 May 22, 2012: Biomedical Engineers At UC Davis Develops Microfluidic Chip To Test For Latent

Tuberculosis 558

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9.4.25 May 19, 2012: CDC Announces First Ever National Hepatitis Testing Day And Proposes That All

Baby Boomers Be Tested Once For Hepatitis C 559

9.4.26 May 17, 2012: Researchers From University of Florida Uses Traditional Microscope-Based

Diagnosis Method As Starting Point Against Tuberculosis 560

9.4.27 May 17, 2012: NIH-Led Study Finds Genetic Test Results Do Not Trigger Increased Use Of

Health Services 561

9.4.28 May 15, 2012: New Biomarker Test Predicts Arthritis At Much Earlier Stage: University of

Missouri-Columbia 562

9.4.29 May 15, 2012: Early Biomarker For Pancreatic Cancer Identified: University of California, San

Diego 563

9.4.30 May 15, 2012: FDA Expands Use For FilmArray Respiratory Panel 564

9.4.31 May 14, 2012: Genetic Test Identifies Eye Cancer Tumors Likely To Spread: Washington

University School of Medicine 565

9.4.32 May 07, 2012: PSA Screening To Detect Prostate Cancer Can Be Beneficial To Younger And At-

Risk Men: New Study 566

9.4.33 Apr 25, 2012: New Diagnostic Tool Determines Aggressiveness Of Prostate Cancer: UCF 567

9.4.34 Apr 24, 2012: New Microdevice Enables Culture Of Rare Circulating Tumor Cells From Blood 568

9.4.35 Apr 18, 2012: Researchers Develop New Optical Imaging System For Rapid And Accurate

Diagnosis Of Malaria 569

9.4.36 Apr 17, 2012: Saliva Test Could Dramatically Increase Detection Of Oral Cancer: MSU 570

9.4.37 Apr 17, 2012: Northwestern Medicine Scientist Develops First Blood Test To Diagnose Major

Depression In Teens 571

9.4.38 Apr 16, 2012: Biosensia To Showcase Latest Diagnostic Developments At AACC Oak Ridge

Conference 572

9.4.39 Apr 09, 2012: Researchers Identify Genes That May Help In Ovarian Cancer Diagnosis And

Prognosis 572

9.4.40 Apr 06, 2012: Invasive Heart Test Being Dramatically Overused, Stanford Study Shows 573

9.4.41 Apr 05, 2012: Cleveland HeartLab‘s Cardiovascular Disease Risk Testing To Be Featured At

TEDMED 2012 574

9.4.42 Apr 04, 2012: Caris Life Presents Novel Findings Regarding Biological Role Of Circulating

Microvesicles 575

9.4.43 Mar 31, 2012: Biomarker Identified In Relation To Drug Response In Refractory Urothelial Cancer

576

9.4.44 Mar 29, 2012: Complete Genomics Accepts DNA Obtained From Saliva For Whole Human

Genome Sequencing 576

9.4.45 Mar 27, 2012: Siemens Showcases Broad Portfolio Of Infectious Disease Testing Capabilities At

ECCMID 2012 577

9.4.46 Mar 20, 2012: Study Shows Colorectal Cancer Screening Rates High In Patients With Multiple

Health Problems 577

9.4.47 Mar 16, 2012: FDA Proposes Lower Risk Classification For Certain Tuberculosis Tests 578

9.4.48 Mar 16, 2012: Inflammatory Biomarkers Improve Clinical Prediction Of Mortality In COPD 579

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9.4.49 Mar 15, 2012: New Professional Guidelines Recognize Benefit Of Genotyping HPV 16 And 18

For Cervical Cancer Prevention By Assessing Individual Patient Risk: Roche 580

9.4.50 Mar 14, 2012: Study Suggests Link Between Helicobacter pylori Bacteria And Adult Type 2

Diabetes 581

9.4.51 Mar 14, 2012: Predictive Biosciences To Present At GTCbio Oncology Biomarkers Conference

581

9.4.52 Mar 05, 2012: Pall Life Sciences Showcases Innovative Syringe Filter At Pittcon Conference 582

9.4.53 Feb 29, 2012: Cleveland Clinic Children's Hospital Launches Study To Genetically Test For

Autism 583

9.4.54 Feb 27, 2012: New Research Study Could Lead To More Timely Diagnosis And Aid Clinical

Management During Flu Season 584

9.4.55 Feb 04, 2012: Henry Ford Hospital Researchers Identity Potential Biomarker For Osteoarthritis

585

9.4.56 Feb 02, 2012: Scripps Research Scientists Demonstrate Effective New 'Biopsy In A Blood Test'

To Detect Cancer 585

9.4.57 Feb 02, 2012: Study Shows An Investigational Urine Test Can Predict High-Risk Prostate Cancer

In Men Who Choose ‗Watchful Waiting‘ 587

9.4.58 Feb 02, 2012: New Research Confirms Need For Lung Cancer Testing: UCCC 588

9.4.59 Feb 01, 2012: Blood Test Accurately Distinguishes Depressed Patients From Healthy Controls:

MGH 589

9.4.60 Jan 27, 2012: Bruker And SAT Announce Joint Publication On SISCAPA-MALDI-TOF Mass

Spectrometry For Biomarker Validation And Clinical Research 590

9.4.61 Jan 24, 2012: RI-MUHC-Led Study Compares Saliva Self-Test To Blood Test 591

9.4.62 Jan 19, 2012: AUA Applauds Passage Of New Jersey Legislation Opposing USPSTF PSA

Testing Recommendations And Guaranteeing Coverage 591

9.4.63 Jan 17, 2012: New Jersey Leads Nation In Opposing USPSTF PSA Testing Recommendation 592

9.4.64 Jan 12, 2012: Moffitt Cancer Center Researchers Find New, Noninvasive Way To Identify Lymph

Node Metastasis 593

9.4.65 Jan 12, 2012: NIH Scientists Identify New Approach To View Inner Workings Of Viruses 594

9.4.66 Jan 10, 2012: New Fibrosis Classification Improves Accuracy Of Diagnosis In Hepatitis C 595

9.4.67 Jan 10, 2012: GE Healthcare Presents At JP Morgan Healthcare Conference On Role Of

Molecular And Companion Diagnostics In Personalized Medicine 596

9.4.68 Jan 10, 2012: NIST Standard Available For Better Diagnosis, Treatment Of Cytomegalovirus 596

9.4.69 Jan 09, 2012: Most Parents Who Get Tested For Breast Cancer Genes Share Results With Their

Children: Study 597

9.4.70 Jan 09, 2012: Biomarkers Identify Acute Kidney Injury In Emergency Patients 598

9.4.71 Jan 08, 2012: New Test Spots Early Signs Of Inherited Metabolic Disorders: UC San Diego 598

9.5 Product News 599

9.5.1 Nov 28, 2012: Cdex To Showcase ValiMed G4 System At 47th ASHP Midyear Clinical Meeting

And Exhibition 599

9.5.2 Nov 28, 2012: Telome Health To Launch TeloTest In Q1 2013 600

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9.5.3 Nov 27, 2012: CardioDx Announces Participation In Landmark NHLBI Trial Of Strategies For

Assessment Of Stable Patients With Symptoms Of CAD 601

9.5.4 Nov 19, 2012: Daxor Signs Trial Agreement With PCI Nuclear Pharmacy in Arizona For Blood

Volume Analyzer-100 602

9.5.5 Nov 15, 2012: CardioDx Announces Data Demonstrating Clinical Utility Of Its Gene Expression

Test For Obstructive Coronary Artery Disease In Patients 65 Or Older 602

9.5.6 Nov 14, 2012: Associates of Cape Cod Announces Use Of Fungitell Assay In Diagnosis Of

Invasive Fungal Infections 603

9.5.7 Nov 13, 2012: Nanosphere Receives FDA Clearance To Market Test For Detection Of CYP2C19

Mutations Affecting Drug Metabolism 603

9.5.8 Nov 12, 2012: CardioDx To Present Corus CAD At Lazard Capital Markets And Piper Jaffray

Investor Conferences 604

9.5.9 Nov 09, 2012: Natera‘s Non-Invasive Prenatal Testing Technology Shows Unparalleled

Specificity, Sensitivity In Clinical Data Presented At American Society of Human Genetics 604

9.5.10 Nov 08, 2012: Cytomedix Receives FDA 510(K) Clearance For Angel cPRP System For

Processing Blood And Bone Marrow Aspirate 605

9.5.11 Nov 08, 2012: CardioDx Announces New Data Supporting Clinical Utility And Validity Of Corus

CAD At American Heart Association Scientific Sessions 2012 606

9.5.12 Nov 08, 2012: Roche Receives Health Canada Approval For Cobas AmpliPrep/Cobas TaqMan

CMV Test 607

9.5.13 Nov 08, 2012: Diazyme Receives FDA 510(k) Clearance For Cystatin C POC Test Kit On Smart

Point of Care System 607

9.5.14 Nov 07, 2012: Life Technologies Announces Next-Gen Digital PCR Instrument Designed For

Widespread Adoption 608

9.5.15 Nov 07, 2012: Caris Life Sciences Selects Illumina‘s MiSeq System To Enable Next-Generation

Sequencing As Part Of Its Molecular Profiling Service 609

9.5.16 Nov 06, 2012: IntegenX Announces Commercial Introduction Of mRNA Library Preparation Kit

For Next Generation Sequencing 609

9.5.17 Nov 06, 2012: Affymetrix Introduces Axiom miRNA Target Site Genotyping Arrays 610

9.5.18 Nov 06, 2012: Verinata Health's verifi Prenatal Test Expanded To Include Most Common Sex

Chromosome Abnormalities 611

9.5.19 Nov 05, 2012: Atherotech‘s VAP Lipid Panel Helps Predict Heart Attack Risk And Improved

Outcomes In African Americans 611

9.5.20 Nov 05, 2012: Ariosa Diagnostics To Present Clinical Data On Harmony Prenatal Test At ASHG

Annual Meeting 612

9.5.21 Nov 01, 2012: Affymetrix Introduces Axiom Biobank Arrays For Genotyping Studies 613

9.5.22 Oct 29, 2012: Epocal Receives FDA Clearance For Chloride Test 614

9.5.23 Oct 29, 2012: CardioDx Announces Clinical And Scientific Presentations At American Heart

Association Scientific Sessions 2012 614

9.5.24 Oct 29, 2012: Epocal Receives FDA Clearance For Creatinine Test 615

9.5.25 Oct 25, 2012: Verinata Health Files Patent Infringement Action Against Ariosa And LabCorp 616

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9.5.26 Oct 24, 2012: Atherotech‘s VAP Lipid Panel Is Highlighted In Scientific Presentations At 2012

American Heart Association Scientific Sessions 616

9.5.27 Oct 24, 2012: Verinata Health Announces Presentations Of Its Verifi Prenatal Test At National

Society Of Genetic Counselors Conference 617

9.5.28 Oct 23, 2012: Cytonics Receives Notice Of Allowance For Patent Related To FACT Diagnostic

For Back And Joint Pain 618

9.5.29 Oct 22, 2012: Prometheus Presents Five Abstracts Of Prometheus Anser IFX Assay At ACG

2012 Scientific Meeting 619

9.5.30 Oct 18, 2012: HTG Molecular To Unveil Edge System At AMP Conference 619

9.5.31 Oct 12, 2012: SQI Diagnostics To Launch SQiDlite Multiplexing System At AAPS 620

9.5.32 Oct 11, 2012: Akonni Biosystems To Present Results Of Its Work To Develop TruTip Automated

Solution For Extracting Cell-Free DNA From Maternal Plasma At ASHG Conference 620

9.5.33 Oct 11, 2012: BD Veritor System For Rapid Detection Of RSV Receives FDA 510(k) Clearance

For Nasopharyngeal Wash, Aspirate And Swab In Transport Media Specimens 621

9.5.34 Oct 10, 2012: Myriad's HRD Score Detects Loss Of DNA Repair Function In Ovarian Cancer 622

9.5.35 Oct 09, 2012: Focus Diagnostics And 3M Launch FDA-Cleared Simplexa Test On 3M Cycler For

Molecular Influenza And Respiratory Virus Testing By Moderate Complexity Healthcare Facilities 622

9.5.36 Oct 09, 2012: OraSure Announces Availability Of OraQuick In-Home HIV Test To Consumers

Across US 623

9.5.37 Oct 03, 2012: Roche Announces Availability Of Cobas TaqMan HIV-1 Test v2.0 In US 624

9.5.38 Oct 03, 2012: BD Diagnostics Receives 510(k) FDA Clearance For Nasopharyngeal Wash,

Aspirate And Swab In Transport Media Specimens On BD Veritor System For Rapid Detection Of RSV 624

9.5.39 Oct 01, 2012: Inform Genomics Announces Positive Top-Line Results In First Phase Of

Development For Onpart Personalized Medicine Product 625

9.5.40 Oct 01, 2012: IntegenX Announces Commercial Availability Of RapidHIT 200 System In US 626

9.5.41 Oct 01, 2012: Micronics Announces Commercial Launch Of ABORhCard 626

9.5.42 Sep 27, 2012: Life Technologies Receives FDA Clearance For OpTmizer CTS T-Cell Expansion

Tissue Culture Medium 627

9.5.43 Sep 26, 2012: Aeterna Zentaris Provides Update On NDA Filing For AEZS-130 As Diagnostic

Test For Adult Growth Hormone Deficiency 628

9.5.44 Sep 26, 2012: PrimeraDx Receives National Cancer Institute Grant To Develop B-Cell

Lymphoma Panel On ICEPlex System 628

9.5.45 Sep 25, 2012: Gynecor Adds New Cervical Cancer LAB Technology To Help Physicians Identify

Patients At Risk For Cervical Cancer, Improve Treatment Decisions 629

9.5.46 Sep 25, 2012: Genetic Technologies Announces BREVAGen Attains Clearance For Sale Into

Florida 629

9.5.47 Sep 25, 2012: NanoString Launches Single Cell Gene Expression Solution For nCounter Analysis

System 630

9.5.48 Sep 24, 2012: Study At Columbia University Using Daxor's Blood Volume Analyzer Demonstrates

Hidden Polycythemia In Heart Failure Patients 631

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9.5.49 Sep 24, 2012: BD Diagnostics Receives FDA 510(k) Clearance For Nasopharyngeal Wash,

Aspirate And Swab In Transport Media Specimens On BD Veritor System For Rapid Detection Of Flu A +

B 631

9.5.50 Sep 24, 2012: Ariosa Diagnostics Announces Publication Of Clinical Study On Non-invasive

Prenatal Testing For Fetal Trisomy 13 With Harmony Prenatal Test 632

9.5.51 Sep 18, 2012: Fyodor Biotechnologies Receives Phase II SBIR Grant To Develop Broad Urine-

Based Diagnostic Test For Malaria 633

9.5.52 Sep 17, 2012: LipoScience Announces Publication Of Results From Clinical Study In American

Journal of Cardiology 633

9.5.53 Sep 17, 2012: Roche Announces Commercial Availability Of Cobas AmpliPrep/Cobas TaqMan

CMV Test In US 634

9.5.54 Sep 12, 2012: GenMark Diagnostics Receives FDA Clearance For eSensor RVP Test 635

9.5.55 Sep 11, 2012: Cytomedix To Highlight AutoloGel System In Multiple Poster Presentations At

SAWC Fall 2012 635

9.5.56 Sep 06, 2012: PTS Signs Agreement To Provide Point-of-Care Lipid Testing To Life Line

Screening 636

9.5.57 Sep 06, 2012: Polymer Technology Signs Agreement With Life Line Screening To Supply

CardioChek PA Test System 637

9.5.58 Sep 05, 2012: BioReliance To Launch Reconstructed Skin Micronucleus Assay 637

9.5.59 Sep 05, 2012: Cytomedix To Present AutoloGel System In Two Presentations At 4th Congress Of

WUWHS 2012 In Japan 638

9.5.60 Sep 05, 2012: Ariosa Diagnostics Reports Publication Of Clinical Utility Of Harmony Prenatal Test

In General Screening Population 639

9.5.61 Sep 05, 2012: LipoScience Receives FDA Clearance For Vantera Clinical Analyzer 640

9.5.62 Sep 04, 2012: Transgenomic And NYU Collaborate On Lung Cancer Study Using Ice Cold-PCR

For Blood-Based Mutation Detection 640

9.5.63 Aug 29, 2012: Siemens Unveils New Assay For Specific And Stable Free Protein S Antigen

Testing 641

9.5.64 Aug 16, 2012: AWDT Launches ACE Axcel Clinical Chemistry System 642

9.5.65 Aug 14, 2012: Beckman Coulter Announces Publication Of Positive Study Results In Journal of

The American College of Cardiology Distinguish PAPP-A From Other New Cardiovascular Biomarkers 643

9.5.66 Aug 14, 2012: CardioDx To Present Corus CAD At Wedbush PacGrow Life Sciences

Management Access Conference 644

9.5.67 Aug 14, 2012: California Schools VEBA Implements Pathway Fit Nutrigenetic Test For Weight-

Loss 644

9.5.68 Aug 13, 2012: Miraculins To Launch PreVu Skin Cholesterol Test In Canada Through London

Drugs 645

9.5.69 Aug 10, 2012: Miraculins To Receive $0.13m Grant For PreVu From Province of Manitoba 646

9.5.70 Aug 09, 2012: Veridex Reports Updated Coding And Payment On Horizon For Circulating Tumor

Cell Testing 646

9.5.71 Aug 08, 2012: CardioDx Announces Medicare Coverage For Corus CAD Gene Expression Test

For Diagnosis Of Obstructive Coronary Artery Disease 647

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9.5.72 Aug 07, 2012: LabCorp Completes And Publishes Clinical Study For Development And Validation

Of PCR Assay For Bacterial Vaginosis 648

9.5.73 Aug 07, 2012: AspenBio Pharma Submits Pre-IDE Information Package To FDA For AppyScore

Appendicitis Test System 648

9.5.74 Aug 07, 2012: Aeterna Zentaris Granted US Patent For AEZS-130 As Diagnostic Test For Adult

Growth Hormone Deficiency 649

9.5.75 Aug 06, 2012: SWOG Selects Sequenta‘s LymphoSIGHT Platform For Use In 180-Patient Mantle

Cell Lymphoma Clinical Trial 649

9.5.76 Aug 06, 2012: University of Michigan Informs Interleukin Genetics Of Study Results Using PST

Genetic Test In Determining Frequency Of Dental Cleanings 650

9.5.77 Aug 06, 2012: Cytomedix Announces Medicare Coverage For Autologous PRP Gel In Chronic

Wound Care 651

9.5.78 Aug 03, 2012: Daxor Announces Sale Of BVA-100 Blood Volume Analyzer To Hospital Located

In Arizona 652

9.5.79 Aug 02, 2012: Idaho Technology Provides FilmArray Clinical Diagnostic Pipeline Update 652

9.5.80 Aug 01, 2012: AspenBio Pharma Enhances Product Development And Manufacturing

Capabilities In Preparation For Clinical Trial And Commercialization Of AppyScore 653

9.5.81 Jul 31, 2012: CardioDx‘s Corus CAD Gene Expression Test Performs Equally Well In Both

Women And Men for Assessment Of Obstructive Coronary Artery Disease: New Study 654

9.5.82 Jul 31, 2012: New York Genome Center Purchases Four Ion Proton Sequencers For Its New

Innovation Center 655

9.5.83 Jul 31, 2012: Prometheus Launches PROMETHEUS Anser IFX To Help Guide Inflammatory

Bowel Disease Management 656

9.5.84 Jul 30, 2012: MolecularMD Submits PMA Application To FDA For BCR-ABL T315I Mutation Test

656

9.5.85 Jul 30, 2012: 23andMe Submits First Round Of FDA 510(k) Documentation To FDA 657

9.5.86 Jul 26, 2012: RainDance Technologies Launches First Access Program For RainDrop Digital

PCR System 658

9.5.87 Jul 25, 2012: Cepheid Announces Release Of Updated Xpert BCR-ABL Monitor Test 659

9.5.88 Jul 25, 2012: Genomic Health Announces Publication Of Clinical Outcomes Study For Biomarker

Discovery Using Next Generation Sequencing 659

9.5.89 Jul 24, 2012: Aeterna Zentaris Requests Fast Track Designation From FDA For AEZS-130 As

Diagnostic Test For AGHD 660

9.5.90 Jul 24, 2012: Genalyte Launches Maverick ENA 4 Assay Kit 661

9.5.91 Jul 24, 2012: Ariosa Diagnostics Completes Clinical Study Of Harmony Prenatal Test On General

Pregnant Patient Population 661

9.5.92 Jul 23, 2012: FDA Grants CLIA Waiver To bioLytical INSTI Rapid HIV Test 662

9.5.93 Jul 19, 2012: T2 Biosystems Announces Data Presentation On T2Hemostasis At American

Association for Clinical Chemistry Annual Meeting 663

9.5.94 Jul 19, 2012: CBLPath Launches NRAS Gene Mutation Analysis Assay 664

9.5.95 Jul 18, 2012: Daxor Announces Placement Of BVA-100 Blood Volume Analyzer At New York

Presbyterian/Weill Cornell Medical Center 664

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9.5.96 Jul 17, 2012: Beckman Coulter‘s New AU5800 System Featured At 2012 AACC/ASCLS Annual

Meeting And Clinical Lab Expo 665

9.5.97 Jul 17, 2012: BD Receives FDA 510(k) Clearance For BD BACTEC Plus Aerobic/F Blood Culture

Plastic Bottles 666

9.5.98 Jul 17, 2012: Idaho Technology Initiates Clinical Study For FilmArray Blood Culture Identification

Panel 666

9.5.99 Jul 16, 2012: Roche Introduces Mobile Blood Gas Analyzer For Hospital Point Of Care 667

9.5.100 Jul 16, 2012: Metabolon To Showcase Quantose Test At AACC Clinical Lab Expo 667

9.5.101 Jul 12, 2012: Daxor Announces Placement Of BVA-100 Blood Volume Analyzer At North

Alabama Radiopharmacy 668

9.5.102 Jul 11, 2012: Idaho Technology To Present At 2012 AACC Annual Meeting 668

9.5.103 Jul 11, 2012: Courtagen Releases nucSEEKPDx 669

9.5.104 Jul 09, 2012: Genomic Health Releases Results Of Oncotype DX Breast Cancer Test 669

9.5.105 Jul 09, 2012: SurModics IVD To Launch BioFX TMBX At AACC In Los Angeles 670

9.5.106 Jul 06, 2012: QIAGEN Receives FDA Approval Of Therascreen KRAS RGQ PCR Kit For

Colorectal Cancer 671

9.5.107 Jul 06, 2012: Court Denies Preliminary Injunction Motion Against Ariosa Diagnostics 672

9.5.108 Jul 03, 2012: OraSure Receives FDA Clearance For Its OraQuick In-Home HIV Test 672

9.5.109 Jul 02, 2012: Roche Receives FDA Approval For COBAS TaqMan HIV-1 Test 673

9.5.110 Jul 02, 2012: Verinata Health Expands verifi Prenatal Test To Include Turner Syndrome Option

673

9.5.111 Jul 02, 2012: Seegene To Introduce Real-Time Multiple Mutation Detection Technology For

Drug Resistant Mutations In M. tuberculosis At AACC 2012 674

9.5.112 Jun 28, 2012: Abaxis Enters Into Definitive Agreement To Deliver 300 Piccolo Xpress

Instruments For Four-Year Drug Clinical Trial 674

9.5.113 Jun 28, 2012: IBM Recommends Strategy To Help Improve Cervical Cancer Screening And

Treatment In Kenya 675

9.5.114 Jun 27, 2012: OraSure Supports Rapid HIV Testing Initiatives In Recognition Of 18th Annual

National HIV Testing Day 676

9.5.115 Jun 26, 2012: BIT Companies And DRG Diagnostics To Unveil DRG:HYBRID XL Analyzer 677

9.5.116 Jun 26, 2012: WIN Consortium To Initiate Clinical Trial Using Foundation Medicine‘s

FoundationOne 677

9.5.117 Jun 23, 2012: BD Biosciences Launches BD FACSJazz Cell Sorting System 678

9.5.118 Jun 23, 2012: Quantimetrix Launches Complete D 25-OH Vitamin D Control 678

9.5.119 Jun 22, 2012: Accelr8 Presents Study Results For BAC-Xtrax At ASM 2012 679

9.5.120 Jun 22, 2012: Accelr8 Presents Study Results For BACcel Rapid Diagnostic System At ASM

2012 And Receives Acceptance To Present New Blood Study 679

9.5.121 Jun 21, 2012: Siemens Launches Enzygnost Anti-HCV 4.0 Assay 679

9.5.122 Jun 21, 2012: Daxor Announces Placement Of Three BVA-100 Blood Volume Analyzers 680

9.5.123 Jun 20, 2012: BioRealm Secures SBIR Contract To Develop Smokescreen For Tobacco

Addiction 680

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9.5.124 Jun 11, 2012: Metabolon‘s Quantose IR Test Featured In Five Poster Presentations At 2012

American Diabetes Association Meeting 681

9.5.125 Jun 08, 2012: Cytomedix To Present Multiple Poster Presentations On AutoloGel System At

44th Annual Conference Of WOCN 682

9.5.126 Jun 07, 2012: QuantRx Biomedical Provides Corporate Update: Focused On Diagnostics And

Feminine Hygiene Segments 682

9.5.127 Jun 07, 2012: Chembio Files PMA Final Module With FDA For DPP HIV 1/2 Assay 683

9.5.128 Jun 05, 2012: Transgenomic Launches ICE COLD-PCR Kit At 2012 ASCO Annual Meeting 684

9.5.129 Jun 05, 2012: Prospective Study Shows Favorable Overall Survival In Cancer Of Unknown

Primary Patients With Therapy Directed By bioTheranostics' CancerTYPE ID 685

9.5.130 Jun 04, 2012: Quantimetrix Introduces Dropper A1c Diabetes Control 686

9.5.131 Jun 04, 2012: Ariosa Diagnostics Completes First Large Cohort Validation Study On Non-

invasive Prenatal Testing For Fetal Trisomy Detection Using Harmony Prenatal Test 686

9.5.132 Jun 01, 2012: NLA Abstracts Examine Clinical Utility Of Atherotech‘s VAP Lipid Panel In Type

2 Diabetes Treatment, Heart Disease Risk Assessment 687

9.5.133 Jun 01, 2012: ScotlandsDNA Selects DNA Genotek‘s Oragene•DNA Kit For Ancestry Testing

688

9.5.134 Jun 01, 2012: bioTheranostics‘ CancerTYPE ID Shows High Accuracy In A Multi-Site Validation

Study And Improved Performance Compared With Standard Of Care In Metastatic Tumor Diagnosis 689

9.5.135 Jun 01, 2012: LipoScience Announces Study Results Of LDL Particle Levels Using NMR

LipoProfile Test 690

9.5.136 Jun 01, 2012: Salimetrics Introduces New Salivary IL-1 Beta Immunoassay Kit 691

9.5.137 May 31, 2012: Pathwork Diagnostics To Present Three Studies At ASCO Annual Meeting 691

9.5.138 May 31, 2012: Illumina Introduces Nextera XT DNA Sample Preparation Kit 692

9.5.139 May 31, 2012: Verinata Health Announces Introduction Of verifi Prenatal Test 693

9.5.140 May 31, 2012: CardioDx To Present Corus CAD At Jefferies 2012 Global Healthcare

Conference 694

9.5.141 May 30, 2012: Response Genetics Announces Presentation Of Lung Cancer Study Results At

2012 ASCO Annual Meeting 694

9.5.142 May 30, 2012: Biocept To Present Clinical Findings On Circulating Tumor Cells At ASCO

Annual Meeting 695

9.5.143 May 30, 2012: BHD Launches SLCO1B1 Genotype Test To Identify Risk For Developing

Debilitating Myopathy 696

9.5.144 May 29, 2012: Sequenom Reports Recently Released Publication On Sequenom Massarray

Research Use System 697

9.5.145 May 29, 2012: Corgenix Announces Issuance Of Additional US Patent For AspirinWorks (11-

dehydro Thromboxane B2) Test 697

9.5.146 May 29, 2012: Siemens Receives FDA Warning Letter Regarding AD VIA Centaur iPTH

Immunoassay 698

9.5.147 May 24, 2012: Cepheid Receives FDA Clearance For GeneXpert Infinity-80 System For Initial

Use With Xpert Flu Assay 698

9.5.148 May 24, 2012: True Diagnostics Receives CE Mark For TrueDX Platform And TSH Test 699

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9.5.149 May 23, 2012: Lucigen Corporation Receives $2.8m SBIR Grant From NIH For Lucigen

Influenza A, B & RSV test 699

9.5.150 May 21, 2012: HistoRx Announces Application Of AQUA Technology To Assessment Of

Messenger RNA In Tissue 700

9.5.151 May 21, 2012: AB Sciex Launches Next-Generation TripleTOF 5600 System 701

9.5.152 May 21, 2012: Transgenomic Announces CE IVD Mark For WAVE MCE System 702

9.5.153 May 18, 2012: OraSure Technologies Issues Statement On CDC Proposed Draft Guidelines

For Testing Of Baby Boomers For Hepatitis C 702

9.5.154 May 18, 2012: Siemens Receives FDA Clearance For RAPIDPoint 500 System - Lactate Assay

703

9.5.155 May 18, 2012: Siemens Receives CE Mark Approval For RAPIDPoint 500 System - Pleural

Fluid pH Testing 703

9.5.156 May 18, 2012: Sequenom Announces Publication Of Clinical Study Results Using CMM's

MaterniT21 PLUS LDT 704

9.5.157 May 16, 2012: NanoString Initiates Second Clinical Validation Study For PAM50-Based Breast

Cancer Assay 705

9.5.158 May 15, 2012: OraSure‘s OraQuick In-Home HIV Test Receives Unanimous Positive

Recommendation From FDA Advisory Committee 706

9.5.159 May 15, 2012: Accelr8 And Denver Health Secure $2m Rapid Diagnostics Grant From

Department of Defense 707

9.5.160 May 15, 2012: Idaho Technology Receives FDA 510(k) Clearance For Expanded FilmArray

Respiratory Panel 707

9.5.161 May 14, 2012: EMD Millipore's Muse Cell Analyzer Wins Red Dot Design Award 2012 708

9.5.162 May 09, 2012: Sequenom Signs Agreement With Coventry Health Care National Network For

CMM MaterniT21 PLUS LDT 709

9.5.163 May 07, 2012: CardioDx To Present Results From Two Studies Evaluating Clinical Utility Of

Corus CAD Gene Expression Test For Obstructive Coronary Artery Disease 709

9.5.164 May 07, 2012: Ariosa Diagnostics Announces Nationwide Launch Of Harmony Prenatal Test

Through LabCorp 710

9.5.165 May 03, 2012: DNA Genotek Announces Recipients Of DNA Genotek Grant Program 710

9.5.166 May 02, 2012: Trovagene Announces Plans To Develop New Test For High Risk HPV Carrier

Screening From Urine 711

9.5.167 May 01, 2012: Singulex Adds Erenna Interleuken -17A/F To Suite Of TH17 Pathway

Immunoassay Kits 712

9.5.168 Apr 30, 2012: Siemens Receives CE Mark For New Urine Chemistry Analyzer 713

9.5.169 Apr 30, 2012: CardioDx Wins Edison Award For Corus CAD 714

9.5.170 Apr 26, 2012: New Clinical Endocrinology Guidelines Support Lp-PLA2 Measurement For Risk

Assessment Of Coronary Artery Disease: diaDexus 714

9.5.171 Apr 26, 2012: Luminex Receives CE Mark For xMAP NeoPlex4 Assay 715

9.5.172 Apr 25, 2012: Quest Diagnostics Announces C9orf72 Genetic Test For Lou Gehrig's Disease

716

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9.5.173 Apr 25, 2012: Idaho Technology's FilmArray RP Demonstrates Significant Workflow Benefit

And Pathogen Specificity 716

9.5.174 Apr 24, 2012: Life Technologies Installs Ion Proton Systems At BCM-HGSC Center, Texas 717

9.5.175 Apr 20, 2012: Quidel Receives CLIA Waiver For Sofia Analyzer And Sofia Influenza A+B FIA

718

9.5.176 Apr 19, 2012: IMDx To Present Development Of Fully Automated Molecular Test For Detection

Of Influenza A/B And RSV At 28th Annual Clinical Virology Symposium 718

9.5.177 Apr 19, 2012: Idaho Technology To Highlight Diagnostic FilmArray Respiratory Panel At 28th

Annual Clinical Virology Symposium 719

9.5.178 Apr 19, 2012: T2 Biosystems Announces Data Presentation On T2Hemostasis At 44th Annual

Oak Ridge Conference 719

9.5.179 Apr 18, 2012: Cytomedix Announces Multiple Poster Presentations On AutoloGel System At

SAWC Spring 2012 720

9.5.180 Apr 18, 2012: Chembio Reports Completion Of Enrollment In Pivotal Trial For DPP HIV 1/2

Assay 720

9.5.181 Apr 18, 2012: JS Genetics Launches XCAT-FX For Fragile X Syndrome 721

9.5.182 Apr 18, 2012: AspenBio To Present Results From Recently Completed 503-Patient Pilot Study

Of AppyScore At SAEM Annual Meeting 722

9.5.183 Apr 17, 2012: QIAGEN Receives FDA Clearance For Rotor-Gene Q MDx Instrument 722

9.5.184 Apr 17, 2012: Gold Standard Diagnostics Announces Global Launch Of New, Fully Automated

ELISA Platform ThunderBolt 723

9.5.185 Apr 16, 2012: MicroPhage Receives Additional FDA 510(k) Clearance For KeyPath

MRSA/MSSA Blood Culture Test-BT 723

9.5.186 Apr 10, 2012: GeneTex Launches Monoclonal Antibody To Detect CA IX Cancer Biomarker 724

9.5.187 Apr 05, 2012: Diatron Receives FDA 510(k) Clearance For Abacus 5 724

9.5.188 Apr 04, 2012: FDA Sets Date For Advisory Committee On Review Of OraQuick Rapid HIV-1/2

Test 725

9.5.189 Apr 02, 2012: CardioDx To Present At 11th Annual Needham Healthcare Conference 725

9.5.190 Mar 30, 2012: Transgenomic Presents Results From 448-Gene NuclearMitome Test In 78

Patients At 2012 Annual Meeting Of ACMG 725

9.5.191 Mar 29, 2012: Life Technologies Receives ‗red dot‘ Award For Ion Proton Sequencer 726

9.5.192 Mar 28, 2012: PositiveID Receives Nucleic Acids From CDC Influenza Division To Develop

Diagnostic Assay To Detect H5N1 Avian Flu 727

9.5.193 Mar 28, 2012: Ortho-Clinical Announces Availability Of Avioq HTLV-I/II Microelisa System

Assay 728

9.5.194 Mar 27, 2012: BD And FIND Extend Pricing Agreement To Reach HIV-Positive Patients In

India 728

9.5.195 Mar 27, 2012: Ambry Genetics Introduces First-Step Exome Sequencing Test 729

9.5.196 Mar 27, 2012: Avioq Receives FDA Approval For HTLV-I/II Microelisa System 729

9.5.197 Mar 26, 2012: Ariosa Diagnostics Announces Completion Of Laboratory-Developed Test Study

For Harmony Prenatal Test 730

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9.5.198 Mar 22, 2012: Quidel Receives FDA Clearance For Its Quidel Molecular Influenza A+B Assay

For Use With Cepheid SmartCycler 731

9.5.199 Mar 21, 2012: New Studies Demonstrate Clinical Utility And Validity Of CancerType ID

Molecular Classifier 731

9.5.200 Mar 21, 2012: Investigational Study May Help Researchers Develop Test That Predicts Risk Of

Imminent Heart Attacks 732

9.5.201 Mar 20, 2012: PositiveID Receives US Patent For Its Dragonfly Rapid MDx Cartridge-Based

Diagnostic System 733

9.5.202 Mar 19, 2012: diaDexus Highlights Findings From Two Outcomes Studies For Its PLAC Lp-

PLA(2) Activity Assay 733

9.5.203 Mar 19, 2012: Diagnostic BioSystems Launches First Automated IHC Multiplex Platform For

Anatomic Pathology 734

9.5.204 Mar 19, 2012: MagnaBioSciences Receives FDA 510(k) Clearance For MICT Instrument 734

9.5.205 Mar 15, 2012: Atherotech‘s VAP Cholesterol Test Helps Researchers To Study Dyslipidemia,

Assess Effectiveness Of New Anti-Flushing Agent 735

9.5.206 Mar 15, 2012: Quest Diagnostics Launches First Molecular Test For Kidney Organ Transplant

Rejection 735

9.5.207 Mar 15, 2012: Quest Diagnostics Launches Renal Monitoring Blood Test For Kidney Organ

Transplant Rejection 736

9.5.208 Mar 13, 2012: Maine Receives FDA Clearance For VALIDATE VIT D Calibration Verification /

Linearity Test Kit 737

9.5.209 Mar 13, 2012: Enzo Biochem‘s Clinical Laboratory Applies For NY State Health Department

Approval For First Assay Based On Its AmpiProbe Amplification Platform 738

9.5.210 Mar 09, 2012: Daxor Announces Filing Of Two Additional Patents For Updated Automated

Blood Analyzer 738

9.5.211 Mar 08, 2012: EKF Receives US Patent For HemoPoint H2 Cuvettes 739

9.5.212 Mar 07, 2012: Illumina Introduces TruSeq Amplicon-Cancer Panel For MiSeq System 740

9.5.213 Mar 06, 2012: Miraculins Outlines Details Of PreVu 510(k) FDA Clearance 740

9.5.214 Feb 28, 2012: Study Demonstrates AspenBio Pharma‘s AppyScore Multi-Marker Blood Test

Highly Predictive For Absence Of Acute Appendicitis In Children With Abdominal Pain 742

9.5.215 Feb 24, 2012: Natera To Present Update About Development, Commercialization Of Non-

Invasive Prenatal Diagnostic Test At Citi 2012 Global Health Care Conference 742

9.5.216 Feb 23, 2012: Abbott Collaborates With University of North Texas Science Center On Human

Identification Testing 743

9.5.217 Feb 16, 2012: Bioline Introduces New SensiFAST HRM Kit For Gene Mutations And SNP

Analysis 744

9.5.218 Feb 14, 2012: IrriMax Receives Supply Contract From Premier healthcare alliance For IrriSept

Wound Debridement And Cleansing System 744

9.5.219 Feb 14, 2012: Agilent Technologies Extends Target-Enrichment Platform To Desktop

Sequencers 745

9.5.220 Feb 13, 2012: Verinata Health Announces Presentation And Publication Of Top-Line Clinical

Validation Study Results For Its verifi Non-Invasive Prenatal Test 745

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9.5.221 Feb 06, 2012: Aria Diagnostics Announces Name Of New Non-Invasive Prenatal Assay -

Harmony Prenatal Test - And Publication Of Study On Specimen Transport 746

9.5.222 Feb 03, 2012: Natera To Disclose Details Of Non-Invasive Prenatal Diagnostic At Society for

Maternal-Fetal Medicine‘s 32nd Annual Meeting In Dallas 747

9.5.223 Feb 03, 2012: Siemens Automated Mycophenolic Acid Test On Dimension Systems Now

Available In US 747

9.5.224 Feb 02, 2012: Study Published In Genetics In Medicine Demonstrates Sequenom CMM

MaterniT21 Test Accurately Detects Two Additional Fetal Trisomies 748

9.5.225 Feb 01, 2012: Daxor Signs Trial Agreement With Shertech Pharmacy In South Carolina For

Blood Volume Analyzer-100 749

9.5.226 Feb 01, 2012: AspenBio Sets 2012 AppyScore Anticipated Milestones; Sees Pivotal Clinical

Trial For Appendicitis Test Beginning Mid-2012 749

9.5.227 Feb 01, 2012: Miraculins Receives Health Canada Approval To Market For PreVu POC Test

751

9.5.228 Jan 31, 2012: Biomerica Launches New Patented TPMT Test to Identify Individuals At Risk Of

Developing Severe Side Effects From Thiopurine Drugs 751

9.5.229 Jan 27, 2012: New Data Publication In AJOG Highlights Algorithm For Aria's Non-Invasive

Prenatal Assay 752

9.5.230 Jan 26, 2012: Aria Diagnostics Announces Publication Of Independent Study Of Its Non-

Invasive Prenatal Test In American Journal of Obstetrics & Gynecology 753

9.5.231 Jan 26, 2012: BioReference To Launch OnkoMatch Genotype Test Through Its GenPath

Oncology Laboratory 753

9.5.232 Jan 26, 2012: Study: VAP Comprehensive Cholesterol Test Improves Identification Of CIMT

Progression 754

9.5.233 Jan 25, 2012: Fenwal Receives New Regulatory Clearances For Amicus Separator And DXT

Relay Software 755

9.5.234 Jan 19, 2012: Ambry Genetics Reports Results From Clinical Diagnostic Exome Testing Of

Three Patients 756

9.5.235 Jan 17, 2012: Study: VAP Comprehensive Cholesterol Test Improves Outcomes, Reduces

Costs By 35% For Managed Care 756

9.5.236 Jan 11, 2012: Genetic Sudden Cardiac Death Screening Test On Horizon: GnuBIO 757

9.5.237 Jan 10, 2012: Life Technologies Unveils Benchtop Ion Proton Sequencer 758

9.5.238 Jan 10, 2012: Illumina Introduces HiSeq 2500 759

9.5.239 Jan 09, 2012: Aria Diagnostics Announces Publication Of First Peer-Reviewed Data For New

Non-Invasive Prenatal Test 760

10 Appendix 761

10.1 Definitions of Markets Covered in the Report 762

10.1.1 In Vitro Diagnostics 762

10.2 Research Methodology 773

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10.3 Secondary Research 773

10.4 Primary Research 774

10.5 Models 774

10.6 Forecasts 775

10.7 Expert Panels 775

10.8 GlobalData Consulting 775

10.9 Currency Conversion 775

10.10 Disclaimer 775

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1.1 List of Tables

Table 1: In Vitro Diagnostics, Cross Country Comparison, Revenue ($m),USD Constant, 2004-2018 ........................... 44

Table 2: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018 ................................... 46

Table 3: In Vitro Diagnostics, North America, Cross-Category Analysis, 2004-2018 .......................................................... 48

Table 4: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .................... 50

Table 5: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, Forecast, 2011-2018.................. 52

Table 6: In Vitro Diagnostics, North America, Company share by Revenue ($m), USD Constant, 2010-2011 .............. 54

Table 7: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 ..................................... 56

Table 8: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ..................... 58

Table 9: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ................... 60

Table 10: Clinical Chemistry, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............. 61

Table 11: Genetic Testing, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ................. 61

Table 12: Haematology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ..................... 62

Table 13: Histology And Cytology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ... 62

Table 14: Immuno Chemistry, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ........... 63

Table 15: Infectious Immunology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ..... 63

Table 16: Microbiology Culture, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ........ 64

Table 17: In Vitro Diagnostics, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ............. 66

Table 18: Clinical Chemistry, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ................ 67

Table 19: Genetic Testing, United States, Company Share by Revenue ($m), USD Constant, 2010-2011.................... 69

Table 20: Haematology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ........................ 71

Table 21: Immuno Chemistry, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 .............. 73

Table 22: Infectious Immunology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ........ 75

Table 23: Microbiology Culture, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ........... 77

Table 24: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, 2004-2018 ............................................ 79

Table 25: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ............................. 81

Table 26: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ........................... 83

Table 27: Clinical Chemistry, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ....................... 84

Table 28: Genetic Testing, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011........................... 84

Table 29: Haematology, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............................... 85

Table 30: Histology And Cytology, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............. 85

Table 31: Immuno Chemistry, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ..................... 86

Table 32: Infectious Immunology, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............... 86

Table 33: Microbiology Culture, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 .................. 87

Table 34: In Vitro Diagnostics, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ....................... 89

Table 35: Clinical Chemistry, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ......................... 91

Table 36: Genetic Testing, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ............................. 93

Table 37: Haematology, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 .................................. 95

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Table 38: Histology And Cytology, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ................ 97

Table 39: Immuno Chemistry, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ........................ 99

Table 40: Infectious Immunology, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011................ 101

Table 41: Microbiology Culture, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ................... 103

Table 42: Clinical Chemisty Market Pipeline Products ........................................................................................................... 119

Table 43: Immuno Chemistry Market Pipeline Products ......................................................................................................... 126

Table 44: Haematology Market Pipeline Products .................................................................................................................. 137

Table 45: Infectious Immunology Market Pipeline Products .................................................................................................. 139

Table 46: Microbiology Culture Market Pipeline Products ...................................................................................................... 146

Table 47: Histology And Cytology Market Pipeline Products ................................................................................................. 148

Table 48: Genetic Testing Market Pipeline Products .............................................................................................................. 149

Table 49: SQI Diagnostics Plans For Sale Of The Company ............................................................................................... 154

Table 50: Sparton Completes Acquisition Of Onyx EMS, Contract Manufacturing Services Provider, For $43 Million .................................................................................................................................................................................................... 155

Table 51: ERBA Diagnostics Acquires Drew Scientific, Maker Of Analytical Instruments And Reagents, For $6.5 Million ......................................................................................................................................................................................... 157

Table 52: Measurement Specialties Acquires Cambridge Technologies And Resistance Temperature Detector Company For $18.8 Million ..................................................................................................................................................... 159

Table 53: Atossa Genetics Acquires Acueity Healthcare, Diagnostic Device Provider ..................................................... 160

Table 54: AccelPath Acquires DigiPath Solutions For $2.4 Million ...................................................................................... 161

Table 55: Danaher Completes Acquisition Of 91.6% Stake In Iris International, Diagnostic Test Maker, For $324 Million ......................................................................................................................................................................................... 162

Table 56: Charles River Labs Acquires Accugenix, Provider Of Microbe Identification Services, For $17 Million ....... 164

Table 57: Leica Biosystems Completes Acquisition Of Aperio Technologies .................................................................... 166

Table 58: Metabolon Acquires Lipomics Technologies, Diagnostics Company ................................................................. 169

Table 59: Waters Acquires Blue Reference, Maker Of Application Scientific Databases, For $14 Million ................... 171

Table 60: Life Technologies Acquires Pinpoint Genomics, Molecular Diagnostics Company ......................................... 172

Table 61: Thermo Fisher Scientific Completes Acquisition Of One Lambda, Transplant Diagnostics Company, For $925 Million ............................................................................................................................................................................... 173

Table 62: Life Technologies Acquires Navigenics .................................................................................................................. 175

Table 63: Genova Diagnostics Acquires Metametrix, Clinical Laboratory .......................................................................... 177

Table 64: 23andMe Acquires CureTogether, Healthcare IT Company ............................................................................... 178

Table 65: Luminex To Acquire GenturaDx, Molecular Diagnostics Company, For $50 Million ....................................... 179

Table 66: Systagenix Acquires O2 Insights ............................................................................................................................. 181

Table 67: Maxxam Analytics Acquires Becquerel Labs, Provider Of Testing Services .................................................... 182

Table 68: LabCorp Completes Acquisition Of Medtox Scientific For $241 Million ............................................................. 183

Table 69: Flagship Biosciences Acquires Ihctech, Provider Of Research Immunohistochemistry And Histology Services ..................................................................................................................................................................................... 185

Table 70: Halo Healthcare Acquires NeoMatrix, Maker Of Diagnostic Equipments .......................................................... 186

Table 71: Pacepartners To Acquire Vivione BioSciences ..................................................................................................... 187

Table 72: Qiagen Acquires AmniSure International, Manufacturer Of Non Invasive Test Solutions .............................. 188

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Table 73: Hologic Completes Acquisition Of Gen-Probe For $3.7 Billion ........................................................................... 189

Table 74: Haemonetics To Acquire Hemerus Medical, Provider Of Leukoreduction Technologies, For $27 Million .... 192

Table 75: IntegenX Acquires SV, Provider Of DNA Identification Consumable Products, From GE Healthcare Bio-Sciences .................................................................................................................................................................................... 194

Table 76: Beckman Coulter Acquires Blue Ocean Biomedical From Npe Systems .......................................................... 195

Table 77: Abcam Completes Acquisition Of Epitomics, Rabbit Monoclonal Antibodies Provider, For $155 Million ..... 196

Table 78: Ontario Genomics Institute Acquires Minority Stake In RNA Diagnostics For $0.1 Million ............................. 198

Table 79: PhotoVoltaic Solar Cells Acquires MetaStat, Life Science Company ................................................................ 199

Table 80: Alere To Acquire eScreen, Provider Of Health Testing Products And Services, For Up To $340 Million ..... 200

Table 81: Bode Technology Group Acquires Provider Of DNA Analysis Testing Services, Chromosomal Labs ......... 202

Table 82: Signal Genetics To Acquire Molecular Diagnostics Company, ChipDX ............................................................ 203

Table 83: Multiple Myeloma Research Foundation Enters Into Co-Development Agreement With GenoSpace .......... 204

Table 84: Empire Genomics Enters Into Licensing Agreement With Emory University For Genomic Biomarkers ....... 205

Table 85: NanoPass Technologies Enters Into Licensing Agreement With Janssen Pharma For MicronJet ................ 206

Table 86: Cisbio Bioassays Enters Into Distribution Agreement With BellBrook Labs For Transcreener Epigen Methyltransferase Assay ......................................................................................................................................................... 207

Table 87: BioView Enters Into Agreement With Abbott To Develop Automated Cancer Screening System ................. 209

Table 88: Institute of Microelectronics Enters Into Co-Development Agreement With SFC Fluidics .............................. 210

Table 89: HTG Molecular Diagnostics Enters Into Licensing Agreement With Centre of Excellence for Prevention of Organ Failure For COPD Prognostic Test ............................................................................................................................ 211

Table 90: Pressure BioSciences Enters Into Co-Marketing Agreement With Constant Systems For High Pressure Technologies ............................................................................................................................................................................ 212

Table 91: CML HealthCare Enters Into Licensing Agreement With Mitomics For Prostate Cancer Test ....................... 214

Table 92: bioMerieux Enters Into Licensing Agreement With Quanterix For Simoa Technology .................................... 215

Table 93: DioGenix Enters Into Agreement With Fast Forward To Develop New Blood Test For Multiple Sclerosis .. 217

Table 94: GNS Healthcare Enters Into Agreement With Dana-Farber Cancer Institute and Mount Sinai School of Medicine .................................................................................................................................................................................... 219

Table 95: Crown Bioscience Enters Into Co-Development Agreement With Horizon Discovery ..................................... 221

Table 96: CombiMatrix Enters Into Co-Marketing Agreement With Pathology For Prenatal Tests ................................. 222

Table 97: Clinical Genomics Enters Into Licensing Agreement With Quest Diagnostics For Colon Cancer Markers .. 223

Table 98: Abaxis Enters Into Distribution Agreement With Abbott Point of Care For Piccolo Blood Chemistry System .................................................................................................................................................................................................... 224

Table 99: Affinity Biosensors Enters Into Distribution Agreement With Malvern Instruments For Archimedes Particle Metrology System .................................................................................................................................................................... 226

Table 100: Malvern Instruments Enters Into Co-Marketing Agreement With Affinity Biosensors For Archimedes Particle Metrology System ...................................................................................................................................................... 227

Table 101: Exosome Diagnostics Enters Into Co-Development Agreement With Promega For Urine Clinical Sample Concentrator Kit ....................................................................................................................................................................... 228

Table 102: Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ ....................................... 229

Table 103: Ezose Enters Into Co-Development Agreement With Fast Forward For Multiple Sclerosis Biomarkers .... 230

Table 104: BioDot Enters Into Co-Marketing Agreement With JOT Automation ................................................................ 231

Table 105: Sequella Enters Into Licensing Agreement With LabCorp For B-Smart Technology .................................... 232

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Table 106: LifeTech Scientific, DiNova Venture Partners, Themes Investment Partners And Broncus Technologies Partner To Form Broncus Medical ......................................................................................................................................... 233

Table 107: Van Andel Institute Enters Into Co-Development Agreement With Emory University ................................... 235

Table 108: Merck Serono Enters Into Co-Development Agreement With Auxogyn For Early Embryo Viability Assessment Test ...................................................................................................................................................................... 236

Table 109: PGXL Labs Enters Into Joint Venture Agreement With Essential Molecular Testing .................................... 237

Table 110: Broad Institute Enters Into Distribution Agreement With Appistry For Genome Analysis Toolkit ................ 238

Table 111: Thermo Fisher Enters Into Co-Development Agreement With Immundiagnostik ........................................... 239

Table 112: Sage Labs Enters Into Agreement With Ekam Imaging To Develop Imaging Assays .................................. 240

Table 113: Bruker Enters Into An Agreement With Nextval For High-throughput Screening Technology ..................... 241

Table 114: BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays ............... 242

Table 115: RainDance Technologies Enters Into Co-Development Agreement With Integrated DNA Technologies For Digital PCR ............................................................................................................................................................................... 243

Table 116: Amarantus BioSciences Enters Into Option For Licensing Agreement With Memory Dx For LymPro Blood Test ............................................................................................................................................................................................ 245

Table 117: Iverson Genetic Diagnostics Enters Into Licensing Agreement With Johns Hopkins University School For Molecular Diagnostic Tests .................................................................................................................................................... 246

Table 118: Rosetta Genomics Amends Co-Marketing Agreement With Precision Therapeutics For miRview mets2 Assays ....................................................................................................................................................................................... 247

Table 119: Mitomics Enters Into Co-Marketing Agreement With LabCorp For Prostate Core Mitomic Test ................. 248

Table 120: Trillium Diagnostics Enters Into Licensing Agreement With Leukocare For Sepsis Dx ................................ 250

Table 121: Foundation Medicine Enters Into Agreement With Eisai For Genomic Profiling And Diagnostic Discovery .................................................................................................................................................................................................... 251

Table 122: Vela Diagnostics Enters Into Licensing Agreement With Life Technologies ................................................... 252

Table 123: Augurex Life Sciences Enters Into Licensing Agreement With Quest Diagnostics For 14-3-3n Biomarker .................................................................................................................................................................................................... 253

Table 124: CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital Microscopy Hematology Solutions ............................................................................................................................................................. 254

Table 125: Ingenuity Systems Enters Into Co-Development Agreement With Life Technologies For Diagnostic Solutions .................................................................................................................................................................................... 256

Table 126: Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx Test ..... 258

Table 127: Genia Technologies Enters Into Co-Development Agreement With Columbia University And Harvard University................................................................................................................................................................................... 260

Table 128: NextBio Enters Into Agreement With Winship Cancer Institute of Emory University For Myeloma Biomarkers ................................................................................................................................................................................ 262

Table 129: Proof Centre Enters Into Co-Development Agreement With AllerGen For Allergy Biomarkers ................... 263

Table 130: Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology ......................... 264

Table 131: Atossa Enters Into Co-Marketing Agreement With Diagnostics Test Group For MASCT System .............. 265

Table 132: Genalyte Partners Scienion To Provide Sciflexarrayer Dispensers For Maverick Detection Platform ........ 266

Table 133: CML HealthCare Enters Into Agreement With MaRS Innovation ..................................................................... 267

Table 134: Life Technologies Enters Into Agreement With Bristol-Myers Squibb For Companion Diagnostics Development ............................................................................................................................................................................. 268

Table 135: Agilent Technologies Enters Into Co-Marketing Agreement With Molecular Discovery ................................ 269

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Table 136: Agilent Technologies Enters Into Co-Marketing Agreement With MRM Proteomics ..................................... 270

Table 137: Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For Mesothelioma Test .................................................................................................................................................................. 271

Table 138: Illumina Enters Into Technology Integration Agreement With Partners HealthCare System ........................ 272

Table 139: Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array Products .... 274

Table 140: ImaginAb Enters Into Co-Development Agreement With MacroGenics .......................................................... 275

Table 141: BellBrook Labs Enters Into Co-Development Agreement With Reaction Biology .......................................... 276

Table 142: GVK Biosciences Enters Into Licensing Agreement With National Cancer Institute For GOBIOM Database .................................................................................................................................................................................................... 277

Table 143: GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina ................... 278

Table 144: Perkinelmer Enters Into Co-Development Agreement With Massachusetts General Hospital .................... 279

Table 145: Affymetrix Enters Into Co-Development Agreement With Pathgen Dx ............................................................ 281

Table 146: Axela Enters Into Co-Marketing Agreement With OvaGene Oncology ........................................................... 282

Table 147: University of Michigan Enters Into Joint Venture Agreement With International Genomics Consortium .... 283

Table 148: Regulus Therapeutics Enters Into An Agreement With Biogen Idec For Biomarkers.................................... 284

Table 149: Curetis Enters Into Licensing Agreement With Cempra For Unyvero .............................................................. 285

Table 150: Foundation Medicine Enters Into Co-Development Agreement With Clovis Oncology ................................. 286

Table 151: Saladax Biomedical Expands Co-Development Agreement With Bristol-Myers Squibb ............................... 287

Table 152: Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test ............. 288

Table 153: Waters Enters Into Co-Development Agreement With Nonlinear Dynamics .................................................. 289

Table 154: Affymetrix Expands Licensing Agreement With Siemens Healthcare For Branched DNA Technology ...... 290

Table 155: Molecular Targeting Technologies Enters Into Licensing Agreement With Medical College of Wisconsin For 99mTc-HYNIC-Duramycin ............................................................................................................................................... 291

Table 156: Rosetta Genomics Enters Into Co-Marketing Agreement With Precision Therapeutics For miRview mets2 Assays ....................................................................................................................................................................................... 292

Table 157: Bio-Rad Labs Enters Into Distribution Agreement With Myriad RBM For Multiplex Biomarker Kits ............ 294

Table 158: Gen-Probe Enters Into Co-Marketing Agreement With Life Technologies ...................................................... 295

Table 159: OriGene Technologies Enters Into Co-Development Agreement With Centre of Excellence for Prevention of Organ Failure ....................................................................................................................................................................... 296

Table 160: Siemens Healthcare Diagnostics Enters Into Distribution Agreement With Sysmex .................................... 297

Table 161: IRIS International Enters Into Distribution Agreement With Alifax .................................................................... 298

Table 162: EKF Diagnostics Enters Into Licensing Agreement With Joslin Diabetes Center .......................................... 299

Table 163: SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor ................ 301

Table 164: Clovis Oncology Enters Into Co-Development Agreement With Array BioPharma........................................ 302

Table 165: RS Medical Enters Into Distribution Agreement With Harvest Technologies .................................................. 303

Table 166: Immuno-Biological Labs Enters Into Licensing Agreement With IBL International ........................................ 304

Table 167: Sandia National Labs Plans To Enter Into Licensing Agreement For SpinDx, Medical Diagnostic Tool .... 305

Table 168: HTG Molecular Diagnostics Enters Into Licensing Agreement With Merck For Breast Cancer Marker Patent Portfolio ......................................................................................................................................................................... 306

Table 169: Genisphere Enters Into Co-Development Agreement With Lankenau Institute for Medical Research ....... 307

Table 170: WaferGen Biosystems Enters Into Agreement With Integrated DNA Technologies ...................................... 308

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Table 171: Pacgen Enters Into Distribution Agreement With Arise Biotech For Pipettes ................................................. 309

Table 172: BioView Enters Into Co-Development Agreement With ScreenCell For Circulating Tumor Cell Analysis Technology ............................................................................................................................................................................... 310

Table 173: MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test ................................ 311

Table 174: Fluxion Biosciences Enters Into Co-Development Agreement With Stanford University School of Medicine .................................................................................................................................................................................................... 313

Table 175: Merrimack Pharma Enters Into Co-Development Agreement With Cancer Treatment Centers of America .................................................................................................................................................................................................... 314

Table 176: Phenomenome Discoveries Enters Into Licensing Agreement With Polymedco For Cancer Diagnostic Test .................................................................................................................................................................................................... 315

Table 177: PlexPress Enters Into Technology Integration Agreement With Phalanx Biotech ......................................... 316

Table 178: PrimeraDx Enters Into Co-Development Agreement With Eli Lilly ................................................................... 317

Table 179: Kreatech Diagnostics Enters Into Co-Development Agreement With Oridis Biomarkers For DNA-FISH Assays ....................................................................................................................................................................................... 319

Table 180: Stratos Enters Into Co- Development Agreement With nanoMR ...................................................................... 320

Table 181: Guided Therapeutics Extends Licensing And Co-Development Agreement With Konica Minolta .............. 321

Table 182: CogState Enters Into Licensing Agreement With Merck Canada For Cognition Test ................................... 322

Table 183: Berg Pharma Enters Into Co-Development Agreement With Parkinson's Institute ........................................ 323

Table 184: Courtagen Life Sciences Enters Into Licensing Agreement With Scienion For sciFlexArrayer Technology .................................................................................................................................................................................................... 324

Table 185: NicOx Enters Into Licensing Agreement With Rapid Pathogen Screening For AdenoPlus .......................... 325

Table 186: Leica Microsystems Enters Into Integration Agreement With Indica Labs ...................................................... 327

Table 187: Prolias Technologies Enters Into Licensing Agreement With Cornell University For microRNA Diagnostic Portfolio ..................................................................................................................................................................................... 328

Table 188: Epigenomics Enters Into Licensing Agreement With Companion Dx Reference Lab For Septin9 Biomaker .................................................................................................................................................................................................... 329

Table 189: Immunexpress Enters Into Licensing Agreement With Debiopharm And Biocartis ....................................... 330

Table 190: Asuragen Enters Into Licensing Agreement With Becton, Dickinson .............................................................. 332

Table 191: Omega Diagnostics Enters Into Licensing Agreement With Burnet Institute For CD4 POC Test ................ 333

Table 192: KineMed Enters Into Co-Development Agreement With GlaxoSmithKline ..................................................... 334

Table 193: Bruker Enters Into Research Agreement With Special Bacteriology Reference Laboratory ........................ 335

Table 194: Bruker Enters Into Research Agreement With JMI Laboratories ...................................................................... 337

Table 195: RayBiotech Enters Into Agreement With Oslo University Hospital And University of Oslo........................... 338

Table 196: Vela Diagnostics Enters Into Co-Development Agreement With Eppendorf .................................................. 340

Table 197: One Lambda Enters Into Co-Marketing Agreement With CellTrend ................................................................ 341

Table 198: ImaginAb Extends Licensing Agreement With Bzl Biologics For Imaging Prostate Specific Membrane Antigen ...................................................................................................................................................................................... 342

Table 199: Foundation Medicine Extends Co-Development Agreement With Novartis .................................................... 343

Table 200: Affymetrix Enters Into Co-Development Agreement With Massachusetts General Hospital For New Oncology Biomarker Tests ..................................................................................................................................................... 344

Table 201: Fluxion Bioscience Enters Into Technology Integration Agreement With Rubicon Genomics ..................... 345

Table 202: Exosome Diagnostics Enters Into Technology Integration Agreement With Life Technologies ................... 346

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Table 203: HTG Molecular Diagnostics Enters Into Co-Marketing Agreement With John Wayne Cancer Institute ..... 347

Table 204: Clarient Diagnostic Services Enters Into Licensing Agreement With Insight Genetics For ALK Cancer Biomarker .................................................................................................................................................................................. 348

Table 205: Ventana Medical Enters Into Licensing Agreement With German Cancer Research Center And University Hospital Heidelberg For BRAF V600E .................................................................................................................................. 349

Table 206: Affymetrix Enters Into Technology Integration Agreement With Leica Microsystems ................................... 351

Table 207: Radisens Diagnostics Enters Into Co-Development Agreement With Beckman Coulter For HDR Detection Technology ............................................................................................................................................................................... 353

Table 208: XDx Enters Into Agreement With LabCorp To Develop Lupus Flare Predictor Test ..................................... 354

Table 209: Prosolia Enters Into Licensing Agreement With AB Sciex For ORNL Analytical Technology ...................... 356

Table 210: Ventana Medical Enters Into Licensing Agreement With Gen-Probe For IP Of ERG Marker ...................... 357

Table 211: Affymetrix Enters Into Distribution Agreement With ScreenCell For Circulating Tumor Cell Technology .. 359

Table 212: Exact Sciences Expands Licensing Agreement With Mayo Clinic ................................................................... 360

Table 213: Hycor Biomedical Enters Into Distribution Agreement With Roche For KOVA ............................................... 361

Table 214: Dako Announces Licensing Agreement With Van Andel Research Institute For Cancer Diagnostic Tool . 362

Table 215: MicroFluidic Systems Enters Into Co-Development Agreement With University of Nevada ........................ 363

Table 216: KineMed Enters Into Co-Development Agreement With CHDI Foundation .................................................... 364

Table 217: ZyGem Enters Into Technology Integration Agreement With Quanta BioSciences ....................................... 365

Table 218: Pressure BioSciences Enters Into Co-Development Agreement With Leap Technologies, Vici Valco Instruments And Sage-N Research ....................................................................................................................................... 366

Table 219: Islet Sciences Enters Into Licensing Agreement With Yale University For Early Beta Cell Destruction and Diabetes Diagnostic ................................................................................................................................................................. 368

Table 220: Genomic Health Enters Into Co-Development Agreement With OncoMed Pharma ...................................... 369

Table 221: Applied Microarrays Enters Into Co-Development Agreement With Sensovation For FlexiPlex Array System ....................................................................................................................................................................................... 370

Table 222: Cardinal Health Enters Into Distribution Agreement With Qiagen For Molecular Diagnostic Products....... 371

Table 223: MetaStat Enters Into Licensing Agreement With Albert Einstein College of Medicine For Metastatic Cell Technology Patents ................................................................................................................................................................. 372

Table 224: Genome Diagnostics Enters Into Co-Marketing Agreement With Qiagen For LongRange PCR Kit ........... 373

Table 225: Biofortuna Extends Co-Marketing Agreement With Abbott Labs For SSPGo ................................................ 374

Table 226: Pressure BioSciences Enters Into Licensing Agreement With Target Discovery For Pressure Cycling Technology ............................................................................................................................................................................... 375

Table 227: Ezose Sciences Enters Into Co-Development Agreement With Hirosaki University For New Cancer Biomarkers ................................................................................................................................................................................ 377

Table 228: LipoScience Enters Into Licensing Agreement With Cleveland Clinic ............................................................. 378

Table 229: GE Healthcare Enters Into Co-Development Agreement With NXT2B For Compact Cyclotron And PET Tracer System .......................................................................................................................................................................... 379

Table 230: Miraculins Enters Into Co-Marketing Agreement With Pear Healthcare Solutions For PreVu ..................... 380

Table 231: Abbott Enters Into Licensing Agreement With Stanford University For Prostate Cancer Biomarkers......... 381

Table 232: Metabolon Enters Into Co-Development Agreement With Takeda Pharma.................................................... 383

Table 233: Penn State Hershey Enters Into Co-Development Agreement With Serametrix ............................................ 384

Table 234: Sysmex Extends Distribution Agreement With Roche ....................................................................................... 385

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Table 235: Seattle Genetics And Millennium Pharma Enter Into Co-Development Agreement With Ventana Medical Systems ..................................................................................................................................................................................... 387

Table 236: Rubicon Genomics Enters Into Technology Integration Agreement With Kreatech Diagnostics ................. 389

Table 237: NexDx Enters Into Licensing Agreement With University of California For Epigenetic Biomarkers ............ 390

Table 238: Elchrom Scientific Enters Into Technology Integration Agreement With Biotium ........................................... 391

Table 239: RayBiotech Enters Into Co-Marketing Agreement With Innopsys .................................................................... 392

Table 240: BGN Technologies Enters Into Licensing Agreement With Lauren Sciences For V-Smart Technology .... 393

Table 241: Stellar Biotechnologies Enters Into Option Licensing Agreement With University of Guelph For Clostridium Difficile Technology .................................................................................................................................................................. 394

Table 242: Shimadzu Scientific Instruments Enters Into Joint Venture Agreement With University of Texas ............... 395

Table 243: Centre of Excellence for Prevention of Organ Failure Enters Into Co-Development Agreement With Adiga Life Sciences For Proteomic And Genomic Biomarkers .................................................................................................... 396

Table 244: Ridge Diagnostics Enters Into Licensing Agreement With Ameritox For MDDScore .................................... 397

Table 245: Bio-Rad Labs Extends Distribution Agreement With Luminex For MAGPIX .................................................. 398

Table 246: LabCorp Enters Into Licensing Agreement With OPKO Health For Alzheimer's Diagnostic Technology .. 400

Table 247: Accuray Enters Into Co-Development Agreement With University of Heidelberg .......................................... 402

Table 248: HTG Molecular Diagnostics Enters Into Co-Development Agreement With sanofi-aventis .......................... 403

Table 249: GenMark Diagnostics Enters Into Co-Development Agreement With Advanced Liquid Logic For Integrated Diagnostic Platform .................................................................................................................................................................. 404

Table 250: PerkinElmer Enters Into Licensing Agreement With GenMark Diagnostics For Microfluidics Patent Portfolio .................................................................................................................................................................................................... 406

Table 251: Bristol-Myers Squibb Enters Into Co-Development Agreement With Meso Scale ......................................... 408

Table 252: Applied BioCode Enters Into Licensing Agreement With Douglas Scientific For Barcoded Magnetic Beads Technology ............................................................................................................................................................................... 409

Table 253: Molecular Response Enters Into Co-Marketing Agreement With Transparent ............................................... 410

Table 254: IBM Enters Into Co-Development Agreement With Memorial Sloan-Kettering Cancer Center .................... 411

Table 255: QuantiScientifics Enters Into Co-Marketing Agreement With BioDot For A2 MicroArray System ............... 412

Table 256: INOVA Diagnostics Enters Into Licensing Agreement With AmberGen And Massachusetts General Hospital For Two Autoantigen Biomarkers ........................................................................................................................... 413

Table 257: Waters Enters Into Co-Marketing Agreement With Protea Biosciences Group For LASEI DP-1000 .......... 415

Table 258: Devicor Medical Products Enters Into Co-Marketing Agreement With Carbon Medical Technologies ....... 416

Table 259: Diomics Enters Into Licensing Agreement With University of Arizona For DNA Collection Technology .... 417

Table 260: Sage-N Research Enters Into Technology Integration Agreement With IO Informatics ................................ 418

Table 261: Mayo Medical Labs Enters Into Licensing Agreement With A&G Pharma For Progranulin Blood Test ..... 419

Table 262: Abbott Enters Into Co-Development Agreement With Genetics Lab For Molecular Assay Development .. 420

Table 263: Avedro Enters Into Option Agreement With Cleveland Clinic To License Intellectual Property Assets ...... 421

Table 264: GE Global Research Enters Into Co-Development Agreement With InDevR ................................................. 422

Table 265: Roche Enters Into Licensing Agreement With Life Technologies For PCR Technology ............................... 423

Table 266: Vital Diagnostics Enters Into Distribution Agreement With Cardinal Health .................................................... 424

Table 267: Dako Enters Into Co-Development Agreement With Amgen ............................................................................ 425

Table 268: Iverson Genetic Diagnostics Enters Into Co-Development Agreement With Vanderbilt University ............. 426

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Table 269: RedHill Biopharma Enters Into Co-Development Agreement With Quest Diagnostics To Develop MAP Test For Crohn's Disease ................................................................................................................................................................ 427

Table 270: Thermo Fisher Scientific Extends Licensing Agreement With Wako Pure Chemical Industries .................. 428

Table 271: Dolomite Centre Enters Into Co-Development Agreement With GigaGen ...................................................... 429

Table 272: Mitomics Enters Into Co-Marketing Agreement With LabMD For Prostate Core Mitomic Test .................... 430

Table 273: Fresh Start Private Management Enters Into Licensing Agreement With Glacier ......................................... 431

Table 274: IRIS Sample Processing Enters Into Distribution Agreement With Fisher HealthCare ................................. 432

Table 275: Courtagen Life Sciences Enters Into Co-Development Agreement With Tetracore ...................................... 433

Table 276: Quanterix, Beth Israel Deaconess And Forsyth Institute Enter Into Partnership To Develop Tuberculosis Test ............................................................................................................................................................................................ 434

Table 277: Avesthagen Enters Into Co-Development Agreement With CosmosID ........................................................... 436

Table 278: Siemens Healthcare Diagnostics Enters Into Co-Development Agreement With ViiV Healthcare .............. 437

Table 279: Siemens Healthcare Diagnostics Enters Into Co-Development Agreement With Tocagen .......................... 439

Table 280: Brooks Life Science Enters Into Licensing Agreement With The Scripps Research Institute ...................... 441

Table 281: SDIX Enters Into Licensing Agreement With BD Diagnostic ............................................................................. 443

Table 282: Thermo Fisher Scientific Enters Into Distribution Agreement With BellBrook Labs ....................................... 444

Table 283: DuPont Enters Into Co-Development Agreement With OligoCo ....................................................................... 445

Table 284: Genzyme Enters Into Co-Marketing Agreement With Veracyte ....................................................................... 447

Table 285: Boulder Diagnostics Enters Into Licensing Agreement With Portland State University ................................ 448

Table 286: Ventana Medical Systems Enters Into Co-Development Agreement With Bayer Pharma ........................... 449

Table 287: Pressure BioSciences Enters Into Co-Marketing Agreement With Digilab ..................................................... 451

Table 288: Agilent Technologies Enters Into Co-Development Agreement With Integrated Diagnostics ...................... 453

Table 289: Ventana Medical Systems Enters Into Co-Development Agreement With Pfizer .......................................... 454

Table 290: Ventana Medical Systems Enters Into Licensing Agreement With Cell Signaling Technology .................... 456

Table 291: Dako Enters Into Co-Development Agreement With Amgen ............................................................................ 458

Table 292: Foundation Medicine Enters Into Co-Development Agreement With Sanofi For Genetic Biomarkers And Potential Diagnostics ............................................................................................................................................................... 459

Table 293: University Of North Dakota Enters Into Licensing Agreement With NeoMatrix .............................................. 460

Table 294: Amorfix Life Sciences Enters Into Licensing Agreement With JSW-Lifesciences .......................................... 461

Table 295: Syndax Pharma Enters Into Co-Development Agreement With Ventana Medical Systems ........................ 462

Table 296: ZyGEM Enters Into Co-Development Agreement With USAMRIID ................................................................. 464

Table 297: AEterna Zentaris Enters Into Co-Development Agreement With Ventana Medical Systems ....................... 465

Table 298: Boulder Diagnostics Enters Into Licensing Agreement With RUNMC ............................................................. 467

Table 299: HistoRx Enters Into Licensing Agreement With Yale University ....................................................................... 468

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1.2 List of Figures

Figure 1: In Vitro Diagnostics, Cross Country Comparison, Revenue ($m), USD Constant, 2004-2018 ......................... 44

Figure 2: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018 .................................. 45

Figure 3: In Vitro Diagnostics, North America, Cross-Category Analysis, 2004-2018 ........................................................ 47

Figure 4: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .................. 49

Figure 5: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ................ 51

Figure 6: In Vitro Diagnostics, North America, Company share (%), 2011 ........................................................................... 53

Figure 7: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 ................................... 55

Figure 8: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .................... 57

Figure 9: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 .................. 59

Figure 10: In Vitro Diagnostics, United States, Company Share (%), 2011.......................................................................... 65

Figure 11: Clinical Chemistry, United States, Company Share (%), 2011 ............................................................................ 67

Figure 12: Genetic Testing, United States, Company Share (%), 2011 ................................................................................ 68

Figure 13: Haematology, United States, Company Share (%), 2011 .................................................................................... 70

Figure 14: Immuno Chemistry, United States, Company Share (%), 2011 .......................................................................... 72

Figure 15: Infectious Immunology, United States, Company Share (%), 2011 .................................................................... 74

Figure 16: Microbiology Culture, United States, Company Share (%), 2011........................................................................ 76

Figure 17: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, 2004-2018 ........................................... 78

Figure 18: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ............................ 80

Figure 19: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ......................... 82

Figure 20: In Vitro Diagnostics, Canada, Company Share (%), 2011 ................................................................................... 88

Figure 21: Clinical Chemistry, Canada, Company Share (%), 2011 ...................................................................................... 90

Figure 22: Genetic Testing, Canada, Company Share (%), 2011 .......................................................................................... 92

Figure 23: Haematology, Canada, Company Share (%), 2011 .............................................................................................. 94

Figure 24: Histology And Cytology, Canada, Company Share (%), 2011 ............................................................................. 96

Figure 25: Immuno Chemistry, Canada, Company Share (%), 2011 .................................................................................... 98

Figure 26: Infectious Immunology, Canada, Company Share (%), 2011 ............................................................................ 100

Figure 27: Microbiology Culture, Canada, Company Share (%), 2011 ............................................................................... 102

Figure 28: Siemens Healthcare, Company Share (%), North America In Vitro Diagnostics Market, 2011 .................... 104

Figure 29: Abbott Laboratories, Company Share (%),North America In Vitro Diagnostics Market, 2011 ...................... 105

Figure 30: F. Hoffmann-La Roche Ltd., Company Share (%),North America In Vitro Diagnostics Market, 2011 ......... 106

Figure 31: F. Hoffmann-La Roche Ltd., Company Share (%),North America In Vitro Diagnostics Market, 2011 ......... 107

Figure 32: Ortho-Clinical Diagnostics Inc., Company Share (%),North America In Vitro Diagnostics Market, 2011 .... 108

Figure 33: Alere Inc, Company Share (%),North America In Vitro Diagnostics Market, 2011 ......................................... 109

SAMPLE

Introduction




2 Introduction

GlobalData‘s medical equipment market reports are ideal guide for anyone wishing to understand

their market better in terms of revenue, distribution share and company share.

2.1 What is This Report About?

North America diagnostic imaging report provides an overview and the following information:

1. Comprehensive data related to the market revenue, distribution share and company share

2. Global corporate-level profiles of key companies operating in the diagnostic imaging

market in North America. The profile includes a brief overview of the company. The

selection of the companies is based on their operational presence in North America. This

includes key multinationals as well as key local players.

3. A list of key products under development by different companies. The selection of this list

is based on the territory in which these products are being clinically investigated.

Note: ―North America;‖ comprises the following countries – United States and Canada.

SAMPLE

North America In Vitro Diagnostics




3 In Vitro Diagnostics in North America

3.1 In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018

Figure 1: In Vitro Diagnostics, Cross Country Comparison, Revenue ($m), USD Constant, 2004-

2018

Source: GlobalData

Table 1: In Vitro Diagnostics, Cross Country Comparison, Revenue ($m),USD Constant, 2004-2018

Country Name 2004 2011 2018 CAGR 04-11 CAGR 11-18 CAGR 04-18

Source: GlobalData

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3.2 In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018

Figure 2: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018

Source: GlobalData

SAMPLE





Table 2: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018

Category 2004 2011 2018 CAGR 04-11 CAGR 11-18 CAGR 04-18

Source: GlobalData

SAMPLE

Appendix




10 Appendix

The data and analysis within this report is driven by Medical eTrack

Medical eTrack gives you the key information to drive sales, investment and deal making activity in

your business. It includes the following information:

15,000+ Market size data tables across 740 medical equipment segments and 39 countries with

historic data from 2004 forecast to 2018

6,000+ Primary expert interviews conducted per annum for ensuring data and report quality

1,100+ Conferences on medical equipment covered

1,000+ Industry leading reports per annum covering growing sectors, market trends, investment

opportunities and competitive landscape

600+ Analysis reports covering market and pipeline product analysis reports by indication, medical

equipment trends and issue reports and investment and M&A trend reports worth over $3 Million

43,000+ Medical equipment companies profiled

1,500+ Private, emerging and technology start-up company profiles

1,500+ Medical equipment manufacturers in China and India

1,500+ Medical equipment companies in Japan

700+ Companies with revenue splits and market shares by category

1,500+ Quarterly and annual medical equipment company financials

700+ Medical equipment company SWOT‘s

9,000+ Pipeline product profiles

8,000+ Marketed product profiles

14,000+ Clinical trials

15,000+ Trial investigators

13,000+ New product patents

3,300+ Companies with products in development

17,000+ Deals in the medical equipment industry

1,100+ Surgical and diagnostic procedures by therapy area

40+ Key healthcare indicators by country

o For more information or to receive a free demo of the service visit

http://www.medicaletrack.com/contactus.aspx?RD=Demo=

http://www.medicaletrack.com/contactus.aspx?RD=Demo

SAMPLE

Appendix




10.1 Definitions of Markets Covered in the Report

10.1.1 In Vitro Diagnostics

In Vitro Diagnostics (IVD) include reagents, instruments and systems intended for use in the

diagnosis of disease or other conditions, including the determination of the state of health, in order

to treat or prevent disease. Such reagents, instruments and systems are intended for use in the

collection, preparation and examination of specimens taken from the human body. The categories

tracked under this market are clinical chemistry, immunochemistry, haematology, histology &

cytology, infectious immunology, microbiology culture and genetic testing. In this market only

values have been tracked.

10.1.1.1 Clinical Chemistry

Clinical chemistry includes reagents, test kits and devices that determine the concentration or

activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecules in easily-collected

bodily fluids such as blood, serum, plasma or urine. Immuno chemical reagents are not included

under this category and are tracked separately under Immuno chemistry. This category comprises

of reagents for enzyme chemistry, metabolite chemistry and electrolyte chemistry. Rapid tests for

all enzymes, metabolites and electrolyte analysis and instruments used for clinical chemistry

diagnosis are also covered in this category.

Clinical Chemistry Rapid Tests & POC

Clinical chemistry rapid tests provide the test results immediately. These tests are used in low

resource settings with the help of test strips, tablets and solutions. Clinical chemistry PoC

diagnostics are used to determine the concentration or activity of blood gas, electrolytes,

metabolites, enzymes, carbohydrates, proteins, lipids and small molecules. These tests are

performed for the analysis of body fluids such as blood, serum, sputum, urine, feces and others.

Blood glucose testing is not tracked in this segment.

Clinical Chemisty Analyzers

Clinical chemistry analyzers are instruments used to perform tests relating to enzyme chemistry,

metabolite chemistry and electrolyte chemistry. Clinical chemistry analyzers can be fully

automated or semi automated.

Automated Clinical Chemistry Analyzers

A fully automated clinical chemistry analyzer is connected to a software program that allows the

user to feed in most test parameters. The tasks associated with performing the test like dispensing

the reagents and incubation are automated and require minimum manual work.

Semi-Automated Clinical Chemistry Analyzers

A semi-automated clinical chemistry analyzer requires an operator to perform the reagent

dispensing, incubation and other tasks manually.

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Electrolyte Chemistry Reagents

Reagents used to quantify or detect electrolytes to detect bodily functions and disease states.

Examples of electrolytes tracked include sodium, potassium, chloride, bicarbonate, magnesium,

calcium etc from the extra cellular fluids of the body.

Enzyme Chemistry Reagents

Reagents and test kits used for quantification and detection of enzymes that act as a marker for

identification and determination of disease states and bodily functions. Examples of enzymes

tracked include acid phosphatase, alkaline phosphatase, creatine kinase lactate dehydrogenase

etc.

Metabolite Chemistry Reagents

Reagents used for the quantification of metabolites for the assessment of bodily functions and

disease states. Examples of metabolites tracked are creatinine, cholesterol, triglycerides, albumin,

bilirubin etc.

Urine Analysis

Urine analysis is the analysis of urine to aid in the diagnosis of disease or to detect the presence of

a specific substance.

Urine Analyzer Reagents

Urine analyzer reagents are the reagents used in urine analyzers.

Urine Analyzers

Urine analyzers are analytical laboratory equipment used in qualitative and semi-quantitative tests

performed on a urine sample.

10.1.1.2 Genetic Testing

Genetic testing reagents are used for the identification of specific syndrome present in an

individual and can improve the accuracy of the diagnostic tests leading to a better treatment.

Reagents used to perform acquired gene or chromosome alterations, inborn gene or chromosome

alterations and other genetic tests have been tracked under this category.

Acquired Gene or Chromosome Alterations

Reagents which are used in genetic tests to detect cancer causing genes/related alterations like

p53, k-ras, BRCA 1+2 etc.

Inborn Gene or Chromosome Alterations

Genetic tests to detect monogenetic disorders (like Cystic Fibrosis, Haemochromatosis,

Prothrombin Mutation etc), polygenetic disorders (like Asthma, Atherosclerosis, Diabetes,

Hypertension, Osteoporosis, etc), chromosomal disorders (like Down's Syndrome, Edwards

Syndrome etc), polymorphisms (like HLA-Typing etc).

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Other Genetic Tests

Other genetic tests include pharmaco-genomics which include test related to cytochrome P450

(CYP 450). These tests can be by either individual tests or multiple tests which are conducted on

micro-arrays.

10.1.1.3 Haematology

Haematology includes reagents, rapid tests and instruments used for determination and diagnosis

of both physiological and pathological aspects of blood and its components. The category also

includes immune related reagents used for analysis of blood and its components.

Haematology Analyzers

Analytical laboratory equipments which are used to perform tests related to blood and its

components. These analyzers are also used to identify and determine morphology of blood and

blood-forming cells such as white blood cells, lymphocytes, monocytes, neutrophils, eosinophils

and basophils.

Haematology Cell Counters

These are blood counters used for complete blood count determination in routine examinations.

Differential Counters

These are instruments which are used in the measurement of the percentage of each type of white

blood cell of an individual. It also detects if there are any abnormal or immature cells in an

individual.

Hemoglobinometers

These are Instruments which are used for colorimetric representation of the percentage of

haemoglobin in a blood sample.

Haematology Rapid Tests

These are spot tests that generate results immediately and can be done in low resource setting.

These tests are performed to detect the Haemoglobin, Erythrocytes and Haematocrit etc

Erythrocytes (Ery)

Rapid test kits used for detecting the concentration of Erythrocytes in human blood are covered

under Erythrocytes (Ery) rapid test kits.

Haematocrit (HCT)

Rapid test kits used for detecting the concentration of Haematocrit (HCT) in human blood are

covered under Haematocrit (HCT) rapid test kits.

Haemoglobin (Hb)

Rapid test kits used for detecting the concentration of haemoglobin in human blood are covered

under Haemoglobin (Hb) rapid test kits.

Haemostasis Rapid Tests (Home Monitoring)

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Appendix




These are spot tests to detect haemostasis. These include prothrombin time rapid test, D-Dimer

rapid test, activated clotting time (ACT) rapid test etc

Haematology Reagents

These are reagents that are provided for substantially lysing the red blood cells in a whole blood

sample prior to haematology analysis.

Haematology Analyzer Reagents

Haematology analyzer reagents are exclusively used in blood lysing techniques. These reagents

generally contain tris-HCl, EDTA, EGTA, SDS, deoxycholate, tritonX, etc.

Slide Stainers

Slide stainers are reagents used in the staining of slides and smears. Reagents like crystal violet,

safranin, etc have been tracked.

Haemostasis

These include test kits and reagents that are used to conduct blood coagulation related tests.

Coagulation analyzers and reagents used to conduct various coagulation tests have been tracked

under this segment.

Coagulation Analyzers

These are automated or semi automated laboratory equipments used in clotting assay,

chromogenic assay, haemostasis profile etc.

Coagulation Factors

Reagents used in the detection of the coagulation factors are covered here. These coagulation

factors such as Factor VII, VIII, IX, XII etc, are involved in the blood coagulation process.

General Coagulation Tests

Coagulation tests include INR/prothrombin time, activated partial thromboplastin time (APTT or

PTT), bleeding time, plasma thrombin time etc. These tests are useful to diagnose disease

condition such as Haemophilia, Uremia, Thrombocytopenia and Vitamin K deficiency.

Platelet Factors

These reagents are used to conduct tests in the determination of cytokines belonging to the

chemokine family.

Special Coagulation Tests

These are reagents which are used to conduct special coagulation tests which provide quantitative

determination of anticoagulant activities of heparin and thrombin formation.

Immunohaematology

Immuno haematology studies antigen-antibody reactions and analogous phenomena as they

relate to the pathogenesis and clinical manifestations of blood disorders.

ABO Typing

SAMPLE

Appendix




These are the reagents used for detecting blood types into four categories: Type A, Type B, Type

AB and Type O.

Antibody Detection

Antibody detection is done for the differential diagnosis of many different pathological conditions.

These determinations of specific antibodies to bacterial and viral pathogens as well as to parasites

enable the correct therapeutic measures to be taken.

Rhesus Typing

These are the tests which are used to detect Rh factor (antigen) on the surface of the red blood

cells.

10.1.1.4 Histology And Cytology

These are reagent test kits and instruments used in tissue and cell typing techniques. Flow

cytometers, monoclonal antibodies and tissue typing reagents have been tracked under this

category.

Flow Cytometers

Flow cytometers are an electronic detection apparatus used in a technique for counting and

examining microscopic particles, such as cells and chromosomes, by suspending them in a stream

of fluid.

Monoclonal Antibodies

Monoclonal antibodies for cell surface antigen are antibodies from a single clone of hybridoma

cells. These are used for specific target cells which identify the tissue by the cell surface antigen.

Tissue Typing Reagents

These are the reagents which are used to determine the compatibility of tissues between a

prospective donor and a recipient prior to transplantation.

10.1.1.5 Immuno Chemistry

The immunochemistry category includes reagents, instruments and test kits used for the analysis

of antigen-antibody interactions in any of the bodily fluids. The category includes both test kits and

reagents for quantification and detection of specific proteins, hormones, drug moieties and non-

infectious diseases. Reagents and kits used in the diagnosis of infectious disease are not included

in this category.

Anemia / Vitamin Tests

Reagents used for estimation of anaemia and vitamin deficiency. These includes the reagents

used for quantitative measurement of iron, ferritin, folate and vitamin B 1, 2, 6, 12, Vitamin-D

Disease Specific Immunochemistry

Disease specific immunochemistry is an assay of specific markers of a particular disease. These

tests include assays of mostly antibodies released in response to a specific disease and also other

disease-causing proteins.

SAMPLE

Appendix




Allergy Blood Tests

Allergy Blood test is allergen-specific IgE antibody test used to measure the amount of

immunoglobulin (Ig) E antibodies to a specific allergen in the blood. A blood test tells a physician

what type of antibodies your blood contains in order to provide information on what is causing your

allergies. The test kits or reagents used to perform allergy blood test are covered under this sub

segment.

Auto-Immune Diseases

This includes the reagents and kits used to perform tests for the diagnosis of immune system

disorders and other disease states to detect auto-antibodies, which are antibodies produced

against the body‘s own tissues. The tests are used for the diagnosis of certain autoimmune

disease such as Addison‘s disease, autoimmune pancreatitis, Celiac disease, Crohns Disease,

Diabetes mellitus type 1, etc. The kits in this sub-segment include anti-nuclear antibody (ANA) kits,

etc.

Cardiac Markers

Cardiac marker tests function to identify blood chemicals associated with myocardial infarction and

other acute coronary syndromes. The tests include assays for proteins and chemicals like Creatine

Kinase-MB (CK-MB), myoglobin, homocysteine, C-Reactive Protein (CRP), troponin T (cTnT) and

troponin I (cTnI), associated with heart diseases.

Rheumatoid - Inflammatory Diseases Markers

These are the reagents used to detect Rheumatoid – Inflammatory diseases markers. These

markers are antigen/antibodies that detect specific antigen/antibodies produced by bone, cartilage

or any other inflammatory disease activity.

Tumor markers

The reagents used in the tests that detect specific antibodies/antigen produced by the tumor itself

or by the body in response to the tumor. Some commonly detected tumor markers include CA19-9,

CA15-3, CA-125, AFP, etc. The tests can assay markers from samples of blood, urine or body

tissue.

Drugs of Abuse / Toxicology

Test kits used to determine the type and approximate amount of legal and illegal drugs a person

has taken are covered under Drugs of abuse/ Toxicology. Screening is most often done using a

blood or urine sample. This segment includes drugs of abuse and toxicology.

Drugs of Abuse

Test kits for measurement of drugs of abuse from blood, serum or urine. These are the systems

used for testing of depressants, narcotics, stimulants and hallucinogens.

Toxicology

SAMPLE

Appendix




These are test kits for measurement of toxic substances or drugs from the blood or urine sample.

These are systems used for testing of drugs like Acetaminophene (Paracetamol), 5-

Aminolevulinate Dehydratase, Desipramine, Hippuric Acid, Phenols, Ethanol (Alcohol), etc.

Endocrinology Tests

Reagents used for quantification and detection of endocrine hormones secreted in the human

body. These include the thyroid function hormones, pregnancy hormones, individual and specified

hormones.

Fertility or Pregnancy Hormones

Pregnancy test system intended for the early detection of pregnancy by the measurement of

Human Chorionic Gonadotropin (HCG), a placental hormone, in plasma or urine.

Individual and Specified Hormones

Reagents used for a quantitative measurement of specific hormones for any purpose other than

pregnancy and thyroidal hormones are included here. They include reagents for testing of

hormones like Estrogen, Estradiol, Estriols, Adrenocorticotropic hormone, Aldosterone etc.

Thyroid Function Hormones

Reagents used for the quantification and detection of hormones secreted by the thyroid gland.

Reagents used to test TSH, T3 and T4 are included in this segment.

Immunochemistry Analyzers

Immunochemistry analyzers are analytical laboratory equipments used to perform tests for specific

proteins and therapeutic drugs. These analyzers are typically offered in modular increments, which

can operate independently or simultaneously as a unit. Analyzers covered under this category

include Chemiluminescence Analyzers, Radioimmunoassay Analyzers, Immunofluorescence

Analyzers and ELISA Instruments. Analyzers used to perform chemical analysis (enzyme,

electrolyte, metabolic or urine analysis are excluded and are covered under clinical chemistry.

Chemiluminescence Analyzers

Chemiluminescence analyzers are analytical laboratory equipments used to detect glow-based

chemiluminescent reactions. These are used for the quantitative determination of bio-molecules

such as hormones, antibodies to infectious diseases and other proteins in human serum and

Plasma.

ELISA Instruments

ELISA Instruments are used in enzyme-linked immuno sorbent assays for the diagnostic analyses

of antigens or antibodies in a solution using colorimetric signals. These instruments include micro

plate readers, ELISA washers, ELISA reader, etc.

Immunofluorescence Analyzers

SAMPLE

Appendix




Immunofluorescence analyzers are analytical laboratory equipments used for the visualization of

sub cellular distribution antibodies or antigens of interest. Using these analyzers the bio-molecules

of interest are labelled with specific antibodies chemically conjugated with fluorescent dye.

Radioimmunoassay Analyzers

Radioimmunoassay analyzers are analytical laboratory equipments used to measure

concentrations of antigens (for example, hormone levels in the blood) using radioactive

substances without the need to use a bioassay.

Immunochemistry Rapid Tests

Spot test kits intended generally for rapid diagnosis with immediate results, through immuno

assays. Some of the tests carried out using immunochemistry rapid test include rabies virus test,

allergenic food proteins and enteric infection

Drugs of Abuse / Toxicology Rapid Tests

Rapid immunodiagnostic tests intended for immediate detection and measurement of illegal and

legal drugs a person has taken. These tests detects and measures Amphetamines,

Amphetamine/Methamphetamine Specific (+Ecstasy), Barbiturates, Benzodiazepines,

Cannabinoids, Cocaine, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressants, etc in

blood, serum and urine samples.

Fertility / Pregnancy Rapid Tests

Rapid immunodiagnostic tests intended for immediate detection of fertility / pregnancy by

measurement of Follicle-stimulating hormone (FSH), Human placental lactogen (HPL), Human

luteinizing hormone (LH) and Human chorionic gonadotropin (HCG) hormone in plasma, serum

and urine samples.

Other Immunochemistry Rapid Tests

Immunodiagnostic tests intended for the immediate detection of Individual and Specified

Hormones/Proteins, Albumin, uAlbumin, Glycosylated/Glycated Haemoglobin, Prostate-specific

antigen (PSA), Bladder tumor antigen (BTA stat), C - Reactive protein, Rheumatoid / Inflammatory

Disease protein, Creatine Kinase, Myoglobin, Troponin, BNP / proBNP, Heart-Type Fatty Acid-

Binding Protein, etc. in plasma, serum and urine samples.

Organ Function Assays

These include test systems usually carried out through blood or urine test, for evaluating the

wellness of a specific organ through an assay of the organ metabolites. These include liver

function tests, kidney function tests etc.

Specific Proteins

These are reagents and test kits which are used to quantify and detect protein molecules from

bodily fluids. Immunoglobulins (without IgE), HAMA, Immunoelectrophoresis & ImmunoFixation

Kits, Complement Components, Transport Proteins, Lipoproteins, AGP, AAT, Micro and Macro G

etc. have been tracked under this segment.

SAMPLE

Appendix




Therapeutic Drug Monitoring

Therapeutic drug monitoring include reagents and test kits intended to measure different types of

therapeutic drugs from samples ranging from serum/blood, urine, hair and sweat. Test kits for

measurement of both proteins based and chemical based therapeutic drugs are covered. This

include tests for antibiotics, anti analgesics, anti-inflammatory, antipyretic and menstrual drugs.

Antibiotic TDM / Antivirus TDM

Therapeutic drug monitoring reagents used for the measurement of antibiotics or antivirus are

covered under antibiotic/antivirus TDM. Reagents used for detection of antibiotics like Gentamicin,

Sisomycin, Streptomycin, Netilmycin etc are covered here.

Cardiovascular TDM

Therapeutic drug monitoring reagents used for the measurement of drugs specific for

cardiovascular diseases at timed intervals in order to maintain a relatively constant concentration

of the medication in the bloodstream are covered under Cardiovascular TDM. Reagents used for

detection of cardiovascular drugs like Digoxin, Procainamide, Propranolol, Quinidine, etc are

covered here.

Central Nervous Systems TDM

Therapeutic drug monitoring reagents used for the measurement of drugs specific for central

nervous system are covered under central nervous systems TDM. Reagents used for detection of

central nervous systems drugs like Carbamazepine, Ethosuximide, Free Primodine, Valproic Acid

etc are covered here.

Immunosuppressant TDM

Therapeutic drug monitoring reagents used for the detection of immunosuppressant concentration

in human body are covered under immunosuppressant TDM. This includes reagents used for

detection of Immunosuppressant like Cyclosporin, Mycophenolate, Tacrolimus, etc.

10.1.1.6 Infectious Immunology

This category includes reagents and test kits used for the detection or quantification of infectious

agents like bacteria and viruses by using antigen-antibody (Ag – Ab) and nucleic acid tests.

Bacteriology

Reagents and test kits to detect the pathogenicity of bacteria such as chlamydia, gonococci,

syphilis, helicobacter pylori, salmonella and so on.

Hepatitis Viruses

These are diagnostic test kits which are used to detect the hepatitis virus such as HAV, HBV,

HCV, HbsAg and HXV.

SAMPLE

Appendix




Infectious Immunology Rapid Tests

Spot test kits intended generally for rapid diagnosis with immediate results, through immuno

assays. Tests carried out using Infectious Immunology rapid test include Hepatitis Virus,

Retrovirus and Other Virology Rapid Tests.

Hepatitis Viruses Rapid Tests

Immunodiagnostic tests intended for immediate detection of HBsAg, HCV Antibody and other

Hepatitis Viruses.

Other Infectious Immunology Rapid Tests

Immunodiagnostic tests intended for immediate detection of Chlamydia Ag, H. pylori, Strep. A,

Strep. B, Syphilis, Clost. diff. including Toxin A and B, Meningitis causitive agents, Legionella,

Strep. Pneumoniae, CMV, RSV, Mononucleosis (EBV), Influenza A and/or B, VZV, Dengue,

Plasmodium (Malaria), etc.

Retroviruses Rapid Tests

Immunodiagnostic rapid tests intended for immediate detection of HIV 1, HIV 1 / 2, HIV Ag/Ab

Combi and other Retroviruses.

Other Virology

These are diagnostic test kits which are used to confirm the antigen/antibody of rubella,

cytomegalovirus, the herpes simplex virus and the Epstein Barr Virus.

Retroviruses

These are diagnostic test kits which are used to detect the antigen/antibody of HIV1, HIV 2 and

HTLV I, HTLVII.

10.1.1.7 Microbiology Culture

This category includes reagents used for the preparation of growth medium for microbial

organisms. This category also includes dehydrated and prepared culture media for micro organism

growth.

Bacterial Identification & Susceptibility Testing

This includes the reagents and test kits (manual and automated) used to identify and test the

sensitivity of bacteria towards an antimicrobial substance.

Blood Culture

Culture media used for the preparation of medium capable of supporting the growth of bacteria

and other micro organisms. It is a culture of blood, used to identify the infection of blood stream

like bacteremia, septicaemia, etc. They are generally in solid/liquid forms or only solid and liquid

forms with constituents specific to the bacteria.

SAMPLE

Appendix




Immunological Culture Identification

Reagents used to test the streptococci grouping, meningitis, staphylococci and serotyping.

Microbiology Analyzers

These are analytical laboratory equipments used to perform routine and special microbiology tests.

These include fully automated or semi automated microbiology analyzers.

Automated Microbiology Analyzers

A fully automated analyzer is connected to a software program that allows the user to feed in most

test parameters. The tasks associated with performing the test like dispensing the reagents,

incubation etc are automated and require minimum manual work.

Semi-Automated Microbiology Analyzers

A semi-automated analyzer requires an operator to perform the reagent dispensing, incubation

and other tasks manually.

Mycobacteria Culture

It includes the culture media used for the preparation of medium capable of supporting the growth

of mycobacterium.

Mycology Culture

It includes culture media and reagents for the preparation of culture medium that is capable of

supporting the growth of fungi. These cultures are used to detect infection like dermatophyte

infections, etc

Parasitology Culture

Culture media used for the preparation of medium capable of supporting the growth of blood

parasites like plasmodium, pneumocystis etc.

Note: 1). Value, distribution and company shares figures reflect annual gross sales of in vitro

diagnostics in local currency converted to $ at constant rate. The annual growth (year on year

growth) and compounded annual growth rate (CAGR) in tables is rounded off to one decimal

place.

2). Company share data represents market share (in revenues and as percentage to total market)

of companies in market categories and geographies tracked. The data is rounded off to the

nearest decimal places.

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10.2 Research Methodology

GlobalData‘s dedicated Research and Analysis Teams consists of qualified professionals with

experience in marketing, market research, consulting background in the medical devices industry

and advanced statistical expertise.

GlobalData adheres to the Codes of Practice of the Market Research Society (www.mrs.org.uk) and

the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research

methodology is followed for all databases and reports.

10.3 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources

being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and SEC

filings;

Industry trade journals, scientific journals and other technical literature;

Internal and external proprietary databases;

Relevant patent and regulatory databases;

National government documents, statistical databases and market reports;

Procedure registries; and

News articles, press releases and web-casts specific to the companies operating in the market.

http://www.mrs.org.uk/

http://www.scip.org/

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10.4 Primary Research

GlobalData conducts thousands of interviews a year with industry participants and commentators

in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on market size, market trends, growth trends, competitive

landscape and future outlook;

Helps in validating and strengthening the secondary research findings; and

Further develops the analysis team‘s expertise and market understanding.

Primary research involves e-mail interactions and telephonic interviews for each market, category,

segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and

national sales managers;

Hospital stores, laboratories, pharmacies, distributors and paramedics;

Outside experts: investment bankers, valuation experts, research analysts specializing in specific

medical equipment markets; and

Key opinion leaders: physicians and surgeons specializing in different therapeutic areas

corresponding to different kinds of medical equipment.

10.5 Models

Where no hard data is available, GlobalData uses modeling and estimates in order to produce

comprehensive data sets. The following rigorous methodology is adopted:

Available hard data is cross-referenced with the following data types to produce estimates:

Demographic data on population segments;

Macro-economic indicators such as GDP, inflation rate;

Healthcare indicators such as health expenditure, physician base, healthcare infrastructure and

facilities; and

Selected epidemiological and procedure statistics.

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10.6 Forecasts

GlobalData uses proprietary forecast models. The following four factors are utilized in the forecast

models:

Historic growth rates;

Macro-indicators such as population trends and healthcare spending;

Forecast epidemiological data; and

Qualitative trend information and assumptions.

The data is then cross-checked by the expert panel.

10.7 Expert Panels

GlobalData uses a panel of experts to cross verify its databases and forecasts.

GlobalData‘s expert panel comprises marketing managers, product specialists, international sales

managers from medical device companies; academics from research universities, KOLs from

hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment

and supplies etc.

Historic data and forecasts are relayed to GlobalData‘s Expert Panel for feedback and adjusted in

accordance with their feedback.

10.8 GlobalData Consulting

We hope that the data and analysis in this brief will help you make informed and imaginative

business decisions. If you have further requirements, GlobalData‘s consulting team may be able to

help you. GlobalData offers tailor-made analytical and advisory services to drive your key strategic

decisions.

10.9 Currency Conversion

The Currency Conversion rate is based on 2011 average rate. 1 USD =

Canada 0.989 CAD.

10.10 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior

permission of the publisher, GlobalData.

North America In Vitro Diagnostics Market Outlook to 2018 ... · 7.7 Genetic Testing Market Pipeline Products 149. 8 Financial Deals Landscape 154. 8.1 Acquisition 154. 8.1.1 SQI

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