REFERENCE CODE GDME1013FPR | PUBLICATION DATE AUGUST 2013 IN-VITRO COLORECTAL CANCER SCREENING TESTS - CURRENT AND FUTURE PLAYERS
REFERENCE CODE GDME1013FPR | PUBLICATION DATE AUGUST 2013
IN-VITRO COLORECTAL CANCER SCREENING TESTS -
CURRENT AND FUTURE PLAYERS
In-Vitro Colorectal Cancer Screening Tests – Current and Future Players 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
IN-VITRO COLORECTAL CANCER SCREENING TESTS – CURRENT AND FUTURE PLAYERS
Table of Contents
1 Table of Contents
1 Table of Contents ...................................................................................................................... 2
1.1 List of Tables ........................................................................................................................ 6
1.2 List of Figures ..................................................................................................................... 12
2 Introduction ............................................................................................................................. 13
2.1 Catalyst ............................................................................................................................... 13
2.2 Related Reports .................................................................................................................. 13
3 Competitive Assessment ......................................................................................................... 14
3.1 Overview ............................................................................................................................. 14
3.2 Fecal Occult Blood Tests .................................................................................................... 14
3.2.1 Guaiac Fecal Occult Blood Stool Tests ........................................................................... 14
3.2.2 Lateral Flow Immuno-Fecal Occult Blood Tests .............................................................. 18
3.2.3 Readers .......................................................................................................................... 25
3.2.4 Immuno-FOB Test ELISA ............................................................................................... 28
3.2.5 Immuno-FOB Agglutination Tests ................................................................................... 31
3.3 CRC DNA Screening Tests ................................................................................................. 41
3.3.1 Panel DNA Tests ............................................................................................................ 41
3.3.2 Methylated Gene Testing ................................................................................................ 51
3.4 Other Biomarker Tests ........................................................................................................ 60
3.4.1 Overview ........................................................................................................................ 60
3.4.2 Tumor M2-PK Stool Test/2-in-1 Quick Test..................................................................... 60
3.4.3 Transferrin Assays .......................................................................................................... 62
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IN-VITRO COLORECTAL CANCER SCREENING TESTS – CURRENT AND FUTURE PLAYERS
Table of Contents
4 Pipeline Products .................................................................................................................... 64
4.1 Overview ............................................................................................................................. 64
4.2 Pipeline by Phases in Development .................................................................................... 64
4.3 Pipeline Product Profiles ..................................................................................................... 66
4.3.1 BST1 CRC Assay ........................................................................................................... 66
4.3.2 Cologic ........................................................................................................................... 67
4.3.3 ColoGuard ...................................................................................................................... 69
4.3.4 Colon Cancer BEC Test.................................................................................................. 73
4.3.5 Colon MarCare Plex ....................................................................................................... 74
4.3.6 Colox .............................................................................................................................. 77
4.3.7 CRC Bacterial Signature Assay ...................................................................................... 79
4.3.8 CRC Breath Test ............................................................................................................ 80
4.3.9 Epi proColon ................................................................................................................... 83
4.3.10 ExiQon MicroRNA Test ................................................................................................... 89
4.3.11 Gemini CRC Biomarker Assay ........................................................................................ 92
4.3.12 GenomicTree Methylated DNA Test ............................................................................... 93
4.3.13 Measure Fecal Occult Blood Test ................................................................................... 95
4.3.14 Metabiomics CRC Test ................................................................................................... 98
4.3.15 MiR-21 Test .................................................................................................................. 100
4.3.16 Oncolite CR .................................................................................................................. 102
4.3.17 PanC-Dx ....................................................................................................................... 104
5 Current and Future Players ................................................................................................... 107
5.1 Overview ........................................................................................................................... 107
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Table of Contents
5.2 Trends in Corporate Strategy ............................................................................................ 108
5.3 Company Profiles .............................................................................................................. 108
5.3.1 Abbott Molecular ........................................................................................................... 108
5.3.2 Alere ............................................................................................................................. 110
5.3.3 Beckman Coulter .......................................................................................................... 113
5.3.4 Biomarcare Technologies ............................................................................................. 114
5.3.5 Companion Dx .............................................................................................................. 116
5.3.6 Eiken Chemical ............................................................................................................. 117
5.3.7 Epigenomics ................................................................................................................. 120
5.3.8 Exact Sciences ............................................................................................................. 125
5.3.9 ExiQon .......................................................................................................................... 129
5.3.10 Fujirebio (Miraca Holdings) ........................................................................................... 131
5.3.11 GeneNews .................................................................................................................... 134
5.3.12 GenomicTree ................................................................................................................ 135
5.3.13 Immunostics ................................................................................................................. 137
5.3.14 Kyowa Medex ............................................................................................................... 140
5.3.15 MDx Health (was OncoMethylome) .............................................................................. 142
5.3.16 Merck Millipore ............................................................................................................. 144
5.3.17 Metabiomics ................................................................................................................. 146
5.3.18 Mode Diagnostics ......................................................................................................... 148
5.3.19 Oncocyte (Bio Time) ..................................................................................................... 150
5.3.20 Quest Diagnostics......................................................................................................... 152
5.3.21 R-Biopharm .................................................................................................................. 156
In-Vitro Colorectal Cancer Screening Tests – Current and Future Players 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
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Table of Contents
5.3.22 Randox Laboratories .................................................................................................... 159
5.3.23 ScheBo Biotech ............................................................................................................ 160
5.3.24 SciMarket Technologies................................................................................................ 163
5.3.25 Siemens Healthcare ..................................................................................................... 164
5.3.26 Signature Diagnostics ................................................................................................... 167
5.3.27 Sysmex ......................................................................................................................... 168
5.3.28 Veda Lab ...................................................................................................................... 170
6 Appendix ............................................................................................................................... 173
6.1 Abbreviations .................................................................................................................... 173
6.2 Bibliography ...................................................................................................................... 176
6.3 Research Methodology ..................................................................................................... 207
6.3.1 Coverage ...................................................................................................................... 207
6.3.2 Secondary Research .................................................................................................... 208
6.4 Physicians and Specialists Included in this Study ............................................................. 209
6.5 Primary Research ............................................................................................................. 210
6.6 About the Authors ............................................................................................................. 211
6.6.1 Analysts ........................................................................................................................ 211
6.6.2 Global Head of Healthcare ............................................................................................ 212
6.7 About GlobalData .............................................................................................................. 213
6.8 Disclaimer ......................................................................................................................... 213
In-Vitro Colorectal Cancer Screening Tests – Current and Future Players 6 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
IN-VITRO COLORECTAL CANCER SCREENING TESTS – CURRENT AND FUTURE PLAYERS
Table of Contents
1.1 List of Tables
Table 1: CRC Screening Test Segmentation ............................................................................................. 14
Table 2: Guaiac Fecal Occult Blood Tests Product Profile ......................................................................... 15
Table 3: Guaiac FOB Test SWOT Analysis, 2013 ..................................................................................... 17
Table 4: Immuno-FOB Tests ..................................................................................................................... 22
Table 5: Product Profile – Lateral Flow Immunochemical Fecal Occult Blood Tests ................................... 24
Table 6: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, 2013 .......................... 25
Table 7: Product Profile – Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood
Tests with Readers) .................................................................................................................... 26
Table 8: Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers)
SWOT Analysis, 2013 ................................................................................................................. 27
Table 9: Fecal Occult Blood ELISA Products ............................................................................................ 28
Table 10: Product Profile – Fecal Occult Blood ELISA ................................................................................ 29
Table 11: Immuno-FOB Test ELISA SWOT Analysis, 2013 ......................................................................... 30
Table 12: Commercially Available Immuno-FOB Agglutination Test Systems .............................................. 38
Table 13: Product Profile – Immuno-FOB Agglutination Tests ..................................................................... 38
Table 14: Immuno-FOB Agglutination Tests SWOT Analysis, 2013 ............................................................. 40
Table 15: Key Mutations Associated with CRC ........................................................................................... 42
Table 16: Key Stages of PCR Gene Test .................................................................................................... 43
Table 17: Product Profile – PreGen Plus ..................................................................................................... 45
Table 18: PreGen Plus SWOT Analysis, 2013 ............................................................................................ 46
Table 19: Product Profile – K-RAS, B-RAF, PIK3CA Array .......................................................................... 47
Table 20: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, 2013 .................................................................. 48
Table 21: Product Profile – Colonsentry ...................................................................................................... 49
Table 22: Colonsentry SWOT Analysis, 2013 .............................................................................................. 49
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IN-VITRO COLORECTAL CANCER SCREENING TESTS – CURRENT AND FUTURE PLAYERS
Table of Contents
Table 23: Product Profile – Detector C 2.0 .................................................................................................. 50
Table 24: Detector C SWOT Analysis, 2013................................................................................................ 51
Table 25: Product Profile – ColoSure .......................................................................................................... 54
Table 26: ColoSure SWOT Analysis, 2013 .................................................................................................. 54
Table 27: Product Profile – MS9 ................................................................................................................. 56
Table 28: MS9 SWOT Analysis, 2013 ......................................................................................................... 57
Table 29: Septin-9 CRC Screening Marketed Laboratory-Developed Tests ................................................. 57
Table 30: Product Profile – ColoVantage/Septin-9 ...................................................................................... 58
Table 31: ColoVantage/Septin-9 SWOT Analysis, 2013 .............................................................................. 59
Table 32: Product Profile – Tumor M2-PK Stool Test/2-in-1 Quick Test ....................................................... 61
Table 33: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis, 2013 .............................................. 62
Table 34: Product Profile – Transferrin Assays ........................................................................................... 63
Table 35: Transferrin Assays SWOT Analysis, 2013 ................................................................................... 63
Table 36: CRC Screening Tests Pipeline, 2012........................................................................................... 65
Table 37: Product Profile – BST1 CRC Assay ............................................................................................. 66
Table 38: BST1 CRC Assay SWOT Analysis, 2013..................................................................................... 67
Table 39: Product Profile – Cologic ............................................................................................................. 68
Table 40: Cologic SWOT Analysis, 2013..................................................................................................... 69
Table 41: Product Profile – ColoGuard ........................................................................................................ 71
Table 42: ColoGuard SWOT Analysis, 2013 ............................................................................................... 73
Table 43: Product Profile – Colon Cancer BEC Test ................................................................................... 74
Table 44: Colon Cancer BEC Test SWOT Analysis, 2013 ........................................................................... 74
Table 45: Product Profile – Colon MarCare Plex ......................................................................................... 75
Table 46: Colon MarCare Plex SWOT Analysis, 2013 ................................................................................. 76
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Table 47: Product Profile – Colox................................................................................................................ 78
Table 48: Colox SWOT Analysis, 2013 ....................................................................................................... 79
Table 49: Product Profile – CRC Bacterial Signature Assay ........................................................................ 80
Table 50: CRC Bacterial Signature Assay SWOT Analysis, 2013 ................................................................ 80
Table 51: Product Profile – CRC Breath Test .............................................................................................. 82
Table 52: CRC Breath Test SWOT Analysis, 2013 ...................................................................................... 82
Table 53: Product Profile – Epi proColon .................................................................................................... 85
Table 54: Epi proColon Clinical Trials ......................................................................................................... 85
Table 55: Epi proColon SWOT Analysis, 2013 ............................................................................................ 89
Table 56: ExiQon MicroRNA Sensitivity and Specificity ............................................................................... 90
Table 57: Product Profile – ExiQon microRNA Test..................................................................................... 90
Table 58: ExiQon microRNA Test SWOT Analysis, 2013 ............................................................................ 91
Table 59: Product Profile – Gemini CRC Biomarker Assay .......................................................................... 92
Table 60: Gemini CRC Biomarker Assay SWOT Analysis, 2013 ................................................................. 93
Table 61: Product Profile – GenomicTree Methylated DNA Test ................................................................. 94
Table 62: GenomicTree Methylated DNA Test SWOT Analysis, 2013 ......................................................... 95
Table 63: Product Profile – Measure ........................................................................................................... 97
Table 64: Measure SWOT Analysis, 2013 ................................................................................................... 97
Table 65: Product Profile – Metabiomics CRC Test ..................................................................................... 99
Table 66: Metabiomics CRC Test SWOT Analysis, 2013 .......................................................................... 100
Table 67: Product Profile – miR-21 Test.................................................................................................... 101
Table 68: miR-21 Test SWOT Analysis, 2013 ........................................................................................... 101
Table 69: Product Profile – Oncolite-CR.................................................................................................... 102
Table 70: Oncolite-CR SWOT Analysis, 2013 ........................................................................................... 103
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IN-VITRO COLORECTAL CANCER SCREENING TESTS – CURRENT AND FUTURE PLAYERS
Table of Contents
Table 71: Product Profile – PanC-Dx ........................................................................................................ 106
Table 72: PanC-Dx SWOT Analysis, 2013 ................................................................................................ 106
Table 73: Company Profile – Abbott Molecular ......................................................................................... 109
Table 74: Abbott Molecular SWOT Analysis, 2013 .................................................................................... 110
Table 75: Company Profile – Alere ........................................................................................................... 111
Table 76: Alere SWOT Analysis, 2013 ...................................................................................................... 112
Table 77: Company Profile – Beckman Coulter ......................................................................................... 113
Table 78: Beckman Coulter SWOT Analysis, 2013 ................................................................................... 114
Table 79: Company Profile – Biomarcare Technologies ............................................................................ 115
Table 80: Biomarcare Technologies SWOT Analysis, 2013 ....................................................................... 115
Table 81: Company Profile – Companion Dx............................................................................................. 116
Table 82: Companion Dx SWOT Analysis, 2013 ....................................................................................... 117
Table 83: Company Profile – Eiken Chemical ........................................................................................... 119
Table 84: Eiken Chemical SWOT Analysis, 2013 ...................................................................................... 120
Table 85: Company Profile – Epigenomics ................................................................................................ 123
Table 86: Epigenomics SWOT Analysis, 2013 .......................................................................................... 124
Table 87: Company Profile – Exact Sciences ............................................................................................ 125
Table 88: Exact Sciences SWOT Analysis, 2013 ...................................................................................... 129
Table 89: Company Profile – ExiQon ........................................................................................................ 130
Table 90: ExiQon SWOT Analysis, 2013 ................................................................................................... 131
Table 91: Company Profile – Fujirebio (Miraca Holdings) .......................................................................... 132
Table 92: Fujirebio SWOT Analysis, 2013 ................................................................................................. 133
Table 93: Company Profile – GeneNews .................................................................................................. 134
Table 94: GeneNews SWOT Analysis, 2013 ............................................................................................. 135
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Table 95: Company Profile – GenomicTree .............................................................................................. 136
Table 96: GenomicTree SWOT Analysis, 2013 ......................................................................................... 136
Table 97: Company Profile – Immunostics ................................................................................................ 137
Table 98: Immunostics SWOT Analysis, 2013 ........................................................................................... 139
Table 99: Company Profile – Kyowa Medex (Kyowa Hakko Kirin Group) ................................................... 140
Table 100: Kyowa Medex SWOT Analysis, 2013 ........................................................................................ 141
Table 101: Company Profile – MDx Health ................................................................................................. 142
Table 102: MDx Health SWOT Analysis, 2013 ............................................................................................ 144
Table 103: Company Profile – Merck Millipore ............................................................................................ 145
Table 104: Merck Millipore SWOT Analysis, 2013 ....................................................................................... 146
Table 105: Company Profile – Metabiomics ................................................................................................ 147
Table 106: Metabiomics SWOT Analysis, 2013 ........................................................................................... 148
Table 107: Company Profile – Mode Diagnostics ........................................................................................ 149
Table 108: Mode Diagnostics SWOT Analysis, 2013................................................................................... 150
Table 109: Company Profile – Oncocyte (Bio Time) .................................................................................... 150
Table 110: Oncocyte (Bio Time) SWOT Analysis, 2013 .............................................................................. 152
Table 111: Company Profile – Quest Diagnostics ....................................................................................... 153
Table 112: Quest Diagnostics SWOT Analysis, 2013 .................................................................................. 155
Table 113: Company Profile – R-Biopharm ................................................................................................. 157
Table 114: R-Biopharm SWOT Analysis, 2013 ............................................................................................ 158
Table 115: Company Profile – Randox Laboratories ................................................................................... 159
Table 116: Randox Laboratories SWOT Analysis, 2013 .............................................................................. 160
Table 117: Company Profile – ScheBo Biotech ........................................................................................... 161
Table 118: Schebo Biotech SWOT Analysis, 2013 ...................................................................................... 162
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Table 119: Company Profile – SciMarket Technologies .............................................................................. 163
Table 120: SciMarket Technologies SWOT Analysis, 2013 ......................................................................... 164
Table 121: Company Profile – Siemens Healthcare .................................................................................... 165
Table 122: Siemens Healthcare SWOT Analysis, 2013 ............................................................................... 166
Table 123: Company Profile – Signature Diagnostics .................................................................................. 167
Table 124: Signature Diagnostics SWOT Analysis, 2013 ............................................................................ 168
Table 125: Company Profile – Sysmex ....................................................................................................... 168
Table 126: Sysmex SWOT Analysis, 2013 .................................................................................................. 170
Table 127: Company Profile – Veda Lab ..................................................................................................... 171
Table 128: Veda Lab SWOT Analysis, 2013 ............................................................................................... 172
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1.2 List of Figures
Figure 1: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen ................................ 15
Figure 2: Fecal Occult Blood Test Lateral Flow Device Architecture ........................................................... 19
Figure 3: Biohit Colonview (example of immuno-FOB test) ......................................................................... 20
Figure 4: Beckman Coulter Hemoccult-ICT (example of immuno-FOB test) ................................................ 21
Figure 5: Veda Labs Easy Reader Immuno-FOB Test LFD Reader ............................................................ 26
Figure 6: OC-Hemodia Agglutination FOB Test (manually performed) ........................................................ 31
Figure 7: OC-Sensor/Diana FOB Test Sample Cartridge ............................................................................ 32
Figure 8: OC-Sensor/Diana FOB Test Instrument ...................................................................................... 33
Figure 9: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction .............................................. 34
Figure 10: Sentinel Diagnostic Sentifob Instrument ...................................................................................... 35
Figure 11: Alere CI5 NS-Plus Instrument...................................................................................................... 36
Figure 12: Orion Diagnostics Quikread FOB Test and Instrument ................................................................. 37
Figure 13: Basic PCR Process ..................................................................................................................... 44
Figure 14: MS9 PCR Response Curve ......................................................................................................... 56
Figure 15: Proposed ColoGuard Patient Stool Sample Collection Kit ............................................................ 70
Figure 16: Exact Sciences Automated Sample Processing WorkStation ....................................................... 71
Figure 17: Colox Kit Contents ...................................................................................................................... 77
Figure 18: Measure Fecal Occult Blood Test ................................................................................................ 96
Figure 19: PanC-Dx Multiplex Detection of CRC-specific Biomarker ........................................................... 105
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IN-VITRO COLORECTAL CANCER SCREENING TESTS – CURRENT AND FUTURE PLAYERS
Introduction
2 Introduction
Colorectal cancer (CRC) is the third most commonly diagnosed cancer, and the second most
common cause of mortality amongst cancer patients. Prognosis is directly related to early
diagnosis, with survival rates dramatically improved by early diagnosis and treatment. Thanks to
the introduction of CRC screening programs, mortality in the developed countries is falling;
however, incidence continues to rise as a result of diet and increasingly sedentary lifestyles. While
historically, colorectal cancer incidence in the developing world is low, in recent years, disease
diagnosis rates have dramatically increased, as a result of changing lifestyles, awareness and
improved access to medical services. CRC screening can improve survival rates, and reduce the
overall cost of patient treatment. This report focuses on the in-vitro CRC screening test markets in
the US and Europe (France, Germany, Italy, Spain, and the UK), Japan and future markets in
China, India and Brazil, and identifies unmet needs in the market, physician attitudes towards
current modalities in in-vitro CRC screening, and the future of CRC screening in the face of rapid
technological advancement.
2.1 Catalyst
Colorectal cancer screening can be carried out using a number of different methods which are
either invasive or non-invasive. Typical approaches include endoscopic examination of the bowel
or analysis of fecal samples for evidence of disease. Endoscopic procedures pose challenges, in
terms of patient access, cost and risk. Fecal sample analysis poses challenges in patient
compliance, disease sensitivity and disease specificity. New in-vitro tests promise improved
sensitivity and specificity, while at the same time improving patient compliance. Two new CRC
screening tests from Exact Sciences and Epigenomics are expected to receive FDA Premarket
Approval in late 2013 or early 2014, and these tests may dramatically change the in-vitro CRC
screening test landscape.
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IN-VITRO COLORECTAL CANCER SCREENING TESTS – CURRENT AND FUTURE PLAYERS
Appendix
6.7 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in medical device research, disease analysis, and clinical research and development. Our
integrated business intelligence solutions include a range of interactive online databases, analytical
tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, Boston, London, India and Singapore.
6.8 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.