FDA-CLEARED/APPROVED MOLECULAR DIAGNOSTICS TESTS This table is current through Nov 10, 2010 The following table is a listing of the in vitro molecular diagnostic products that are cleared or approved for diagnostic use in the United States by the Food and Drug Administration. Such tests are classified as "Medical Devices." More information is available at the website for FDA’s Office of In Vitro Diagnostic (OIVD) Evaluation and Safety: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm. This list is for informational purposes only and is not intended as an endorsement or recommendation in any way of the products and manufacturers listed by the Association for Molecular Pathology or any of its officers or members. Companies are listed alphabetically within each category. Every effort is made to keep this list error-free and current. Please email comments, corrections, additions, etc. to Carol A. Holland, Ph.D. ([email protected]). ABBREVIATIONS: 510(k): Premarket Notification PCR: Polymerase Chain Reaction ASPE: Allele Specific Primer Extension PMA: Premarket Approval bDNA: Branched Chain DNA Signal Amplification PNA: Peptide Nucleic Acid BLA: Biological License Application QC: Quality control DKA: Dual Kinetic Assay RT-PCR: Reverse-Transcription PCR ELISA: Enzyme-linked Immunosorbent Assay SDA: Strand Displacement Amplification FISH: Fluorescent in situ Hybridization TC: Target Capture HPA: Hybridization Protection Assay TMA: Transcription Mediated Amplification NASBA: Nucleic Acid Sequence Based Amplification
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FDA-CLEARED/APPROVED MOLECULAR DIAGNOSTICS TESTS
This table is current through Nov 10, 2010
The following table is a listing of the in vitro molecular diagnostic products that are cleared or approved for diagnostic use in the United States by the Food and Drug Administration. Such tests are classified as "Medical Devices." More information is available at the website for FDA’s Office of In Vitro Diagnostic (OIVD) Evaluation and Safety: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm. This list is for informational purposes only and is not intended as an endorsement or recommendation in any way of the products and manufacturers listed by the Association for Molecular Pathology or any of its officers or members. Companies are listed alphabetically within each category. Every effort is made to keep this list error-free and current. Please email comments, corrections, additions, etc. to Carol A. Holland, Ph.D. ([email protected]).
ABBREVIATIONS: 510(k): Premarket Notification PCR: Polymerase Chain Reaction ASPE: Allele Specific Primer Extension PMA: Premarket Approval bDNA: Branched Chain DNA Signal Amplification PNA: Peptide Nucleic Acid BLA: Biological License Application QC: Quality control DKA: Dual Kinetic Assay RT-PCR: Reverse-Transcription PCR ELISA: Enzyme-linked Immunosorbent Assay SDA: Strand Displacement Amplification FISH: Fluorescent in situ Hybridization TC: Target Capture HPA: Hybridization Protection Assay TMA: Transcription Mediated Amplification NASBA: Nucleic Acid Sequence Based Amplification
INFECTIOUS DISEASE TESTS - BACTERIAL and FUNGAL
TEST
MANUFACTURER
TEST NAME
METHOD REGULATORY
ROUTE FOR PREMARKET
REVIEW Bacillus anthracis Idaho Technology, Inc.
Salt Lake City, UT Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection kit
Real-time PCR 510(k)
AdvanDx Woburn, MA
C. albicans PNA FISH PNA FISH 510(k) Candida albicans and Candida spp.
AdvanDx Woburn, MA
Yeast Traffic Light PNA FISH™1 PNA FISH 510(k)
BD Diagnostics - GeneOhm San Diego, CA
GeneOhm Cdiff Assay Real-time PCR 510(k)
Cepheid Sunnyvale, CA
Xpert™ C. difficile Test (also see under Systems below: GeneXpert™ Real-time PCR System )
Real-time PCR 510(k)
Meridian Bioscience Cincinnati, OH
Illumigene™ C. difficile Loop amplification technology
510(k)
Clostridium difficile
Gen-Probe, Inc. (Prodesse) San Diego, CA
ProGastro™ Cd Assay Multiplex Real-time PCR
510(k)
BD Diagnostic Systems Sparks, MD
BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay
COBAS AMPLICOR® CT/NG Test for Neisseria gonorrhoeae1
PCR 510(k)
Abbott Molecular, Inc. Des Plaines, IL
Abbott® Real-time CT/NG (also see under Systems below: Abbott m2000™ [m2000sp + m2000rt])
Real-time PCR 510(k)
BD Diagnostics - GeneOhm San Diego, CA
BD ProbeTec™ ET C. trachomatis and N. gonorrhoeae amplified DNA Assay (also see under Systems below: BD Viper™ System)
SDA 510(k)
Gen-Probe, Inc. San Diego, CA
APTIMA Combo 2® Assay (also see under Systems below: TIGRIS® DTS™ System)
TC, TMA, DKA
510(k)
Gen-Probe, Inc. San Diego, CA
PACE® 2C CT/GC HPA 510(k)
Chlamydia trachomatis and Neisseria gonorrhoeae detection
Qiagen, Inc. Germantown, MD
HC2® CT/GC Combo Test Hybrid Capture 510(k)
Roche Molecular Diagnostics Pleasanton, CA
AMPLICOR® CT/NG Test PCR 510(k)
Roche Molecular Diagnostics Pleasanton, CA
COBAS AMPLICOR™ CT/NG Test1
PCR 510(k)
Enterococcus faecalis AdvanDx Woburn, MA
Enterococcus faecalis PNA FISH® PNA FISH 510(k)
Escherichia coli and Pseudomonas aeruginosa
AdvanDx Woburn, MA
E. coli/P. aeruginosa PNA FISH® PNA FISH 510(k)
Escherichia. coli, Klebsiella pneumoniae and Pseudomonas aeruginosa
AdvanDx Woburn, MA
EK/P. aeruginosa PNA FISH® PNA FISH 510(k)
Francisella tularensis Idaho Technology, Inc. Salt Lake City, UT
Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection kit
Real-time PCR 510(k)
Gardnerella, Trichomonas vaginalis and Candida spp. Detection
BD Diagnostics - GeneOhm San Diego, CA
BD Affirm™ VPIII Microbial Identification Test
Hybridization 510(k)
Group A Streptococci detection
Gen-Probe, Inc. San Diego, CA
Group A Strep direct (GASD) HPA 510(k)
AdvanDx Woburn, MA
GBS PNA FISH® PNA FISH 510(k)
BD Diagnostics - GeneOhm San Diego, CA
IDI-Strep B™ Assay Real-time PCR 510(k)
BD Diagnostics - GeneOhm San Diego, CA
BD Max™ GBS Assay Real-time PCR 510(k)
Cepheid Sunnyvale, CA
Smart GBS (also see under Systems below: SmartCycler™ Real-time PCR System )
Real-time PCR 510(k)
Cepheid Sunnyvale, CA
Xpert™ GBS (also see under Systems below: GeneXpert™ Real-time PCR System )
Real-time PCR 510(k)
Group B Streptococci detection
Gen-Probe, Inc. San Diego, CA
Group B AccuProbe® HPA 510(k)
BD Diagnostics - GeneOhm San Diego, CA
IDI-MRSA™ Assay Real-time PCR 510(k)
Cepheid Sunnyvale, CA
Xpert™ MRSA (also see under Systems below: GeneXpert™ Real-time PCR System )
Real-time PCR 510(k)
MRSA for Staphylococcus aureus - Screening assay
Roche Molecular Diagnostics Pleasanton, CA
LightCycler® MRSA Advanced Test (also see under Systems below: LightCycler® 2.0)
Real-time PCR 510(k)
MRSA/SA for Staphylococcus aureus - Screening assay
Cepheid Sunnyvale, CA
Xpert™ MRSA/SA Nasal Assay (also see under Systems below: GeneXpert™ Real-time PCR System )
Real-time PCR 510(k)
BD Diagnostics - GeneOhm San Diego, CA
GeneOhm StaphSR Real-time PCR 510(k) MRSA for Staphylococcus aureus -Diagnostic assay for positive blood cultures Cepheid
Sunnyvale, CA Xpert™ MRSA/SA Blood Culture Assay (also see under Systems below: GeneXpert™ Real-time PCR System )
Real-time PCR 510(k)
MRSA for Staphylococcus aureus -Diagnostic assay for Skin and Soft Tissue Infection
Cepheid Sunnyvale, CA
Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test (also see under Systems below: GeneXpert™ Real-time PCR System )
Real-time PCR 510(k)
Mycobacterium tuberculosis detection
Gen-Probe, Inc. San Diego, CA
AMPLIFIED™ Mycobacterium tuberculosis Direct Test (MTD)
TMA PMA
Mycobacteria spp., different fungi and bacteria culture confirmation
Gen-Probe, Inc. San Diego, CA
AccuProbe® Culture Identification Tests3
HPA 510(k)
Staphylococcus aureus AdvanDx Woburn, MA
S. aureus PNA FISH PNA FISH 510(k)
Vancomycin resistance Cepheid Sunnyvale, CA
Xpert vanA test (also see under Systems below: GeneXpert™ Real-time PCR System )
Real-time PCR 510(k)
1Five Candida species directly from positive blood cultures including: C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei
2C. trachomatis and N. gonorrhoeae detection may now be done using the Roche COBAS Amplicor system directly from Cytyc Corporation’s ThinPrep Pap test collection kit; this use is FDA Approved.
COBAS® TaqScreen MPX® Multiplex Real-time PCR and RT-PCR
BLA
Herpes Simplex virus 1 and 2 Eragen Biosciences Madison, WI
Multicode - RTX Herpes Simplex Virus 1 and 2 kit, Model 3711
Multicode chemistry PCR and Real-time PCR
510(k)
Human Metapneumovirus Gen-Probe, Inc. (Prodesse) San Diego, CA
Pro hMPV+™ Assay Multiplex Real-time RT-PCR
510(k)
Hologic, Inc. (Third Wave Technologies) Bedford, MA
Cervista™ HPV HR (high risk) Invader® Chemistry
PMA
Hologic, Inc. (Third Wave Technologies) Bedford, MA
Cervista™ HPV 16/18 Invader® Chemistry
PMA
Qiagen, Inc. Germantown, MD
HC2® HR and LR Hybrid Capture PMA
Qiagen, Inc. Germantown, MD
HC2®HPV HR Hybrid Capture PMA
Human Papillomavirus Testing
Qiagen, Inc. Germantown, MD
HC2® DNA with Pap Hybrid Capture PMA
Influenza Virus Panel
Centers for Disease Control Atlanta, GA
Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (also see under Systems below: ABI 7500 Fast Dx Real-Time PCR Instrument)
Real-time RT-PCR
510(k)
Influenza Virus – H1N1 Focus Diagnostics Cypress, CA
Simplexa™ Influenza test Real-time RT-PCR
510(k)
Luminex Molecular Diagnostics Toronto, Canada
xTAG Respiratory Viral Panel1
(also see under Systems below: Luminex LX 100/200)
RT-PCR, ASPE, Tag sorting
de novo 510(k)
Nanosphere, Inc. Northbrook, IL
Verigene® Respiratory Virus Nucleic Acid Test and Verigene®
Respiratory Virus Test-SP (also see under Systems below: Verigene® System)
Multiplex Gold Nanoparticle Probes
510(k)
Gen-Probe, Inc. (Prodesse) San Diego, CA
ProFlu+™ Assay2 Multiplex Real-time RT-PCR
510(k)
Gen-Probe, Inc. (Prodesse) San Diego, CA
ProFast+ assay3
Respiratory virus panel
Gen-Probe, Inc. (Prodesse) San Diego, CA
ProParaFlu+™ Assay2 Multiplex Real-time RT-PCR
510(k)
Gen-Probe, Inc. San Diego, CA
Procleix® WNV Assay Real-time PCR 510(k) West Nile for blood donations
Roche Molecular Diagnostics Pleasanton, CA
COBAS® TaqScreen WNV TC, TMA, HPA
510(k)
1Viruses include: three types of Influenza A, a strain of influenza B, adenovirus, respiratory syncytial virus A and B, Metapneumovirus, Parainfluenzas 1, 2, and 3, and rhinovirus. 2Viruses include: influenza A and B viruses and respiratory syncytial virus
3Viruses include: seasonal A/H1, seasonal A/H3, and 2009 H1N1
MOLECULAR DIAGNOSTIC TESTS - HUMAN TEST MANUFACTURER TEST NAME METHOD REGULATORY
ROUTE FOR PREMARKET
REVIEW
B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Abbott Molecular, Inc. Des Plaines, IL
CEP®12 DNA Probe Kit FISH 510(k)
Bladder Cancer - Initial diagnosis of bladder cancer in patients with hematuria and monitoring tumor recurrence of bladder cancer
Abbott Molecular, Inc. Des Plaines, IL
UroVysion® (also see under Systems below: BioView Duet Scanning System)
FISH PMA
Agendia, Amsterdam, The Netherlands
MammaPrint Microarray analysis
510(k) Breast Cancer - Determination of the likelihood of metastasis
Veridex, LLC Warren, NJ
GeneSearch™ BLN Test Real-time RT-PCR
PMA
Breast Cancer - Detection of amplifications and deletions of the TOP2A gene
Dako Denmark A/S Glostrup, Denmark DK-2600
TOP2A FISH pharmDx™ Kit FISH on FFPE breast tissue
PMA
Chromosome 8 Enumeration (CML, AML, MPD, MDS)
Abbott Molecular, Inc. Des Plaines, IL
CEP®8 DNA Probe Kit FISH 510(k)
Celera Diagnostics Alameda, CA
Cystic Fibrosis Genotyping Assay Multiplex PCR, OLA and electrophoresis
510(k)
Hologic, Inc. (Third Wave Technologies) Bedford, MA
InPlex™ CF Molecular Test Invader® Chemistry
510(k)
Luminex Molecular Diagnostics Toronto, Canada
Tag-It™ Mutation Detection Kit CFTR 40+4
PCR, ASPE, Tag sorting
de novo 510(k)
Luminex Molecular Diagnostics Toronto, Canada
XTag Cystic Fibrosis 39 Kit v2 PCR, ASPE, Tag sorting
510(k)
Luminex Molecular Diagnostics Toronto, Canada
XTag Cystic Fibrosis 60 Kit v2 PCR, ASPE, Tag sorting
510(k)
Cystic Fibrosis
Nanosphere, Inc. Verigene® CFTR Nucleic Acid Test Multiplex Gold 510(k)
Northbrook, IL and CFTR POLYT Nucleic Acid Test (also see under Systems below: Verigene® System)
Nanoparticle Probes
Osmetech Molecular Diagnostics, Pasadena, CA
eSensor® Cystic Fibrosis Carrier Detection System (also see under Systems below: eSensor® 4800 System)
PCR, Probe Hybridization
510(k)
Osmetech Molecular Diagnostics, Pasadena, CA
eSensor® Cystic Fibrosis Genotyping Test on eSensor XT-8 (also see under Systems below: eSensor® XT-8 System)
PCR, Probe Hybridization
510(k)
AutoGenomics, Inc. Carlsbad, CA
INFINITI™ 2C9 & VKORC1 Multiplex Assay for Warfarin (also see under Systems below: INFINITI™ Analyzer)
PCR and Detection Primer Extension
510(k)
AutoGenomics, Inc. Carlsbad, CA
INFINITI™ CYP2C19 Assay [for Plavix] (also see under Systems below: INFINITI™ Analyzer)
PCR and Detection Primer Extension
510(k)
Hologic, Inc. (Third Wave Technologies) Bedford, MA
Invader® UGT1A1 Molecular Assay
Invader® Chemistry
510(k)
Nanosphere, Inc. Northbrook, IL
Verigene® Warfarin Metabolism Nucleic Acid Test (also see under Systems below: Verigene® System)
Multiplex Gold Nanoparticle Probes
510(k)
Osmetech Molecular Diagnostics, Pasadena, CA
eSensor Warfarin Sensitivity Test (also see under Systems below: eSensor® XT-8 System)
PCR, Probe Hybridization
510(k)
ParagonDx, LLC Morrisville, NC
Gentris Rapid Genotyping Assay -CYP2C9 & VKORC1
Real-time PCR 510(k)
Roche Diagnostics Pleasanton, CA
AmpliChip™ Cytochrome P450 Genotyping Test (also see under Systems below: Affymetrix GCS 3000Dx Instrumentation System)
Microarray 510(k)
Drug metabolizing Enzymes
TrimGen Corp Sparks, MD
eQ-PCR™ LC Warfarin Genotyping Kit
Real-time PCR 510(k)
AutoGenomics, Inc. Carlsbad, CA
INFINITI™ System Assay for Factor II (also see under Systems below: INFINITI™ Analyzer)
PCR and Detection Primer Extension
510(k)
Nanosphere, Inc. Northbrook, IL
Verigene® F2 Nucleic Acid Test (also see under Systems below: Verigene® System)
Multiplex Gold Nanoparticle Probes
510(k)
Factor II (prothrombin) (single assay)
Roche Diagnostics Pleasanton, CA
Factor II (prothrombin) G20210A kit (also see under Systems below: LightCycler Instrument v. 1.2)
Real-time PCR 510(k)
AutoGenomics, Inc. Carlsbad, CA
INFINITI™ System Assay for Factor V (also see under Systems below: INFINITI™ Analyzer)
PCR and Detection Primer Extension
510(k)
Nanosphere, Inc. Northbrook, IL
Verigene® F5 Nucleic Acid Test (also see under Systems below: Verigene® System)
Multiplex Gold Nanoparticle Probes
510(k)
Factor V Leiden (single assay)
Roche Diagnostics Pleasanton, CA
Factor V Leiden kit (also see under Systems below: LightCycler Instrument v. 1.2)
Real-time PCR 510(k)
AutoGenomics, Inc. Carlsbad, CA
INFINITI™ System Assay for Factor II & Factor V (also see under Systems below: INFINITI™ Analyzer)
PCR and Detection Primer Extension
510(k)
Cepheid Sunnyvale, CA
Xpert™ Hemosil Factor II & Factor V Assay (also see under Systems below: GeneXpert™ Real-time PCR System )
Real-time PCR 510(k)
Factor II (Prothrombin) and Factor V Leiden (combined assay)
Nanosphere, Inc. Northbrook, IL
Verigene® F5/F2 Nucleic Acid Test (also see under Systems below: Verigene® System)
Multiplex Gold Nanoparticle Probes
510(k)
Factor II (Prothrombin), Factor V Leiden and MTHFR
Nanosphere, Inc. Northbrook, IL
Verigene® F5/F2/MTHFR Nucleic Acid Test (also see under Systems below: Verigene® System)
Multiplex Gold Nanoparticle Probes
510(k)
Heart Transplant Recipients XDx, Inc. AlloMap® Molecular Expression Quantitative 510(k)
- Identification of the potential risk for transplant rejection
Brisbane, CA Testing Real-time PCR
Abbott Molecular, Inc. Des Plaines, IL
PathVysion® HER-2 DNA Probe kit (also see under Systems below: Vysis AutoVysion™ System)
FISH PMA
Dako Denmark A/S Glostrup, Denmark DK-2600
Her2 FISH pharmDx™ Kit FISH on FFPE breast tissue
PMA
HER-2 Status
Invitrogen Carlsbad, CA
SPOT-Light HER2 CISH kit Chromogenic in situ hybridization
PMA
Biotest Diagnostics Corp. Denville, NJ
Biotest HLA SSP PCR 510(k)
Biotest Diagnostics Corp. Denville, NJ
Biotest DQB-ELPHA Enzyme linked DNA Probe Hybridization