Infectious Disease Tests - Bacterial

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. ().

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)
Candida albicans and Candida spp. / AdvanDx
Woburn, MA / C. albicans PNA FISH / PNA FISH / 510(k)
AdvanDx
Woburn, MA / Yeast Traffic Light PNA FISH™1 / PNA FISH / 510(k)
Clostridium difficile / 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)
Gen-Probe, Inc.
(Prodesse)
San Diego, CA / ProGastro™ Cd Assay / Multiplex
Real-time PCR / 510(k)
Chlamydia trachomatis detection (single organism) / BD Diagnostic Systems
Sparks, MD / BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay / SDA / 510(k)
Gen-Probe, Inc. San Diego, CA / APTIMA CT® Assay / TC, TMA, DKA / 510(k)
Gen-Probe, Inc. San Diego, CA / PACE® 2 CT
Probe Competition Assay
(Ct-confirmation test) / HPA / 510(k)
Qiagen, Inc.
Germantown, MD / HC2® CT ID / Hybrid Capture / 510(k)
Roche Molecular Diagnostics Pleasanton, CA / AMPLICOR® CT/NG Test for Chlamydia trachomatis / PCR / 510(k)
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AMPLICOR® CT/NG Test for Chlamydia trachomatis2 / PCR / 510(k)
Neisseria gonorrhoeae detection (single organism) / BD Diagnostic Systems
Sparks, MD / BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay / SDA / 510(k)
Gen-Probe, Inc. San Diego, CA / APTIMA® GC Assay / TC, TMA, DKA / 510(k)
Gen-Probe, Inc. San Diego, CA / PACE® 2 GC
Probe Competition Assay
(GC-confirmation test) / HPA / 510(k)
Qiagen, Inc.
Germantown, MD / HC2® GC ID / Hybrid Capture / 510(k)
Roche Molecular Diagnostics Pleasanton, CA / AMPLICOR® CT/NG Test for Neisseria gonorrhoeae / PCR / 510(k)
Roche Molecular Diagnostics Pleasanton, CA / COBAS AMPLICOR® CT/NG Test for Neisseria gonorrhoeae1 / PCR / 510(k)
Chlamydia trachomatis and Neisseria gonorrhoeae detection / 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: TIGRISÒ DTSÔ System) / TC, TMA, DKA / 510(k)
Gen-Probe, Inc. San Diego, CA / PACE® 2C CT/GC / HPA / 510(k)
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)
Group B Streptococci detection / 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)
Gen-Probe, Inc. San Diego, CA / Group B AccuProbe® / HPA / 510(k)
MRSA for Staphylococcus aureus - Screening assay / 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)
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)
MRSA for Staphylococcus aureus -Diagnostic assay for positive blood cultures / BD Diagnostics - GeneOhm
San Diego, CA / GeneOhm StaphSR / Real-time PCR / 510(k)
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.

3Campylobacter spp., Enterococcus spp., Group B Streptococcus, Haemophilus influenzae, Neisseria gonorrhoeae, Streptococcus pneumoniae, Staphylococcus aureus, Listeria monocytogenes, Group A Streptococcus, Mycobacterium avium, Mycobacterium intracellulare, Mycobacterium avium complex, Mycobacterium gordonae, Mycobacterium tuberculosis complex, Mycobacterium kansasii, Blastomyces dermatitidis, Coccidioides immitis, Crytococcus neoformans, Histoplasma capsulatum.

INFECTIOUS DISEASE TESTS - VIRAL

TEST / MANUFACTURER / TEST NAME / METHOD / Regulatory Route for Premarket Review
Avian Flu / Centers for Disease Control and Prevention / Influenza A/H5 / Real-time RT-PCR / 510(k)
Cytomegalovirus detection / bioMérieux, Inc. Durham, NC / CMV pp67 mRNA / NASBA / 510(k)
Gentech Diagnostics Pvt. Ltd.
New Delhi, India / Hybrid Capture® CMV DNA Test / Hybrid Capture with Chemi-luminescent detection / 510(k)
Qiagen, Inc.
Germantown, MD / HC1® CMV DNA Test / Hybrid Capture / 510(k)
Enterovirus detection / bioMérieux, Inc. Durham, NC / NucliSENS EasyQ® Enterovirus (also see under Systems below: NucliSENS EasyQ® System) / Real-time NASBA / 510(k)
Cepheid
Sunnyvale, CA / Xpert™ EV (also see under Systems below: GeneXpert™ Real-time PCR System ) / Real-time PCR / 510(k)
HBV Quantification / Abbott Molecular, Inc.
Des Plaines, IL / Abbott Real-time HCV (also see under Systems below: Abbott m2000™ [m2000sp + m2000rt]) / Real-time RT-PCR / PMA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® TaqMan® HBV Test, for use with the HighPure System / Real-time PCR / PMA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0 / Real-time PCR / PMA
HCV Qualitative detection / Gen-Probe, Inc. San Diego, CA
(distributed by Siemens Healthcare Diagnostics, Deerfield, IL) / VERSANT® HCV RNA / TMA / PMA
Roche Molecular Diagnostics Pleasanton, CA / AMPLICOR™ HCV Test, v2.0 / RT-PCR / PMA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AMPLICOR™ HCV Test, v2.0 / RT-PCR / PMA
HCV Quantification / Siemens Healthcare Diagnostics
Deerfield, IL / VERSANT® HCV RNA 3.0 Assay (bDNA) (also see under Systems below: VERSANT™ 440 Molecular System) / bDNA / PMA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AmpliPrep/
COBAS® TaqMan HCV Test (also see under Systems below: COBAS® AmpliPrep/COBASÒ TaqMan) / Real-time RT-PCR / PMA
Roche Molecular Diagnostics Pleasanton, CA / COBAS TaqMan HCV v2.0 / Real-time RT-PCR / 510(k)
HIV drug resistance testing / Celera Diagnostics Alameda, CA (distributed by Abbott Laboratories, Abbott Park, Il) / ViroSeq™ HIV-1 Genotyping System / Sequencing / 510(k)
Siemens Healthcare Diagnostics
Deerfield, IL / TruGene™ HIV-1 Genotyping and Open Gene DNA Sequencing System / Sequencing / 510(k)
HIV Quantification / Abbott Molecular, Inc.
Des Plaines, IL / Abbott Real-time HIV-1 (also see under Systems below: Abbott m2000™ [m2000sp + m2000rt]) / Real-time RT-PCR / PMA
bioMérieux, Inc. Durham, NC / NucliSens®HIV-1 QT / NASBA / PMA
Roche Molecular Diagnostics Pleasanton, CA / AMPLICOR HIV-1 MONITOR™ Test, v1.5 / RT-PCR / PMA
Roche Molecular Diagnostics Pleasanton, CA / COBAS AMPLICOR HIV-1 MONITOR™ Test, v1.5 / RT-PCR / PMA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AmpliPrep/
COBAS® TaqMan HIV-1 Test (also see under Systems below: COBAS® AmpliPrep/COBASÒ TaqMan) / Real-time RT-PCR / PMA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AmpliPrep/
COBAS® TaqMan HIV-1 Test, v.2.0 (also see under Systems below: COBAS® AmpliPrep/COBASÒ TaqMan) / Real-time RT-PCR (dual-target assay) / PMA
Siemens Healthcare Diagnostics
Deerfield, IL / VERSANT® HIV-1 RNA 3.0 Assay (bDNA) / bDNA / PMA
HBV/HCV/HIV for blood , blood component and tissue donations / BioLife Plasma Services, L.P.
Deerfield, IL 60015 / Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay / RT-PCR / BLA
BioLife Plasma Services, L.P.
Deerfield, IL 60015 / Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay / RT-PCR / BLA
Gen-Probe, Inc. San Diego, CA
(distributed by Chiron) / Procleix® HIV-1/HCV Assay (also see under Systems below: Procleix® Semi-Automated Instrument System) / TC, TMA, HPA / 510(k)
Gen-Probe, Inc. San Diego, CA
(distributed by Chiron) / Procleix® ULTRIO® Assay
(HIV-1, HCV and HBV) (also see under Systems below: Procleix® Semi-Automated Instrument System) / TC, TMA, HPA / 510(k)
National Genetics Institute Los Angeles, CA / UltraQual™ HCV RT-PCR Assay / RT-PCR / BLA
National Genetics Institute Los Angeles, CA / UltraQual™ HIV-1 RT-PCR Assay / RT-PCR / BLA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AmpliScreen™ HBV Test / PCR / BLA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AmpliScreen™ HCV Test, v2.0 / RT-PCR / BLA
Roche Molecular Diagnostics Pleasanton, CA / COBAS® AmpliScreen™ HIV-1 Test, v1.5 / RT-PCR / BLA
Roche Molecular Diagnostics Pleasanton, CA / 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)
Human Papillomavirus Testing / 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
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)
Respiratory virus panel / 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
Gen-Probe, Inc.
(Prodesse)
San Diego, CA / ProParaFlu+™ Assay2 / Multiplex
Real-time RT-PCR / 510(k)
West Nile for blood donations / Gen-Probe, Inc. San Diego, CA / Procleix® WNV Assay / Real-time PCR / 510(k)
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.