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Current Molecular and Antigen Tests with FDA EUA Status

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Molecular-based Tests: main page

We have compiled a list of commercial and laboratory-developed tests that have received FDA Emergency Use Authorization.

This page was last updated on October 16, 2020.

Commercial tests

Download the complete list of commercial tests (xlsx). Included in the complete list are sensitivity and specificity measures, specimens required, target genes, test details, and manufacturing capabilities (if provided).

Test Manufacturer (linked)Date of EUA Issuance (linked)Type of Test
Quidel Corporation10/2/2020Rapid Antigen Test
Thermo Fisher Scientific10/9/2020 (original 3/13/2020)rRT-PCR
Spectrum Solutions LLC10/8/2020saliva collection only
Access Bio, Inc.10/8/2020Rapid Antigen Test
GenMark Diagnostics, Inc.10/7/2020multiplex rRT-PCR, electrochemical detection
Seasun Biomaterials, Inc.10/5/2020RT-LAMP
BioFire Diagnostics, LLC10/2/2020nested multiplex rRT-PCR
Clear Labs, Inc.9/23/2020rRT-PCR and NGS
Becton, Dickinson, and Company9/21/2020(original 4/8/2020)rRT-PCR
Becton, Dickinson, and Company9/21/2020 (original 4/2/2020)rRT-PCR
ScienCell Research Laboratories9/21/2020 (original was 4/3/2020)rRT-PCR
Quadrant Biosciences, Inc.9/22/2020rRT-PCR
Vela Operations Singapore Pte. Ltd9/22/2020rRT-PCR
Cepheidupdated 9/21/2020 (original 3/20/2020)rRT-PCR
Quest Diagnostics9/21/2020 (original 3/17/2020)rRT-PCR
KimForest Enterprise Co., Ltd.9/21/2020rRT-PCR
BioRad Laboratories, Inc9/18/2020 (original 5/1/2020)digital droplet rRT-PCR
GK Pharmaceuticals Contract Manufacturing Operations9/18/20rRT-PCR
Abbott Diagnostics Scarborough9/17/2020 amended, 3/27/2020 originalLAMP
Visby Medical, Inc.9/16/2020rRT-PCR
Hologic, Inc.9/15/2020 amended, 5/14/2020 original Dual Kinetic Assay (DKA) 
Roche Molecular Systems, Inc.9/15/2020rRT-PCR, multiplexed
Kaiser Permanente Mid-Atlantic States9/9/2020, original 6/13/2020N/A
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.9/9/2020rRT-PCR
BilliontoOne, Inc. 9/4/2020Sequencing
Roche Molecular Systems, Inc.9/3/2020rRT-PCR, multiplexed
Bioeksen R&D Technologies Ltd9/2/2020rRT-PCR
Detectachem Inc9/1/2020RT-LAMP
OPTOLANE Technologies, Inc.9/1/2020rRT-PCR
T2 Biosystems, Ltd8/31/2020qualitative T2 magnetic resonance
Mammoth Biosciences, Inc8/31/2020RT-LAMP
Fluidigm Corporation8/25/2020rRT-PCR
Abbott Diagnostics Scarborough, Inc.8/26/2020Rapid Antigen Test
LumiraDx UK Ltd.8/18/2020Antigen
ZhuHai Sinochips Bioscience Co., Ltd8/17/2020rRT-PCR
Biomeme, Inc.8/11/2020rRT-PCR
LumiraDx UK Ltd.8/11/2020non-isothermal nucleic acid amplification (qSTAR)
Vela Operations Singapore Pte Ltd.8/5/2020rRT-PCR
Xiamen Zeesan Biotech Co., Ltd.7/31/2020rRT-PCR
Jiangsu CoWin Biotech Co., Ltd.7/24/2020rRT-PCR
DiaCarta, Inc.7/21/2020rRT-PCR
Quest Diagnostics7/15/2020Observed home collection
Quest Diagnostics7/15/2020Observed home collection
Quest Diagnostics7/15/2020Observed home collection
Kogene Biotech Co, Ltd.7/13/2020rRT-PCR
Trax Management Services/Phoenix Dx7/13/2020rRT-PCR
BioSewoom, Inc.7/9/2020rRT-PCR
Enzo Life Sciences, Inc. 7/7/2020rRT-PCR
Access Bio, Inc.7/7/2020rRT-PCR
Centers for Disease Control and Prevention (CDC)7/2/2020rRT-PCR
Becton, Dickinson and Company (BD)7/2/2020Antigen (chromatographic digital immunoassay)
TNS Co., Ltd. (Bio TNS)6/30/2020rRT-PCR
The Kroger Co.6/30/2020At-home collection kit
PreciGenome LLC6/25/2020rRT-dPCR
Plexbio, Inc.6/25/2020rRT-PCR
Gencurix, Inc.6/23/2020rRT-PCR
3B Blackbio Biotech India Ltd6/18/2020rRT-PCR
Jiangsu Bioperfectus Technologies Co., Ltd6/18/2020rRT-PCR
Applied Biocode, Inc.6/15/2020rRT-PCR
RTA Laboratories Biological Products Pharmaceutical and Machinery Industry6/12/2020rRT-PCR
Tide Laboratories, LLC6/10/2020rRT-PCR
TBG Biotechnology Corp.6/10/2020rRT-PCR
Cue Health Inc.6/10/2020RT-LAMP
Illumina, Inc.6/9/2020Next Generation Sequencing (NGS)
ChromaCode6/9/2020rRT-PCR
Euroimmun US6/8/2020rRT-PCR
Genetron Health (Beijing) Co., Ltd.6/5/2020rRT-PCR
Phosphorus Diagnostics LLC6/4/2020rRT-PCR
Gravity Diagnostics6/1/2020rRT-PCR
PrivaPath Diagnostics, Inc.5/28/2020Self-collection of sample
dba SpectronRx5/22/2020rRT-PCR
BioCore Co., Ltd.5/21/2020rRT-PCR
SolGent Co., Ltd.5/21/2020rRT-PCR
Seasun Biomaterials, Inc.5/21/2020RT-LAMP
P23 Labs, LLC.5/21/2020rRT-PCR
Quidel Corporation5/18/2020rRT-PCR
Fulgent Therapeutics, LLC5/15/2020rRT-PCR
GeneMatrix, Inc.5/14/2020rRT-PCR
Applied DNA Sciences Inc.5/13/2020rRT-PCR
1drop Inc.5/11/2020rRT-PCR
Abbott Molecular5/11/2020rRT-PCR
Quidel Corporation5/8/2020Antigen
Gnomegen LLC5/8/2020rRT-PCR
Zymo Research Corporation5/7/2020rRT-PCR
OPTI Medical Systems5/6/2020rRT-PCR
Sherlock Biosciences, Inc5/6/2020CRISPR/RT-LAMP
BioMérieux SA5/6/2020rRT-PCR
Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)5/5/2020rRT-PCR
Sansure Biotech Inc. 5/4/2020rRT-PCR
BioFire Diagnostics, LLC5/1/2020rRT-PCR
Rheonix, Inc.4/29/2020rRT-PCR
LabGenomics Co, Ltd4/29/2020rRT-PCR
SEASUN Biomaterials4/27/2020rRT-PCR
SD Biosensor, Inc4/23/2020rRT-PCR
altona Diagnostics GmbH4/22/2020rRT-PCR
Covance/Seegene Inc4/21/2020rRT-PCR
Trax Management Services/Phoenix Dx4/20/2020rRT-PCR
OSANG Healthcare4/18/2020rRT-PCR
Fosun Pharma USA, Inc4/17/2020rRT-PCR
GenoSensor LLC4/16/2020rRT-PCR
Curative, Inc.4/16/2020rRT-PCR
Maccura Biotechnology, LLC4/15/2020rRT-PCR
Atila Biosystems, Inc4/10/2020Isothermal amplification (OMEGA), patented
DiaCarta, Inc4/8/2020rRT-PCR
InBios International4/7/2020rRT-PCR
Gnomegen Diagnostics4/6/2020rRT-PCR
Luminex Molecular Diagnostics4/3/2020rRT-PCR
Co-Diagnostics, Inc.4/3/2020rRT-PCR
Ipsum Diagnostics, LLC4/1/2020rRT-PCR
NeuMoDx Molecular, Inc.3/30/2020rRT-PCR
Qiagen3/30/2020rRT-PCR
Luminex Molecular Diagnostics3/27/2020rRT-PCR
BGI Genomics Ltd.3/26/2020rRT-PCR
PerkinElmer3/24/2020rRT-PCR
BioFire Defense LLC3/23/2020rRT-PCR
Mesa Biotech3/23/2020PCR and lateral flow
PrimerDesign Ltd.3/20/2020rRT-PCR
DiaSorin Diagnostics3/19/2020rRT-PCR
GenMark Diagnostics3/19/2020rRT-PCR
Abbott Molecular3/18/2020rRT-PCR
Quidel Corporation3/17/2020rRT-PCR
Hologic, Inc.3/16/2020rRT-PCR
Roche Molecular Systems, Inc.3/12/2020rRT-PCR
Wadsworth Center, NYSDOH2/29/2020rRT-PCR
Centers for Disease Control and Prevention2/4/2020rRT-PCR

 

Laboratory-developed tests

Download the complete list of laboratory-developed tests (xlsx). Included in the complete list are sensitivity and specificity measures, specimens required, target genes, and test details.

LDT DeveloperDate of EUA IssuanceType of Test
UCLA10/6/2020NGS
Cuur Diagnostics10/2/2020 (original 8/26/2020)rRT-PCR
Tempus Labs, Inc.10/1/2020rRT-PCR
Aeon Global Health9/30/2020rRT-PCR
Alimetrix, Inc.9/30/2020rRT-PCR
Centogene US, LLC9/29/2020rRT-PCR
Akron Children's Hospital9/29/2020rRT-PCR
National Jewish Health9/29/2020rRT-PCR, MALDI-TOF
Avellino Lab USA, Inc.3/25/2020rRT-PCR
Assurance Scientific Laboratories8/19/2020 (original) 5/15/2020rRT-PCR
Gravity Diagnostics, LLC9/21/2020 (original 6/1/2020)rRT-PCR
Acupath Laboratories, Inc.9/21/2020 (original 6/29/2020)rRT-PCR
Boston Heart Diagnostics9/2/2020 (original 7/16/2020)rRT-PCR
Eli Lilly and Company9/21/2020 (original 7/27/2020)rRT-PCR
Ethos Laboratories9/21/2020 (original 8/3/2020)At-home collection, rRT-PCR and MALDI-TOF
Exact Sciences Laboratories9/21/2020 (original 5/22/2020)rRT-PCR
LabCorp9/18/2020 (original 3/16/2020)rRT-PCR
Infinity BiologiX LLC9/18/20, originally 4/10/20rRT-PCR
Color Genomics9/14/2020 amended, 8/31/2020 originalAt-home collection kit
Verily Life Sciences9/8/20rRT-PCR, pooling
MiraDx8/31/20rRT-PCR
BayCare Laboratories, LLC8/31/20rRT-PCR
DxTerity Diagnostics, Inc.8/28/20rRT-PCR
Patients Choice Laboratories, LLC8/28/20rRT-PCR
QDx Pathology Services8/25/2020At-home collection  
Texas Department of State Health Services, Laboratory Services Section8/21/2020rRT-PCR
DxTerity Diagnostics, Inc.8/21/2020rRT-PCR
Guardant Health, Inc.8/21/2020rRT-PCR
Yale School of Public Health, Department of Epidemiology of Microbial Diseases8/15/2020rRT-PCR
Pro-Lab Diagnostics8/13/2020RT-LAMP
Solaris Diagnostics8/10/2020rRT-PCR
Alpha Genomix Laboratories8/10/2020rRT-PCR
George Washington University Public Health Laboratory8/7/2020rRT-PCR
Helix OpCo, LLC8/6/2020NGS
Wren Laboratories 8/3/2020rRT-PCR
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute8/3/2020rRT-PCR
Poplar Healthcare8/3/2020transcription mediated amplification (TMA)
ISPM Labs, LLC dba Capstone Healthcare8/3/2020rRT-PCR
University of California San Diego Health7/31/2020rRT-PCR
Clinical Reference Laboratory, Inc.7/30/2020rRT-PCR
Sandia National Laboratories7/27/2020rRT-PCR
Access Genetics, LLC.7/17/2020rRT-PCR
Compass Laboratory Services, LLC.7/13/2020rRT-PCR
Boston Medical Center7/10/2020rRT-PCR
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin7/9/2020RT-LAMP
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard7/8/2020rRT-PCR
Gene by Gene7/7/2020rRT-PCR
Laboratorio Clinico Toledo7/6/2020rRT-PCR
CENTOGENE US, LLC7/1/2020rRT-PCR
Psomagen, Inc.6/30/2020rRT-PCR
LifeHope Labs6/2/2020rRT-PCR
Inform Diagnostics, Inc.6/26/2020rRT-PCR
Diagnostic Solutions Laboratory, LLC6/25/2020rRT-PCR
University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory6/24/2020rRT-PCR
HealthQuest Esoterics6/23/2020rRT-PCR
University of Alabama Fungal Reference Lab6/23/2020 
The Ohio State University Wexner Medical Center6/18/2020rRT-PCR
Omnipathology Solutions Medical Corporation6/17/2020rRT-PCR
Cormeum Laboratory Services6/12/20rRT-PCR
Warrior Diagnostics, Inc.6/9/20rRT-PCR
Nebraska Medicine Clinical Laboratory6/4/20rRT-PCR
Aspirus Reference Laboratory6/1/20rRT-PCR
CSI Laboratories6/1/20rRT-PCR
Exact Sciences Laboratories5/22/20rRT-PCR
Express Gene LLC (dba Molecular Diagnostics Laboratory)5/22/20rRT-PCR
Avera Institute for Human Genetics5/22/20rRT-PCR
Color Genomics5/18/20RT-LAMP
OneHealth Laboratories, LLC5/13/20rRT-PCR
Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine5/13/20rRT-PCR
Columbia University Laboratory of Personalized Genomic Medicine5/12/20rRT-PCR
Biocollections Worldwide, Inc.5/7/20rRT-PCR
UTMG Pathology Laboratory5/3/20rRT-PCR
Altru Diagnostics, Inc.4/30/20rRT-PCR
Biocerna4/28/20rRT-PCR
Nationwide Children’s Hospital4/27/20rRT-PCR
Ultimate Dx Laboratory4/24/20rRT-PCR
AIT Laboratories4/24/20rRT-PCR
Southwest Regional PCR Laboratory LLC. dba MicroGen DX4/23/20rRT-PCR
Diatherix Eurofins Laboratory4/22/20rRT-PCR
Mayo Clinic Laboratories, Rochester, MN4/20/20rRT-PCR
Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory4/15/20rRT-PCR
CirrusDx Laboratories4/15/20rRT-PCR
Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital4/14/20rRT-PCR
Exact Sciences Laboratories4/14/20rRT-PCR
Integrity Laboratories4/13/20rRT-PCR
Pathology/Laboratory Medicine Lab of Baptist Hospital Miami4/13/20rRT-PCR
Orig3n, Inc.4/10/20rRT-PCR
Specialty Diagnostic (SDI) Laboratories4/10/20rRT-PCR
University of North Carolina Medical Center4/10/20rRT-PCR
Stanford Health Care Clinical Virology Laboratory4/8/20rRT-PCR
Viracor Eurofins Clinical Diagnostics4/6/20rRT-PCR
Massachusetts General Hospital4/3/20rRT-PCR
Diagnostic Molecular Laboratory – Northwestern Medicine4/2/20rRT-PCR
Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia4/2/20rRT-PCR
Yale New Haven Hospital, Clinical Virology Laboratory3/31/20rRT-PCR

 

 

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