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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.

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
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
Kaiser Permanente Mid-Atlantic States6/13/2020 
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
Assurance Scientific Laboratories5/15/2020rRT-PCR
Hologic, Inc.5/14/2020Dual Kinetic Assay (DKA) 
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
Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University5/7/2020rRT-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
BioRad Laboratories, Inc5/1/2020digital droplet rRT-PCR
Rheonix, Inc4/29/2020rRT-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
Laboratory Corporation of America (LabCorp)4/20/2020rRT-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
Becton, Dickinson, and Company4/8/2020rRT-PCR
DiaCarta, Inc4/8/2020rRT-PCR
InBios International4/7/2020rRT-PCR
Gnomegen Diagnostics4/6/2020rRT-PCR
Luminex Molecular Diagnostics4/3/2020rRT-PCR
ScienCell Research Laboratories4/3/2020rRT-PCR
Co-Diagnostics, Inc.4/3/2020rRT-PCR
Becton, Dickinson, and Company4/2/2020rRT-PCR
Ipsum Diagnostics, LLC4/1/2020rRT-PCR
NeuMoDx Molecular, Inc.3/30/2020rRT-PCR
Qiagen3/30/2020rRT-PCR
Abbott Diagnostics Scarborough3/27/2020LAMP
Luminex Molecular Diagnostics3/27/2020rRT-PCR
BGI Genomics Ltd.3/26/2020rRT-PCR
Avellino Lab USA, Inc.3/25/2020rRT-PCR
PerkinElmer3/24/2020rRT-PCR
BioFire Defense LLC3/23/2020rRT-PCR
Mesa Biotech3/23/2020PCR and lateral flow
PrimerDesign Ltd.3/20/2020rRT-PCR
Cepheid3/20/2020rRT-PCR
DiaSorin Diagnostics3/19/2020rRT-PCR
GenMark Diagnostics3/19/2020rRT-PCR
Abbott Molecular3/18/2020rRT-PCR
Quidel Corporation3/17/2020rRT-PCR
Quest Diagnostics3/17/2020rRT-PCR
Hologic, Inc.3/16/2020rRT-PCR
Thermo Fisher Scientific, Inc. 3/13/2020rRT-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
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 Laboratories6/1/2020rRT-PCR
Exact Sciences Laboratories5/22/2020rRT-PCR
Express Gene LLC (dba Molecular Diagnostics Laboratory)5/22/2020rRT-PCR
Avera Institute for Human Genetics5/22/2020rRT-PCR
Color Genomics5/18/2020RT-LAMP
OneHealth Laboratories, LLC5/13/2020rRT-PCR
Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine5/13/2020rRT-PCR
Columbia University Laboratory of Personalized Genomic Medicine5/12/2020rRT-PCR
Biocollections Worldwide, Inc.5/7/2020rRT-PCR
UTMG Pathology Laboratory5/3/2020rRT-PCR
Altru Diagnostics, Inc.4/30/2020rRT-PCR
Biocerna4/28/2020rRT-PCR
Nationwide Children’s Hospital4/27/2020rRT-PCR
Ultimate Dx Laboratory4/24/2020rRT-PCR
AIT Laboratories4/24/2020rRT-PCR
Southwest Regional PCR Laboratory LLC. dba MicroGen DX4/23/2020rRT-PCR
Diatherix Eurofins Laboratory4/22/2020rRT-PCR
Mayo Clinic Laboratories, Rochester, MN4/20/2020rRT-PCR
Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory4/15/2020rRT-PCR
CirrusDx Laboratories4/15/2020rRT-PCR
Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital4/14/2020rRT-PCR
Exact Sciences Laboratories4/14/2020rRT-PCR
Integrity Laboratories4/13/2020rRT-PCR
Pathology/Laboratory Medicine Lab of Baptist Hospital Miami4/13/2020rRT-PCR
Orig3n, Inc.4/10/2020rRT-PCR
Specialty Diagnostic (SDI) Laboratories4/10/2020rRT-PCR
University of North Carolina Medical Center4/10/2020rRT-PCR
Stanford Health Care Clinical Virology Laboratory4/8/2020rRT-PCR
Viracor Eurofins Clinical Diagnostics4/6/2020rRT-PCR
Massachusetts General Hospital4/3/2020rRT-PCR
Diagnostic Molecular Laboratory – Northwestern Medicine4/2/2020rRT-PCR
Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia4/2/2020rRT-PCR
Yale New Haven Hospital, Clinical Virology Laboratory3/31/2020rRT-PCR

 

 

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