FDA Approved Coronavirus Tests
COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION (As of April 1, 2020) Yesterday, North Carolina-based Cellex’s qSARS-CoV-2 IgG/IgM Rapid Test became the first coronavirus serology test to receive FDA EUA clearance. (A) Cleared under FDA “Policy A,” meaning it can be performed only by high-complexity lab that developed and validated test Date Manufacturer(s) Test Receiving EUA Feb 4 CDC 2019 Real Time RT-PCR Diagnostic Test Panel March 2 New York State Wadsworth Center, New York State Department of Public Health’s New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel March 13 Roche Cobas SARS-CoV-2 Test March 15 Thermo Fisher Scientific TaqPath COVID-19 Combo Kit for qualitative detection of SARS-CoV-2 nucleic acid March 16 LabCorp COVID-19 RT-PCR test March 16 Hologic Panther Fusion SARS-CoV-2 assay for use on firm’s Panther Fusion system March 17 Quidel Lyra SARS-CoV-2, RT-qPCR assay for qualitative detection of nucleic acid from SARS-CoV-2 March 18 Abbott Abbott RealTime SARS-CoV-2 EUA run on firm’s PCR-based m2000 RealTime System March 19 Quest Diagnostics SARS-CoV-2 rRT PCR test March 19 GenMark Diagnostics ePlex SARS-CoV-2 Test run on firm’s ePlex system March 20 DiaSorin Molecular Simplexa COVID-19 Direct assay run on firm’s Liason MDX real-time PCR instrument March 21 Cepheid […]
COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION
(As of April 1, 2020)
Yesterday, North Carolina-based Cellex’s qSARS-CoV-2 IgG/IgM Rapid Test became the first coronavirus serology test to receive FDA EUA clearance.
(A) Cleared under FDA “Policy A,” meaning it can be performed only by high-complexity lab that developed and validated test
| Date | Manufacturer(s) | Test Receiving EUA |
| Feb 4 | CDC | 2019 Real Time RT-PCR Diagnostic Test Panel |
| March 2 | New York State | Wadsworth Center, New York State Department of Public Health’s New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel |
| March 13 | Roche | Cobas SARS-CoV-2 Test |
| March 15 | Thermo Fisher Scientific | TaqPath COVID-19 Combo Kit for qualitative detection of SARS-CoV-2 nucleic acid |
| March 16 | LabCorp | COVID-19 RT-PCR test |
| March 16 | Hologic | Panther Fusion SARS-CoV-2 assay for use on firm’s Panther Fusion system |
| March 17 | Quidel | Lyra SARS-CoV-2, RT-qPCR assay for qualitative detection of nucleic acid from SARS-CoV-2 |
| March 18 | Abbott | Abbott RealTime SARS-CoV-2 EUA run on firm’s PCR-based m2000 RealTime System |
| March 19 | Quest Diagnostics | SARS-CoV-2 rRT PCR test |
| March 19 | GenMark Diagnostics | ePlex SARS-CoV-2 Test run on firm’s ePlex system |
| March 20 | DiaSorin Molecular | Simplexa COVID-19 Direct assay run on firm’s Liason MDX real-time PCR instrument |
| March 21 | Cepheid | Xpert Xpress SARS-CoV-2 point-of-care test |
| March 23 | Primerdesign | COVID-19 Genesig Real-Time PCR assay |
| March 24 | Mesa Biotech | Accula SARS-CoV-2 test |
| March 24 | BioMérieux | BioFire COVID-19 test run on firm’s BioFire FilmArray system |
| March 24 | PerkinElmer | New Coronavirus Nucleic Acid Detection Kit |
| March 25 | Quidel | Expanded EUA for Lyra SARS-CoV-2 assay |
| March 27 | BGI Americas (BGI Genomics US sub) | BGI Real-Time Fluorescent RT-PCR Kit |
| March 27 | Luminex | NxTag CoV Extended Panel |
| March 27 | Abbott | SARS-CoV-2 point-of-care test |
| March 30 | Qiagen | QiaStat-Dx Respiratory SARS-CoV-2 Panel, first “syndromic” testing product to be deployed in US |
| March 30 | NeuMoDxt | NeuMoDx SARS-CoV-2 Test Strip for use on NeuMoDx 288 Molecular + NeuMoDx 96 Molecular systems |
| April 1 | Yale New Haven Hospital Clinical Virology Laboratory | SARS-CoV-2 RT-PCR test(A) |
| April 2 | Cellex | qSARS-CoV-2 IgG/IgM Rapid Test, first coronavirus serology test to get EUA clearance |
| April 2 | Ipsum Diagnostics | COV-19 IDx, an RT-PCR-based SARS-CoV-2 test |
(A) Cleared under FDA “Policy A,” meaning it can be performed only by high-complexity lab that developed and validated test
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