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 […]