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Home 5 Articles 5 Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time

Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time

by | Apr 20, 2020 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

The US Food and Drug Administration (FDA) has taken a lot of heat for wasting precious time in responding to the COVID-19 emergency. While this criticism is fair, it is also true that the agency has made up for at least some of that lost time since getting its response strategy in order. In previous public health emergencies, approval for commercial laboratory tests to diagnose a pathogen has taken months, if not years. Eight weeks was the fastest on record. The first commercial test for COVID-19, from Roche, was approved just six weeks into the emergency. And since then literally dozens of new tests have received FDA Emergency Use Authorization (EUA), a total that grows literally every day. Here is the latest count as of April 17, 2020. COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology 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 […]

The US Food and Drug Administration (FDA) has taken a lot of heat for wasting precious time in responding to the COVID-19 emergency. While this criticism is fair, it is also true that the agency has made up for at least some of that lost time since getting its response strategy in order. In previous public health emergencies, approval for commercial laboratory tests to diagnose a pathogen has taken months, if not years. Eight weeks was the fastest on record. The first commercial test for COVID-19, from Roche, was approved just six weeks into the emergency. And since then literally dozens of new tests have received FDA Emergency Use Authorization (EUA), a total that grows literally every day. Here is the latest count as of April 17, 2020. COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology 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
April 2 Cellex qSARS-CoV-2 IgG/IgM Rapid Test (s)
April 2 Ipsum Diagnostics COV-19 IDx, an RT-PCR-based SARS-CoV-2 test
April 3 Becton Dickinson + BioGX Sample-Ready hospital SARS-CoV-2 assay for use on BD Max system
April 6 ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR Detection Kit
April 6 Co-Diagnostics Logix Smart Coronavirus COVID-19 Test
April 6 Luminex Aries SARS-CoV-2 Assay
April 6 Massachusetts General Hospital MGH SARS-CoV-2 assay
April 6 Infectious Disease Diagnostics Laboratory at Children’s Hospital of Philadelphia SARS-CoV-2 RT-PCR Test
April 6 Diagnostic Molecular Laboratory at Northwestern Medicine SARS-CoV-2 Assay
April 7 Gnomegen COVID-19 RT-Digital PCR Detection kit for diagnosing SARS-CoV-2
April 8 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 molecular assay
April 8 Becton Dickinson BD MAX ExK TNA-3 kit run on the BD Max system
April 9 Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 assay
April 9 DiaCarta QuantiVirus PCR diagnostic (Dx) test for COVID-19
April 13 Rutgers Clinical Genomics Laboratory First approved molecular COVID-19 test for use with saliva samples
April 13 University of North Carolina Medical Center UNC Health SARS-CoV-2 real-time RT-PCR test
April 13 Atila Biosystems iAMP COVID-19 Detection Kit
April 13 Specialty Diagnostic Laboratories Test for qualitative detection of a region in SARS-CoV-2 ORF1a/b gene
April 13 Orig3n Novel Coronavirus Test for qualitative detection of two regions in SARS-CoV-2 nucleocapsid gene
April 14 Integrity Labs Probe-based molecular test for SARS-CoV-2 detecting N1 and N2 targets from CDC Prevention assay kit
April 14 Baptist Hospital Miami Probe-based real-time RT-PCR assay detecting the CDC N2 target
April 15 Ortho Clinical Diagnostics Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators (s)
April 15 Chembio Diagnostics DPP COVID-19 serological point-of-care test and analyzer providing numerical readings for IgM and IgG antibody levels (s)
April 15 Boston Children's Hospital Childrens-Altona-SARS-CoV-2 assay
April 16 Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test (s)
April 16 Maccura Biotechnology Fluorescent PCR-based SARS-CoV-2 test kit
April 16 Hackensack University Medical Center CDI Enhanced COVID-19 test
April 16 CirrusDx Laboratory Assay detecting SARS-CoV-2 nucleocapsid gene

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