Industry updates: FDA Emergency Use Authorizations for novel coronavirus diagnostic testing

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On February 4, 2020, the FDA issued a EUA for the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV (RT)-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens. This EUA was re-issued in its entirety on March 15, 2020 to reflect a number of amendments including changes to the intended use and primer and probe materials. As of March 30, the FDA issued EUAs to Thermo-Fisher, Roche Molecular Systems, Hologic, Laboratory Corporation of America (LabCorp), Quidel, Quest Diagnostics, Abbot Molecular, DiaSorin Molecular, GenMark Diagnostics, Primerdesign, Cepheid, BioFire Defense, Mesa Biotech, PerkinElmer, Avellino Lab USA, BGI Genomics Co., Abbott Diagnostics Scarborough, and Luminex Molecular Diagnostics.
Many commercial and healthcare system/academic laboratories have notified the FDA that they have validated their own COVID-19 test and have started patient testing as set forth in Section IV.A of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not yet reviewed these laboratories’ validation of tests offered under this policy or issued EUAs for these laboratories' tests. Laboratories that have submitted notifications to FDA include AdventHealth, Cleveland Clinic, Eli Lilly Clinical Diagnostics, Genesys Diagnostics, Henry Ford Halth System, Johns Hopkins Medical Microbiology Laboratory at Johns Hopkins Hospital, Quest Diagnostics Infectious Disease and Xymbio.
FDA has recently issued several EUAs for rapid point-of-care diagnostic tests.  Mesa Biotech received EUA for its Accula SARS-Cov-2 Test on March 23.  The test uses throat and nasal swabs collected at the point-of-care, and clams that results are available in 30 minutes. The Cepheid Xpert Xpress SARS-CoV-2 test, which received EUA on March 21 claims to detect the novel virus within “approximately 45 minutes with less than a minute of hands on time to prepare the sample.” Cepheid intends to roll-out by March 30. Abbot’s ID NOW COVID-19 test, which received EUA on March 27, claims to deliver positive results in as little as five minutes and negative results in 13 minutes.
The EUAs for the point-of-care tests permit their use in both high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings outside of a clinical laboratory, such as in temporary screening locations, doctor’s office labs and nursing homes.
Notably, FDA has warned consumers that it has not authorized any at-home COVID-19 test or home-collection kit. The policies outlined in the Policy for Diagnostic Tests for Coronavirus Disease-2019 specifically exclude at-home testing, including self-collection of samples to be sent to a clinical laboratory. The FDA did, however, update its FAQs on Diagnostic Testing for SARS-CoV-2 regarding specimen collection for COVID-19 testing to permit “self-collection of specimens at collection sites” for symptomatic patients with “nasal swabs . . . that access just the front of the nose rather than the depth of the nasal cavity.”
In addition to granting EUAs to commercial test manufacturers and clinical laboratories, FDA announced on March 12, 2020 that it would exercise enforcement discretion and would not object to the New York State Department of Health (NYSDOH) authorizing certain laboratories in New York to begin patient testing after validating their tests and notifying the NYSDOH. Under NYSDOH’s approach, laboratories will provide validation data to NYSDOH within 15 days in lieu of pursuing an Emergency Use Authorization (EUA) with the FDA.
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