Coronavirus (COVID-19) Update: December 7, 2021

FDA News Release

• For Immediate Release: December 07, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information, including FDA recommendations for clinical laboratory staff and health care providers. The update also added new information about SARS-CoV-2 tests whose performance could be impacted by SARS-CoV-2 genetic mutations, specifically those found in the omicron variant, in patient samples. This includes a list of tests where viral mutations cause a specific detection pattern that may help to signal the presence of the omicron variant, but genetic sequencing would be needed to confirm. Since the tests on this list are designed to detect multiple genetic targets, it is expected these tests will continue to detect SARS-CoV-2 including when the omicron variant is present.
• The FDA also added the Tide Laboratories, LLC, DTPM COVID-19 RT-PCR Test to another list of impacted tests. Since the Tide Laboratories test is a single target test that targets a portion of the N-gene where deletions occur with the omicron variant, the test is expected to fail to detect the SARS-CoV-2 omicron variant. In the update, we include laboratories where the test is performed. To note, it is not believed to be used for high volume testing.
• Testing updates:
  • As of today, 425 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 294 molecular tests and sample collection devices, 90 antibody and other immune response tests and 41 antigen tests. There are 67 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
  • The FDA has authorized 22 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 702 revisions to EUA authorizations.