Coronavirus (COVID-19) Update: December 10, 2021

FDA News Release

• For Immediate Release: December 10, 2021

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

• On December 9, 2021, the FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information. The update added new information about the Meridian Bioscience, Inc. Revogene SARS-CoV-2 test, including the impact of the SARS-CoV-2 omicron variant on test performance. Since the Revogene SARS-CoV-2 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. Meridian Biosciences has not yet distributed this test and does not intend to distribute this test, within or outside the United States, until this issue is resolved.
• Testing updates:
  • As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 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 703 revisions to EUA authorizations.