Food and Drug Administration COVID-19 Updates

The FDA authorized the first serology, or antibody, test where the results of a new independent validation effort by the U.S. Government provided the scientific evidence used to support the authorization. The testing was performed at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The results are among the first to come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC), and Biomedical Advanced Research and Development Authority (BARDA) to evaluate certain serological tests. Essential samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases (NIAID), the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.

Diagnostics update to date:

• During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting EUA (Emergency Use Authorizations) requests to the FDA for tests that detect the virus.
• To date, the FDA has issued 58 individual EUAs for test kit manufacturers and laboratories. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
• The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.