- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On March 23, 2021, the FDA issued an emergency use authorization (EUA) to the Twist Bioscience Corporation for their SARS-CoV-2 NGS Assay. The SARS-CoV-2 NGS Assay is a next-generation sequencing (NGS) based test for the identification of SARS-CoV-2 RNA from respiratory samples, such as nose or throat swabs and washes, from people who are suspected of having COVID-19. This is the second whole genome sequencing diagnostic test for the qualitative detection of SARS-CoV-2 RNA authorized by the FDA. The test can be performed in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that meet the requirements to perform high-complexity testing.
- In a March 24 Consumer Update, the FDA answers common questions about COVID-19 vaccines. The FDA is publicly sharing information about the evidence behind emergency use authorizations for…