Coronavirus (COVID-19) Update: March 26, 2021

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…

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