For immediate release:

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

  • On March 23, 2021, the FDA issued an emergency use authorization (USA) to Twist Bioscience Corporation for its SARS-CoV-2 NGS trial. The SARS-CoV-2 NGS assay is a state-of-the-art sequencing (NGS) test for the identification of SARS-CoV-2 RNA from respiratory samples, such as smears and washes of the nose or throat, from people suspected of having COVID – 19. This is the second complete 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 by the 1988 Clinical Laboratory Improvement Amendments (CLIA) that meet the requirements for conducting highly complex tests.
  • 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 the emergency use permits for COVID-19 vaccines so that everyone can see for themselves. Read the full article: Learn more about the FDA’s COVID-19 vaccines.
  • Testing updates:
    • As of today, 348 tests and sample collection devices are authorized by the FDA under emergency use authorization (EUAs). This includes 258 molecular tests and sample collection devices, 74 antibody tests and other immune response tests and 16 antigen tests. There are 42 molecular permits that can be used with samples collected at home. There is a home molecular prescription test, two home antigen prescription tests, an over-the-counter home antigen test (OTC) and an OTC molecular test.

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.

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