- 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 COVID-19 vaccines so everyone can see it for themselves. Read the full article: Learn More About COVID-19 Vaccines From the FDA.
- Testing updates:
- As of today, 348 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 258 molecular tests and sample collection devices, 74 antibody and other immune response tests, and 16 antigen tests. There are 42 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Kim DiFonzo