- For immediate release:
The US 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 (USA) to Twist Bioscience Corporation for its 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 specimens, such as swabs and nose or throat washes, from individuals who are suspect they have COVID. -19. This is the second full 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 for 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 the emergency use authorizations for COVID-19 vaccines for everyone to see for themselves. Read the full article: Learn more about the FDA’s COVID-19 vaccines.
- Upgrade testing:
- To date, 348 tests and sample collection devices are cleared by the FDA under Emergency Use Authorizations (US). These include 258 molecular tests and sample collection devices, 74 tests for antibody and other immune response tests, and 16 tests for antigens. There are 42 molecular clearances that can be used with samples collected at home. There is one home molecular prescription test, two home antigen prescription tests, one over-the-counter (OTC) home antigen test, and one over-the-counter molecular test.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use and medical devices for human use. and veterinarian. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating our nation’s tobacco products.