U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |


(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
  • On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
  • On Friday the FDA issued an EUA to Adaptive Biotechnologies for its T-Detect COVID Test. The T-Detect COVID Test analyzes DNA from a patient’s T cells (white blood cells) to aid in identifying people with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. The test should be used together with a clinical examination and a patient’s medical history. Negative results do not rule out acute or current SARS-CoV-2 infection.
  • Testing updates:
As of today, 340 tests and sample collection devices are authorized by the FDA under EUAs. These include 253 molecular tests and sample collection devices, 72 antibody and other immune response tests and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, one OTC at-home antigen test and one OTC molecular test.