Silver Spring, MD – The U.S. Food and Drug Administration (FDA) announced Tuesday, March 9th, 2021 that the following actions taken in its ongoing response effort to the COVID-19 Coronavirus 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 Coronavirus 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.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to CAMA Wellness Center/IodoRios Company, LLC for selling an unapproved product with fraudulent COVID-19 Coronavirus claims. The company sells a hand wipe product, and misleadingly represents the product can prevent or treat COVID-19 Coronavirus in people.
The FDA requested that CAMA Wellness Center/IodoRios Company, LLC take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 Coronavirus. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.
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.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.
