FDA Grants Emergency Use Authorization for OTC COVID-19 Test

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FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.

FDA issued an emergency use authorization to ACON Laboratories Flowflex COVID-19 Home Test, an over the counter COVID-19 antigen test, on Oct. 4th, 2021. According to a press release from the organization, this was done to increase rapid testing accessibility for the general public in the United States.

According to an FDA press release, the authorization of the new antigen test will double rapid at-home testing capacity in the US over the next several weeks. ACON plans to produce more than 100 million tests per month by the end of the year and will begin making 200 million per month by February 2022.

FDA has authorized more than 400 COVID-19 tests and sample collection devices, but most antigen tests for at-home use are authorized for serial testing or testing the same individual more than once within a few days. As a result of data provided concerning asymptomatic individuals, the ACON test does not require serial testing.


“We believe at-home diagnostic tests play a critical role in the fight against COVID-19,” FDA said in the press release. “We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans.”

Source: FDA