FDA OKs another at-home, over-the-counter COVID-19 test

The FDA today announced that it issued emergency use authorization (EUA) for ACON Laboratories’ Flowflex COVID-19 home test.

Authorization of the antigen test should significantly increase the availability of rapid, at-home tests, director of FDA’s Center for Devices and Radiological Health Dr. Jeff Shuren said in a statement. The agency expects rapid, at-home testing capacity in the U.S. to double over the next several weeks, as ACON said it plans to produce more than 100 million tests per month, rising to 200 million per month by February 2022.

The FDA said that at-home COVID-19 diagnostics represent a high-priority for review, given their public health importance. Based on data provided for asymptomatic individuals, FDA said the ACON’s Flowflex home test does not require serial testing, meaning authorization can facilitate even greater access and testing capacity.

Additionally, the FDA issued a reminder that all tests can experience false-…

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