FDA says newly authorized COVID-19 test could double capacity for rapid at-home testing
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The FDA issued an emergency use authorization for a rapid COVID-19 test that it said could dramatically increase at-home testing capacity in the United States.
The authorization was issued for ACON Laboratories’ over-the-counter Flowflex COVID-19 antigen test for at-home use.
In a statement, Jeffrey E. Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said the authorization “should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks.”
He said ACON Laboratories plans to produce more than 100 million tests per month by the end of the year, rising to 200 million per month by February 2022.
Former FDA commissioner Scott Gottlieb, MD, said the authorization was a “major” development.
“This will allow for significant expansion in availability of rapid, easy to use at home tests for Covid. Supply ready to go,” Gottlieb tweeted. “These authorizations represent a major new policy effort by FDA to make tests for infectious disease accessible for consumer use.”
Since March 2020, the FDA has authorized more than 400 COVID-19 tests and sample kits, including rapid, OTC, at-home tests.
Last month, President Joe Biden announced a six-pronged plan to combat the rise of COVID-19 cases in the U.S. One prong consisted of making at-home COVID-19 tests more available and affordable.
“We believe at-home diagnostic tests play a critical role in the fight against COVID-19,” Shuren said. “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.”
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FDA. Coronavirus (COVID-19) Update: FDA authorizes additional OTC home test to increase access to rapid testing for consumers. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-otc-home-test-increase-access-rapid-testing. Accessed Oct. 5, 2021.
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