SAN DIEGO — In a bid to increase consumer access to rapid testing, the U.S. Food and Drug Administration on Monday issued an emergency use authorization for a new over-the-counter COVID-19 antigen test.
According to the agency, authorization for the ACON Laboratories Flowflex COVID-19 Home Test “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.”
Meanwhile, San Diego-based ACON plans to produce more than 100 million tests per month by year’s end, a figure expected to double to 200 million monthly tests by February 2022, the FDA confirmed.
“This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers,” the agency added.
The FDA has authorized more than 400 COVID-19 tests and sample-collection devices since March 2020, including authorizations for rapid, OTC at-home tests, which it has prioritized “given their public health importance,” the agency stated.
“We believe at-home diagnostic tests play a critical role in the fight against COVID-19,” the FDA stated, reminding patients that “all tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not rule out a COVID-19 infection.”
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