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The U.S. Food and Drug Administration (FDA) announced Monday that it had issued an emergency use authorization for the ACON Laboratories Flowflex COVID-19 Home Test.
The over-the-counter (OTC) COVID-19 antigen test will be added to the growing list of tests that can be used at home without a prescription.
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The agency said that the authorization is expected to double rapid at-home testing capacity over the next several weeks and that by the end of the year, ACON expects to produce more than 100 million tests per month and potentially 200 million tests per month by February 2022.
“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,” Jeffrey E. Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.
Since March 2020, the FDA has reportedly authorized more than 400 COVID-19 tests and sample collection devices.
Most of the antigen tests for at-home use are authorized for serial testing or testing the same person more than once within a few days.
Based on data for asymptomatic individuals, the ACON Laboratories Flowflex COVID-19 Home Test does not require serial testing.
These authorizations, the FDA noted, come on the heels of a previous commitment to streamline the path for COVID-19 screening tools, providing a supplemental template for test developers seeking emergency use authorization of certain tests for screening with serial testing and issuing a fact sheet that outlines considerations for selecting a test for use in a screening testing program.
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In its release, the FDA reminded patients and users that all tests can experience false-negative and false–positive results.
The agency also stressed the importance of at-home diagnostic testing in the fight against the coronavirus.
“We believe at-home diagnostic tests play a critical role in the fight against COVID-19. 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,” Shuren wrote.
San Diego-based ACON Laboratories Inc. said in its own accompanying statement that the nasal swab test would soon be available for purchase in major retail stores and online and would be used by individuals 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.
“In contrast to other home tests which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms. This will allow for the distribution of more affordable single-test packaging, resulting in greater access to home testing,” ACON Laboratories said.
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President Biden highlighted rapid tests in a speech in December, pledging that the government would purchase 280 million tests and that it would use the Defense Production Act to ensure manufacturers have the raw materials they need to make tests.
The administration is spending approximately $2 billion on the initiative.
The Associated Press contributed to this report.
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