The FDA has issued an emergency use authorization (EUA) for the Acon Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test.
According to the company, the Flowflex COVID-19 Antigen Home Test is a simple nasal swab test which will soon be available for purchase without a prescription in major retail stores and online. It may be used for self-testing by individuals aged 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.
“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,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health.
Today’s 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 US over the next several weeks. By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.
Since March 2020, the FDA has authorized more than 400 COVID-19 tests and sample collection devices, including authorizations for rapid, OTC at-home tests. The FDA considers at-home COVID-19 diagnostic tests to be a high priority and we have continued to prioritize their review given their public health importance.
Most antigen tests for at-home use are authorized for serial testing, or testing the same individual more than once within a few days. These authorizations followed the announcement of a streamlined approach to help facilitate the authorization of rapid tests for use with serial testing programs, which has increased consumer access to testing. “Notably, based on the data provided for asymptomatic individuals, the Acon Laboratories Flowflex COVID-19 Home Test does not require serial testing. Today’s authorization will facilitate even greater access and testing capacity,” the FDA added.