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 fast, 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. In addition, based on data provided for asymptomatic individuals, FDA said 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-negative and false-positive results, meaning individuals should self-isolate and seek additional care from healthcare providers following a positive test. In contrast, those who test negative and experience COVID-19 like systems should follow up with providers because negative results don’t rule out COVID-19 infection.
“We believe at-home diagnostic tests play a critical role in the fight against COVID-19,” Shuren wrote. “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.”