The over-the-counter (OTC) ACON Laboratories Flowflex COVID-19 Home Test has received Food and Drug Administration (FDA) emergency use authorization.
FDA officials said the approval serves as testament to the agency’s commitment to increasing the availability of accurate and reliable OTC tests to meet public health needs while increasing consumer testing access.
According to the FDA, the approval action is slated to double domestic rapid at-home testing capacity over the next several weeks — noting by the end of the year, the manufacturer seeks to produce over 100 million tests monthly. The number is expected to increase to 200 million per month by February 2022, per authorities.
“The FDA wants to remind patients that all tests can experience false negative and false positive results,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, noted via a statement. “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.”
Shuren said the FDA believes at-home diagnostic tests are pivotal in combating COVID-19 and the agency will continue to offer support and expertise as a means of aiding development of accurate and reliable tests.