BinaxNOW COVID-19 home test granted emergency use authorization by FDA

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Abbott this week for its BinaxNOW COVID-19 Ag Card Home Test, allowing for virtually guided use by anyone 15 years or older, with a prescription.

Healthcare providers will refer such patients to the antigen test if they suspect them of having COVID-19 within the first seven days of symptom onset. The test, offered in partnership with a telehealth service, will be provided for $5. It utilizes a self-collected nasal swab sample. Further, adults will use those nasal swabs to collect samples from individuals ages four years or older.

A previous EUA had authorized the BinaxNOW test only for use by medical personnel or trained operators in certain non-clinical environments operating under CLIA certificate.

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” Dr. Stephen Hahn, FDA Commissioner, said. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”

Through the telehealth service, guides will walk users through the process step-by-step, including reading and understanding the results. All test results will then be reported to public health authorities.

“With today’s authorization of the BinaxNOW COVID-19 Ag Card Home Test, there are now three tests that can be used completely at home,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said. “We will continue to work with test developers to support the availability of more innovative testing options.”

The U.S. Department of Health and Human Services (HHS) has been in the process of distributing 150 million federal purchased ag card tests to states and other recipients. Abbott now produces tens of millions of tests per month.