The FDA made the announcement in a release Thursday, stating the approvals were given to “get more tests for screening asymptomatic individuals on the market.”
The federal agency approved BinaxNOW COVID-19 Antigen Self Test by Abbott Laboratories, a U.S. medical device company, and QuickVue At-Home OTC COVID-19 test by Quidel Corporation, a U.S. diagnostics healthcare products manufacturer.
It also approved a third test, BD Veritor System’s Rapid Detection of SARS-CoV-2, for use in point-of-care settings.
“Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country’s pandemic response — many schools, workplaces, communities and other entities are setting up testing programs to quickly screen for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “As the pandemic has progressed, we have worked with test developers wishing to add screening claims.”
The FDA said the products had previously been authorized to test patients exhibiting COVID-19 symptoms but Thursday’s authorization approves their use for asymptomatic cases when patients do not exhibit indicators they may have contracted the virus.
Abbott said its test, which involves a minimally invasive nasal swab, can be used on children as young as two years old.
“Together with vaccines, the BinaxNOW Self Test will help Americans get back to doing what they want and need to do — like going to work and school or seeing friends and family — with greater confidence,” Robert Ford, president and chief executive officer at Abbott, said in a statement.
The company said it can produce 50 million tests a month with the U.S. Department of Health and Human Services having purchased its first 150 million tests to send to K-12 schools, nursing homes, historically Black colleges and universities and underserved communities.
Quidel said in a statement that it aims to make its COVID-19 tests as widely available as possible.
“FDA’s authorization opens the door to true democratization of the benefits of serial testing for both individuals experiencing symptoms and screening of people who may not have symptoms but are actively shedding the virus,” said Quidel Corp. CEO Douglas Bryant.