Abbott announced today it has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription. Abbott will begin shipping to major food, drug and mass merchandiser retailers in the coming weeks and expect the test to be available through some of their online store websites.
The test can be used on children as young as two years old when samples are collected by an adult and for all people aged 15 years or older, bringing the country’s most extensively studied and widely used rapid antigen test to nearly everyone in the U.S. The test will come in a two-count box to meet serial (frequent) testing requirements.
Using the test will be simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deep nasopharyngeal swab) and all materials required to perform the test (swab, test card, and reagent solution) will come in the box.
“We’ve now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances,” said Robert B. Ford, president and chief executive officer, Abbott. “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.”
Abbott launched the BinaxNOW professional test nationwide in August 2020 and scaled up production at its new U.S. manufacturing facilities to produce 50 million tests per month. The U.S. Department of Health and Human Services (HHS) purchased the company’s first 150 million tests, sending them to K-12 schools, nursing homes, historically black colleges and universities and underserved communities, where they remain in use today and serve as a powerful tool to help prevent the virus from spreading. Since its approval, BinaxNOW has also been used by workplaces, K-12 schools and universities and other organizations throughout the country.
The BinaxNOW Self Test is the same technology as the existing BinaxNOW test that has been available since August 2020 but is indicated by the FDA for serial asymptomatic testing, meaning that people should test themselves frequently.