The new indication for the diagnostic allows individuals with or without symptoms to access the BinaxNOW COVID-19 Ag self-test over the counter, without a prescription. The company plans to begin shipping to major food, drug and mass merchandiser retailers in the coming weeks. It also anticipates availability through some online stores, according to a news release.
Abbott Park, Ill.-based Abbott said it expects the BinaxNOW self test to be priced affordably – similar to common OTC tests, of which a couple of others were authorized by the FDA, today, too.
The Quidel Quick-View at-home test and the BD Veritor Plus system, which was authorized for POC screening with a prescription, joining Abbott’s BinaxNOW test as authorized OTC COVID-19 diagnostics. The FDA said the addition of the OTC and POC tests for screening will offer schools, workplaces, communities and others several options for serial screening tests that are both accurate and reliable.
The BinaxNOW test can be used on children as young as 2 when samples are collected by an adult plus all people aged 15 years or older. The rapid antigen test will come in a two-count box.
Those using the test will only need to perform a minimally invasive nasal swab, rather than a deep nasopharyngeal swab, with all materials required to perform the test to be provided in the two-count box.
BinaxNow was initially authorized and launched in August, while Abbott has since scaled up production at new U.S. manufacturing facilities to produce 50 million tests per month. Almost straight away, the U.S. government purchased 150 million tests for $750 million. Workplaces, schools and other organizations across the U.S. have been using the tests since.
“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,” Abbott president & CEO Robert B. Ford said in the release. “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.”