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Saturday, March 6th, 2021

Abbott gains emergency use authorization for 15-minute COVID-19 antigen test

© Abbott

Abbott gained emergency use authorization from the U.S. Food and Drug Administration (FDA) this week for a COVID-19 antigen test known as BinaxNOW, which proposes to test patients for $5, with a 15-minute turnaround on results.

Quick, portable, and affordable, Abbott intends for its tool to be able to detect active coronavirus infections on a massive scale and is ramping up production accordingly. Beginning in October, the company hopes to produce as many as 50 million tests per month.

“We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives,” Robert Ford, president and CEO of Abbott, said. “BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives.”

While the test itself requires no additional equipment to use, Abbott will also launch a mobile application to work with it, known as NAVICA. That app, which will be provided free, will allow users to get and provide their test results for requesting organizations, workplaces, or schools. It will work with both iPhone and Android devices. A temporary digital health pass on the app will be renewed each time a person tests negative for the virus, with the date of the test results provided.

“While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know,” Ford said. “We’re taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible.”

Under the new EUA, the BinaxNOW card will be usable by healthcare professionals, and point-of-care settings qualified to perform the test. Doctors, nurses, school nurses, medical assistants, pharmacists, and more are all authorized to use the test with minimal training and a patient prescription.