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Abbott Labs’ 15-Minute Virus Test Gets Emergency Authorization

Aug. 28, 2020
The test will be paired with an app designed to display a health pass for negative test results.

Abbott Laboratories announced August 26 that its rapid COVID-19 test has received an emergency use authorization from the Food and Drug Administration.

According to a statement from the Illinois-based medical equipment manufacturer, the BinaxNOW test delivers results within 15 minutes by testing a nasal swab (a shorter swab than the nasopharyngeal swab used in other tests) for SARS-COV-2 antibodies. Each test will cost $5.  

The EUA opens the door for the test to be used by medical professionals who already have Abbott’s ID Now testing platform, commonly used to test for strep throat or influenza. In March, Abbott Laboratories said that about 18,000 of the testing platforms are currently in circulation in doctors’ offices around the country.

In addition, both the test and the testing platform it runs on are highly portable: Abbott Laboratories says the test itself is about the size of a credit card, and the ID Now platform it runs on is about the size of a toaster.

Alongside the test EUA, Abbott Labs announced a novel healthcare offering: a free phone application called Navica that displays a health pass for anyone who tests negative for COVID-19 using the BinaxNOW app. The pass, which is temporary, lists the date of the negative test and renews itself each time the person is tested.

“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,” said Robert Ford, CEO of Abbott.

Joseph Petrosino, Ph.D., Chairman of Molecular Virology and Microbiology at the Baylor College of Medicine, said that the test would give “tens of millions of people” access to “rapid and reliable testing.” “With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus,” he said.

Dr. Charles Chiu, Ph.D., professor of Laboratory Medicine at the University of California, San Francisco, said the test would relieve the COVID-19 testing burden currently weighing on laboratories around the country.

The Advanced Medical Technology Association currently estimates that test manufacturers are shipping about a million tests per day. Abbott Laboratories plans to ship tens of millions of the rapid tests in September and ramping production to 50 million tests a month by the beginning of October. 

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