Abbott's $25 Rapid Coronavirus Test Authorized For At-Home Use

GREEN OAKS, IL — Illinois-based Abbott Laboratories' rapid coronavirus test received emergency use authorization Wednesday from the U.S. Food and Drug Administration for use at home with a prescription.

At $25, Abbott's BinaxNOW test becomes the third and most affordable rapid test yet to receive FDA clearance for at-home use. The test delivers results from a self-collected nasal swab within about 20 minutes.

Abbott's home test is only authorized to be used under the supervision of a telehealth proctor, according to a release announcing its authorization. The company partnered with the digital health care company eMed. The Miami-based company handles the eligibility process and guides users through the collection process.

eMed Chief Executive Officer Dr. Patrice Harris said she was proud of efforts to democratize access to frequent, affordable rapid at-home testing.

"COVID-19 is the greatest public health threat our nation has experienced in a century," Harris said. "This pandemic has had devastating effects in every region of our country but particularly on seniors, essential workers and communities of color. FDA's authorization of Abbott's BinaxNOW test for home use is a breakthrough in the battle against COVID-19."

Robert Ford, Abbott's president and chief executive officer, said the partnership maintains the integrity of the testing process and reaches people who need testing.

"As the pandemic has evolved, the need for rapid testing has only grown," Ford said. "Unfortunately, we're still hearing that many people can't access testing as quickly as they need it."

In August, Abbott's rapid card-based test was authorized for use in professional settings, where studies have suggested it is more than 90 percent accurate at detecting the virus that causes COVID-19 in people with enough of it in their bodies to be contagious.

Since then, the company has increased production to pump out 50 million tests a month at U.S. facilities, which are being distributed through the federal government.

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On Nov. 17, the FDA authorized the use of the first entirely at-home testing system, the Lucira COVID-19 All-In-One Test Kit. It also required a prescription.

Then on Tuesday, the FDA cleared a home antigen test from the Austrian manufacturer Ellume, the first non-prescription rapid test for home use.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab," Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said announcing the authorization of the Ellume test. "However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

The Ellume test will be priced around $30 and be available for purchase at pharmacies and online without a prescription. It was authorized for use among asymptomatic people, while Abbott's BinaxNOW tests are only cleared for use among people with symptoms.

Abbott representatives said the company plans to produce and distribute 30 million BinaxNOW tests in the first quarter of 2021 and 90 million more in the second quarter.

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” FDA Commissioner Dr. Stephen Hahn said Wednesday in announcing Abbott's latest emergency use authorization. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”