FDA Gives Green Light to Abbott’s Rapid $25 Covid Test for At Home Use

As the nation anticipates the FDA giving emergency clearance this week to Moderna’s coronavirus vaccine, the administration has already had an exciting authorization done this week.

The FDA on Wednesday authorized Abbott Labs’ rapid Covid-19 test for at-home use.
This is the third test authorized in the U.S. “that can be used completely at home,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. Doctors must prescribe the test for patients first however.

Patients collect the sample with a nasal swab themselves and an app helps guide the testing process and provide results, Abbott said.

The antigen test delivers results in about 15 minutes and had previously been authorized for use by trained personnel only, but the new clearance will allow patients to test themselves at home with virtual assistance from a doctor.

Dubbed BinaxNOW, the test costs $25 for at-home use and to deliver to people’s homes and to supervise the collection and testing process. Abbott said it has partnered with telehealth provider eMed.

Everyone 15 years or older who are suspected of having Covid-19 by their health-care provider and is within the first seven days of symptom onset are eligible for the test, the FDA said. The agency added that the test can also be used in people 4 years or older, though an adult needs to collect the sample.

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” FDA Commissioner Dr. Stephen Hahn stated. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”

Abbott said it expects to deliver 30 million at-home tests in the first quarter of 2021, with another 90 million in the second quarter.

“As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we’re still hearing that many people can’t access testing as quickly as they need it,” Robert Ford, Abbott’s president and CEO, commented. “That’s why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes.”

“FDA’s authorization of the BinaxNOW card test for home use means we should have tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their home,” Health and Human Services Secretary Alex Azar said Wednesday in a statement.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.