FDA grants new EUA for at-home use of Abbott BinaxNOW

Dec. 17, 2020

The U.S. Food and Drug Administration (FDA) issued a new emergency use authorization (EUA) to Abbott for a virtually guided at-home use of the company's BinaxNOW COVID-19 Ag Card Home Test, according to press releases.

Abbott said the cost for the test and the service, which requires a prescription, is $25.

The FDA said it considers the product for consumers to be different than the BinaxNOW COVID-19 Ag Card professional use product, which received an EUA from the FDA in August.

To facilitate the delivery of the BinaxNOW test to the home and the guided collection and testing process, Abbott said it has partnered with digital health solutions provider eMed.

Abbott and eMed expect to deliver and administer 30 million BinaxNOW at-home tests, an antigen test, in the first quarter of 2021, with an additional 90 million in the second quarter.

This is how it works:

Patients access the eMed service through Abbott's NAVICA app, which can be downloaded from the Apple and Android app stores. Once eligibility requirements are met, the test kit is shipped directly to the home or a pick-up location, allowing patients to remain isolated until their status is known.

Once a BinaxNOW test kit arrives at their home, users log into the eMed portal for their guided testing session and can expect results in approximately 20 minutes. The eMed certified guides are available to answer questions throughout the testing process.

Using NAVICA, people also will be able to display their results when entering facilities requiring proof of testing.

Since launching the BinaxNOW professional product in August, Abbott said it has ramped up capacity to 50 million tests a month in its U.S. facilities and is expanding production further. The federal government is distributing the professional product.

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