Abbott’s BinaxNOW COVID-19 rapid test receives FDA emergency use authorization

December 17, 2020 – Abbott (Abbott Park, IL) announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for virtually guided at-home use of its BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection.

Abbott is bringing BinaxNOW, a rapid test, into the home where the result is delivered in minutes without the need to send it out for processing. The $25 cost for the test and service is the lowest currently available for at-home testing, Abbott says.

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

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

Since launching BinaxNOW in August, Abbott has ramped up capacity to 50 million tests a month in its U.S. facilities that are currently being distributed through the federal government and is expanding further so even more people have access to the tests.

The eMed service offering costs $25 a test, and eMed takes care of determining eligibility, the guided self-collection process, public health reporting requirements and gets people their results through their NAVICA app in a matter of minutes.

Through eMed and the NAVICA app, people can use authenticated BinaxNOW results to enter into venues that accept the NAVICA digital certificate. The virtually guided process preserves the integrity of the testing process and state-mandated reporting obligations, while ensuring equitable access to people who need tests through the prescription process.

Learn More