FDA Issues EUA for First At-Home COVID-19 Diagnostic Test

This non-prescription test allows users to perform and get results themselves without a medical provider or laboratory needed.

The US Food and Drug Administration (FDA) announced today it had issued an emergency use authorization (EUA) for the Ellume COVID-19 Home Test. This authorization is for the first over-the-counter fully at-home COVID-19 diagnostic test.

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” FDA Commissioner Stephen M. Hahn, MD, said.

This test does not need a prescription and comes after the FDA authorized the first prescription COVID-19 test for home use in November and the first non-prescription test system, in which a lab processes the self-collected sample, last week.

Since the beginning of the pandemic, the agency has authorized more than 225 COVID-19 diagnostic tests, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Hahn said.