FDA authorizes Ellume test as first over-the-counter, at-home COVID-19 diagnostic

The U.S. Food and Drug Administration (FDA) has issued the first-ever emergency use authorization (EUA) for an over-the-counter, at-home test for COVID-19, awarding that honor to the rapid Ellume COVID-19 Home Test.

This means anyone at least two years of age or older, whether displaying symptoms of COVID-19 or not, will be able to get the Ellume test without a prescription. An antigen test, it runs a liquid sample — acquired by nasal swab — along a surface with reactive molecules to detect fragments of SARS-CoV-2 proteins. Using an analyzer, it then connects with a smartphone-based software application to perform the test and help patients interpret the results, which can have a turnaround time of as little as 20 minutes.

“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,” Dr. Stephen Hahn, FDA Commissioner, said. “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.”

In testing, the Ellume diagnostic correctly identified 96 percent of positive samples and all negative samples in patients displaying symptoms of COVID-19. Results dropped slightly in those without symptoms, to 91 percent for positive samples and 96 percent for negative samples, but the overwhelmingly successful results still earned the FDA’s approval.

Ellume expects to make more than 3 million of the take-home tests in January 2021.