Ellume's COVID-19 test nabs first at-home, over-the-counter emergency use authorization

FDA commissioner Stephen Hahn
FDA Commissioner Stephen Hahn, M.D. (FDA)

Ellume has been given an emergency use authorization for its over-the-counter pandemic test you can take at home.

This comes after the FDA’s speedy authorization for the first all-in-one home prescription COVID-19 test from Lucira, with results in 30 minutes for home use, and after also granting the first nonprescription test system last week, in which a lab processes the self-collected sample.

Ellume, which recently tied up a deal with Qiagen for a portable antigen test, goes a step further with its new diagnostic by not requiring a prescription or a lab. A user can go to a local drugstore, “buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” according to FDA Commissioner Stephen Hahn, M.D.

The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. According to Ellume, its test has a sensitivity of 96% and specificity of 100%, and, in asymptomatic individuals, it hit a sensitivity of 91% and specificity of 96%.

The Ellume COVID-19 Home Test uses an analyzer that connects with an app on a smartphone to help users perform the test and interpret results. Ellume is slated to produce around 3 million of these by next month and 20 million by the second half of 2021.

This adds to the FDA’s growing list of speedy COVID-19 tests that are geared up to lower the pressure on labs across the country but maintain high levels of testing.

RELATED: FDA greenlights first all-in-one home COVID-19 test, with results in 30 minutes

“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them. Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”