HHS Secretary Azar Statement on FDA Authorization of First Fully At-Home, Over-the-Counter COVID-19 Test

On Tuesday, the Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19 that does not require a prescription, the Ellume COVID-19 Home Test, which was developed with $30 million in support from the NIH’s RADx Tech program. HHS Secretary Alex Azar issued the following statement:

“FDA has authorized the first COVID-19 test that you can purchase over-the-counter, take at home, and get a rapid result, representing a major breakthrough for Americans’ ever-expanding access to convenient COVID-19 testing options. HHS provided support for this new option through NIH’s RADx initiative, the diagnostics component of Operation Warp Speed, which supports not only development work but also efforts to scale up production to deliver the broadest possible access to new testing options. With new at-home options emerging and tens of millions of rapid tests already strategically distributed by HHS this fall to states, we have brought together the best of the public and private sectors to build the world’s greatest testing system.”

Read the FDA press release here: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic

Read the NIH press release here: https://www.nih.gov/news-events/news-releases/nih-funded-covid-19-home-test-first-receive-over-counter-authorization-fda