FDA authorizes rapid Roche COVID-19 test for emergency over-the-counter use

The United States Food and Drug Administration (FDA) bestowed emergency use authorization (EUA) to Roche’s COVID-19 at-home test last week, expanding over-the-counter options for those concerned about SARS-CoV-2 and its variants.

As a result, the test will now be available for self-use by those at least 14 years old, or by adult-assisted use on those as young as 2 years old.

“The COVID-19 pandemic continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect their personal health and the health of their families and communities,” Thomas Schinecker, CEO of Roche Diagnostics, said. “At this inflection point in the American public’s fight against COVID-19, we are proud to have worked in close collaboration with the US Government to introduce and expand access to accurate, reliable, and high-quality at-home tests.”

The test is quick, able to produce results in as little as 20 minutes after sample collection by a simple nasal swab. It’s capable of noting all known variants of concern, including the wide-spreading omicron variant.

The test will become available as of January 2022, through pharmacies and retailers in accordance with local guidelines and testing strategies. Its authorization was fast-tracked, though, due to the history of Roche and SD Biosensor – with which Roche has locked in a global distribution agreement – with mass test production. In fact, come January, Roche predicts that it will have the ability to produce tens of millions of these tests per month to support pandemic response. The company had participated in the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program (ITAP) to further speed things along.

Roche intends to pair the COVID-19 At-Home Test with a program known as NAVIFY Pass. NAVIFY will allow organizations to remotely store, display and share results from individuals and health care professionals. By linking with the at-home tests, test results will be automatically acquired.