Roche COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing in US


INDIANAPOLIS — Roche announced today that the FDA has granted the company emergency use authorization for its at-home rapid COVID-19 test due to the national shortage of COVID rapid tests.

The test is a simple nasal swab test and can be self-collected and tested by those 14 and older and with an adult for those ages 2-13.

Roche’s at-home test results are available in as few as 20 minutes and test for SARS-CoV-2 and all known variants of concern, including Omicron.

“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,” said Thomas Schinecker, CEO, Roche Diagnostics.

“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 Roche at-home test will be available beginning in January 2022 and will be available all across the U.S.

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