Roche announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Covid-19 At-Home Test. The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old. The test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.

The FDA’s EUA decision stems from Roche’s participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics’ (RADx) Independent Test Assessment Program (ITAP), which aims to accelerate the regulatory review and availability of high-quality, accurate and reliable OTC tests to the American public. The Covid-19 At-Home Test was prioritised by the FDA based on Roche and SD Biosensor’s ability to deliver large quantities of high-quality tests and ramp up manufacturing to meet future demands.

Starting in January, the Covid-19 At-Home Test will be available across the United States and in accordance with local guidelines and testing strategies. At the time of launch, Roche has the capacity to produce tens of millions of tests per month to help support the pandemic response. The Covid-19 At-Home Test offers a convenient frequent testing option without the need to visit a healthcare provider.

“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.”