Roche COVID-19 At-Home Test granted FDA EUA

Dec. 28, 2021

Roche said that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the company’s COVID-19 At-Home Test.

The test uses a anterior nasal swab sample that can be 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 produces results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron. 

Roche said, “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.”

Starting in January, the COVID-19 At-Home Test will be available across the United States. At the time of launch, Roche said it will have 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.

Together with the COVID-19 At-Home Test, Roche will offer NAVIFY Pass as a solution to organizations who want to allow individuals and healthcare professionals to remotely and securely store, display, and share results. All COVID-19 At-Home Tests are supplied with a unique data matrix, enabling NAVIFY Pass to automatically link individuals’ test results to their respective test devices.

The launch will be in partnership with SD Biosensor, with whom Roche has a global distribution agreement and previously launched a range of tests throughout 2020 and 2021 in countries outside of the U.S. that accept the CE Mark.

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