Roche today 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.² 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 prioritized 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.
Together with the COVID-19 At-Home Test, Roche will offer NAVIFY® Pass as a solution to organizations who want to allow individuals and health care 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 Inc., 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, including the SARS-CoV-2 Rapid Antigen Tests (Nasopharyngeal/Nasal), SARS-CoV-2 Antigen Self Test Nasal, SARS-CoV-2 Rapid Antibody Test and SARS-CoV-2 & Flu A/B Rapid Antigen Test.3 The test becomes the first rapid antigen test for SARS-CoV-2 from Roche to receive FDA Emergency Use Authorization, and the sixth rapid test overall to accompany Roche’s comprehensive portfolio of diagnostic solutions to help healthcare systems across the globe combat the COVID-19 pandemic through laboratory testing and at the point of care. Roche Diagnostics’ portfolio includes a wide range of molecular, rapid serological, and digital solutions that help diagnose and manage COVID-19 during the initial stages of infections, during the recovery phase, and following the resolution of infection.