Roche COVID-19 at-home test granted FDA Emergency Use Authorisation

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

Roche has 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.

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 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, 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.