Roche COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States

Rapid test to support the American public ’s fight against the COVID-19 pandemic, with availability to purchase over-the-counter (OTC) at pharmacies and retailers nationwideThe COVID-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.EUA granted through Roche ’s participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program to bring rapid tests to the OTC marketBasel, 24 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. ¹ 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-C oV-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 Americ...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news