Late last week, Roche announced that the U.S. FDA granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test, as infections surge around the country and Americans scramble to find testing.
The test uses an anterior nasal swab sample that can be self-collected and self-tested by individuals. The Swiss biopharma says the test is able to produce accurate and reliable 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 NIH Rapid Acceleration of Diagnostics’ Independent Test Assessment Program, which aims to accelerate the regulatory review and availability of OTC tests to the American public.
Roche says that starting in January, the tests will be available across the U.S. and in accordance with local guidelines and testing strategies. The launch will be in partnership with South Korea's SD Biosensor, with whom Roche has a global distribution agreement. Roche says it has the capacity to produce tens of millions of tests per month to help support the pandemic response.