The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for an over-the counter (OTC) COVID-19 test from Siemens Healthineers.
The test from Siemens, as well as an OTC COVID-19 test from Roche, received EUAs through an accelerated pathway for tests with potential for large-scale manufacturing. “Combined, it is estimated the companies can produce tens of millions of tests per month for use in the U.S.” the Department of Health and Human Services said.
The FDA authorized the CLINITEST Rapid COVID-19 Antigen Self-Test from Siemens Healthineers for unsupervised self-testing in people 14 years of age and older, as well as for adult-collected samples from people 2-13 years of age.
Siemens Healthineers said the product has a sensitivity of 86.5% (95% CI: 79.6 to 91.3%) and a specificity of 99.3% (95% CI: 95.9 to 100.0%) compared to the nucleic acid (PCR) detection method.
In the new evaluation pathway, HHS said the National Institute of Health’s (NIH) RADx Tech “network of experts from government, academia, and industry work together with FDA, CDC and other HHS specialists to assess and conduct studies on over-the-counter tests. The coordinated effort allows companies to compile proper data, work towards the right benchmarks for performance, and support other needs that will help ensure they are providing the best submissions possible for FDA's regulatory review.”
Roche said its test, the COVID-19 At-Home Test, will be available across the U.S, starting in January 2022.
The Roche test is a result of a 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.