FDA authorizes 2 COVID at-home tests

By LabPulse.com staff writers

January 3, 2022 -- The U.S. Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two additional COVID-19 at-home tests: the Siemens' CliniTest Rapid COVID-19 Antigen Self-Test and the SD Biosensor test distributed by Roche.

Both tests received the EUAs after being evaluated through the Biden administration's new accelerated pathway to support the FDA's review of tests. The program also provides an opportunity for large-scale manufacturing that the U.S. Department of Health and Human Services announced earlier in 2021.

The timely authorizations are due to a collaboration between the FDA and the National Institutes of Health Rapid Acceleration of Diagnostics Technology (RADx) program. Combined, it is estimated the companies can produce tens of millions of tests per month for use in the U.S., according to a press release by the FDA.

Biden outlines strategy for COVID testing to get ahead of omicron
Not even a week after the U.S. declared omicron a variant of concern, President Joe Biden on December 2 laid out the administration's winter plan for...
FDA tightens policy on reviews of lab-developed tests
The U.S. Food and Drug Administration (FDA) is withdrawing a policy begun during the COVID-19 pandemic that allowed laboratory-developed tests (LDTs)...

Copyright © 2022 LabPulse.com

Last Updated ls 12/30/2021 9:35:11 AM

Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current