FDA authorizes Siemens Healthineers' at-home COVID test
The Biden administration announced Wednesday that the FDA issued an emergency use authorization for an at-home COVID-19 test distributed by German company Siemens Healthineers.
Why it matters: Companies including Walmart, Walgreens Boots Alliance and CVS Health have this month put limits on the number of at-home COVID-19 testing kits customers can buy as the Omicron and Delta variant surge across the U.S., per Reuters.
- President Biden said Monday his administration has "more work to do" in scaling up rapid testing efforts amid shortages across the U.S.
The big picture: Siemens Healthineers' Clinitest rapid COVID-19 antigen self-test is authorized for use by anyone over 14 years of age or adult-collected samples from those age 2 to 13 years, per a company statement. It's expected to be available beginning in January.
- The approval comes less than a week after Roche announced the Food and Drug Administration had authorized its COVID-19 at-home rapid test for those over 14.
- The Department of Health and Human Services confirmed the approval of the Siemens Healthineers and Roche's tests in a statement Wednesday.
What's next: The Biden administration plans to purchase 500 million rapid tests to deliver to homes for free starting in January.