Dec 29, 2021 - Health

FDA authorizes Siemens Healthineers' at-home COVID test

Rebecca Falconer

A stack of Covid-19 rapid tests "Clinitest Rapid COVID-19 Antigen Test" from Siemens Healthineers lie in the classroom at Lessing-Gymnasium in Wedding-Berlin. — A stack of COVID-19 rapid tests from Siemens Healthineers. Photo: Fabian Sommer/picture alliance via Getty Images

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.

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FDA authorizes Siemens Healthineers' at-home COVID test

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