FDA authorizes Siemens Healthineers’ at-home COVID test

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The rapid COVID-19 antigen self-test is authorized for use by anyone over 14 years of age

The Biden administration has announced that the FDA issued an emergency use authorization for at-home COVID-19 test manufactured by German company Siemens Healthineers. The approval comes at a time as the Omicron and Delta variant surge across the U.S.

This move will boost availability of tests Walmart, Walgreens Boots Alliance and CVS Health have put limits on the number of at-home COVID-19 testing kits customers can buy as demand surged due spread of the new variants of the coronavirus.

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, according to a company statement. It’s expected to be available from January.

“Rapid antigen testing provides results in just 15 minutes and the information can help reduce the risk of COVID-19 exposure” the company said.

The authorization was granted under Biden administration’s accelerated review program that aims to bring tens of millions of new tests per month to the country.

The U.S. government recently unveiled plans to distribute 500 million rapid COVID-19 tests to be distributed for free to Americans who request them starting in January.