The U.S. drug regulator has granted emergency use authorization to German health technology company Siemens Healthineers’ at-home COVID-19 tests, a move that will boost availability of tests pressured by rising infection cases.
The approval comes at a time when companies such as Walmart Inc., Walgreens Boots Alliance, and CVS Health Corp. have limited sales of at-home COVID-19 testing kits as demand surged owing to the swift spread of the new variants of the coronavirus in the country.
The test, which is expected to be available starting January, can be used for self-testing in people as young as 14 or adult-collected samples from individuals aged 2 to 13 years, Siemens said on Wednesday.
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 Department of Health and Human Services (HHS) said.
The U.S. government recently unveiled plans to buy 500 million rapid COVID-19 tests to be distributed for free to Americans who request them starting in January.
In October, the HHS said the U.S. government would invest $70 million to help bring at-home tests into U.S. market in coordination with the U.S. Food and Drug Administration.
Last week, Roche said the FDA had granted EUA to its COVID-19 at-home rapid test that can be used by people as young as 14.