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U.S. authorizes German firm Siemens Healthineers' at-home COVID-19 test

reuters.com · 12/29/2021 18:12
U.S. authorizes German firm Siemens Healthineers' at-home COVID-19 test

- The U.S. drug regulator has granted emergency use authorization to German health technology company Siemens Healthineers' SEMHF 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 WMT, Walgreens Boots Alliance WBA and CVS Health Corp CVS 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. nL4N2T60E4

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 ROG.S said the FDA had granted EUA to its COVID-19 at-home rapid test that can be used by people as young as 14. nL1N2T90QM

(Reporting by Dania Nadeem in Bengaluru; Editing by Shinjini Ganguli)