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.
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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.
(Reporting by Dania Nadeem in Bengaluru; Editing
by Shinjini Gan
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