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Roche says at-home COVID-19 rapid test gets okayed from FDA

The test, which uses an anterior nasal swab sample, is "able to produce accurate, reliable and quick results in as few as 20 minutes" for SARS-CoV-2 and all variants of concern, including Omicron, the drugmaker said in a statement.

December 25, 2021 / 09:55 AM IST
(AP Photo/Mahesh Kumar A.)

(AP Photo/Mahesh Kumar A.)


Roche said on Friday that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to its COVID-19 at-home rapid test that can be used by people as young as 14.


The test, which uses an anterior nasal swab sample, is "able to produce accurate, reliable and quick results in as few as 20 minutes" for SARS-CoV-2 and all variants of concern, including Omicron, the drugmaker said in a statement.











"Roche has the capacity to produce tens of millions of tests per month to help support the pandemic response," the Swiss firm said, adding that the test will be available across the U.S. from January.











U.S. President Joe Biden recently unveiled plans to buy 500 million rapid COVID-19 tests to be distributed for free to Americans who request them starting in January.

The test can also be used by for children aged 2-13 years under adult supervision, according to the company. "The launch will be in partnership with SD Biosensor Inc, with whom Roche has a global distribution agreement."

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Reuters
first published: Dec 25, 2021 09:55 am
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