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.
The variant has become dominant in the United States with lightning speed, dashing hopes for a more normal holiday season, resurrecting restrictions, and stretching the country’s testing infrastructure ahead of holiday travel and gatherings.
“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 United States from January.
The test’s 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 variant of the coronavirus.
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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