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

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Roche says at-home COVID-19 rapid test gets ok from FDA
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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 a 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 U.S. from January.

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