In an announcement made on Friday, Roche announced that the FDA had approved an emergency use authorization for their Covid-19 at-home rapid test that can be used by people as young as 14.
In a statement, the drugmaker said the test can produce accurate, reliable and quick results for SARS-CoV-2 and all variants of concern, including Omicron, based on a nasal swab.
As the Omicron variant has become dominating across the nation with lightning speed, shattered hopes for a more normal holiday season, resurrecting restrictions and stretching the country’s testing infrastructure before the holidays.
Roche can produce tens of millions of tests per month to support the pandemic response, the Swiss firm said, adding that the tests will be available throughout the US starting in January.
At a time when companies including Walmart Inc, Walgreens Boots Alliance, and CVS Health Corp have limited sales of at-home Covid-19 testing kits due to the swift spread of the viral variant, the test’s approval comes at the right time.