Roche said on Friday that the US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (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 drug-maker 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.
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.
US 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.”
