Roche's at home covid test kit gets emergency FDA approval

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.

A box of material for rapid COVID-19 antigenic tests made by Swiss drugmaker Roche is pictured at the University Hospital (CHUV) during the coronavirus disease (COVID-19) outbreak in Lausanne, Switzerland, November 13, 2020. (photo credit: REUTERS/DENIS BALIBOUSE/FILE PHOTO)
A box of material for rapid COVID-19 antigenic tests made by Swiss drugmaker Roche is pictured at the University Hospital (CHUV) during the coronavirus disease (COVID-19) outbreak in Lausanne, Switzerland, November 13, 2020.
(photo credit: REUTERS/DENIS BALIBOUSE/FILE PHOTO)

Roche said on Friday that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to its COVID-19 at home covid test kit 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 US 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.

 People queue to be tested for COVID-19 in Times Square, as the Omicron coronavirus variant continues to spread in Manhattan, New York City, US, December 20, 2021. (credit: REUTERS/ANDREW KELLY TPX IMAGES OF THE DAY) People queue to be tested for COVID-19 in Times Square, as the Omicron coronavirus variant continues to spread in Manhattan, New York City, US, December 20, 2021. (credit: REUTERS/ANDREW KELLY TPX IMAGES OF THE DAY)

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."