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US FDA Approves Its At-Home Covid-19 Rapid Test Kit, Says Roche


25/12/2021


US FDA Approves Its At-Home Covid-19 Rapid Test Kit, Says Roche
People in the United States as young as 14 years will now be able to use the Covid-19 at-home rapid test kit that has been made by Roche as the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to this test, the company said on Friday.
 
Using an anterior nasal swab sample, the test is "able to produce accurate, reliable and quick results in as few as 20 minutes" for testing SARS-CoV-2 and all of the variants of concern including the highly transmissible Omicron variant, the drugmaker said in a statement.
 
The pace at which the Omicron variant of the coronavirus has become the dominant strain in the United States has been very quick and has dampened hopes of millions of enjoying a normal holiday season. Some of the restrictions imposed during the previous waves of the pandemic have been re-imposed. The sudden and massive increase in infections has also put pressure on the Covid-19 testing infrastructure of the country prior to the holiday travel and gatherings period.
 
"Roche has the capacity to produce tens of millions of tests per month to help support the pandemic response," the Swiss firm said. The company will make the tests available throughout the country starting January 2022.
 
The approval of the testing kit from Roche coincides with a limiting of sales of at-home Covid-19 testing kits by companies such as Walmart Inc, Walgreens Boots Alliance, and CVS Health Corp because of a massive and sudden increase in demand for the test kits in the face of the fast spread of the Omicron variant.
 
In a recent announcement, US president Joe Biden unveiled the government’s plans of buying more than 500 million rapid Covid-19 test kits which are to be distributed among Americans for free and to those who request the kits starting in January next year.
 
According to ot Roche, its test can also be used for children between the age of 2 and 13 years but under the supervision of adults.
 
"The launch will be in partnership with SD Biosensor Inc, with whom Roche has a global distribution agreement," the company said.
 
(Source:www.reuters.com)