At-home COVID-19 rapid test gets ok from USFDA: Roche

The test, which uses an anterior nasal swab sample, is "able to produce accurate, reliable and quick results in as few as 20 minutes

198
Lab Laboratory Rapid test
Picture: Pixabay

Last Updated on January 15, 2022 by The Health Master

Roche said on Friday that the U.S. Food and Drug Administration (USFDA) 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 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 U.S. 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.

U.S. 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.

According to the company, the test can also be used for children aged 2-13 years under adult supervision.

“The launch will be in partnership with SD Biosensor Inc, with whom Roche has a global distribution agreement.” (Reporting by Vishal Vivek in Bengaluru; Editing by Sandra Maler)

Remdesivir drug should only be used in patients with ‘moderate to…

Schedule for 19 FDCs permitted pre-1988 to give online presentation

DCGI seeks more data from Serum Institute for Covovax Vaccine

Clinical Study for Itolizumab initiated in India

Doctor couple booked for using restricted drug at hospital

IPC adds 15 new impurities Reference Substances and 11 IP Reference…

Drug alert: 22 out of 1102 samples declared as NSQ in…

Govt is able to collect data on only 237 Medical devices

Govt is working on policy to encourage research in Pharma sector

Haryana is the best state for setting up Pharma Industries: HM

Latest Notifications regarding Pharmaceuticals

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news