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Roche's COVID-19 at-home rapid test given emergency FDA authorization

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Posted at 6:11 PM, Dec 24, 2021
and last updated 2021-12-28 00:34:38-05

(WRTV) — The Food and Drug Administration has granted Emergency Use Authorization to Roche's at-home rapid COVID-19 test.

Roche says results are available in as little as 20 minutes for COVID-19 and all variants of concern, including omicron. It will be available in the U.S. beginning in January.

The test is a nasal swab for those ages 2 and older that is purchased over the counter.

"We're hoping that this makes a big impact not only here in Indiana, but across the United States. We know that the demand for testing is extremely high," Dr. Jamie Phillips Deeter, Medical and Scientific Partner at Roche, said.

Roche is working to have the tests available and widely distributed at the end of January 2022.

"The COVID-19 At-Home Test was prioritised by the FDA based on Roche and SD Biosensor’s ability to deliver large quantities of high-quality tests and ramp up manufacturing to meet future demands," Roche wrote in a news release. "At the time of launch, Roche has the capacity to produce tens of millions of tests per month to help support the pandemic response."

On Thursday, WRTV checked several Indianapolis drug stores who were out of at-home COVID-19 tests that are currently on the market. Many stores don't know when they'll get more.

Phillips Deeter says it's important to read the instructions that come with the test. The National Institute of Health and Roche worked together on developing the tests, which will be manufacutred in South Korea and shipped over.

The company's North American headquarters are located in Indianapolis at 9115 Hague Road. Roche is the world's largest biotech company and develop diagnostic products.

This week, the White House announced several measures to battle the impending omicron wave, including purchasing 500 million at-home rapid COVID-19 tests and providing them free of charge by mail to any American who wants one.

MORE: 'This is a critical moment': Biden provides update on threat of omicron variant