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Roche to launch new rapid coronavirus test in Europe later this month following regulatory clearance

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A photo showing the logo of Swiss pharmaceutical giant Roche in Basel.

SEBASTIEN BOZON | AFP | Getty Images

Swiss pharmaceutical company Roche announced Tuesday that it will launch its new rapid coronavirus test in Europe at the end of the month. 

The antigen test will be used in point-of-care settings for both asymptomatic and symptomatic patients, the company said. It added that the test typically yields results in about 15 minutes.

The company said the test accurately diagnoses an infected Covid-19 patient more than 96% of the time and accurately shows a negative result more than 99% of the time, based on a combined sample size of 426 samples from two separate testing centers.

Roche said the company intends to apply for an emergency use authorization from the U.S. Food and Drug Administration. At the end of September, the test will be available in countries that recognize the CE regulatory marking, which are the member states of the European Union, it said.

“This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes,” Roche said in a statement. “In addition, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high risk environment.”

The test is meant to be performed by a healthcare professional, the company said, but the advantage is that it does not need to be performed in a clinical lab, cutting down the time it takes to produce results.

When the test launches at the end of the month, the company said it will be able to produce 40 million tests every month and it hopes to double that capacity by the end of the year.

Roche said it launched the test in partnership with SD Biosensor. 

“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” Roche’s CEO Thomas Schinecker said in a statement. “COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus.”

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