Roche to launch rapid coronavirus test in Europe by end of month
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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.
