Roche to launch new rapid coronavirus test in Europe later this month following regulatory clearance
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.
“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 release. “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.”
Roche called the test “affordable,” but did not disclose pricing details. It does not depend on technical lab equipment, the company said, which means it can be used in settings where rapid and large-scale testing may be needed.
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.
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.
“This is highly beneficial where timely decisions are needed or laboratory testing is inaccessible,” Roche said in the release. “The test will help to quickly identify people who are infected and allows better patient management as well as more effective use of healthcare resources.”
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.”
American medical device company Abbott Labs announced that their new rapid test received emergency authorization by the FDA last week. Abbott said that test will cost about $5 and can return results in minutes.
But the FDA only authorized that test for use on symptomatic patients within seven days of the onset of symptoms. HHS officials, however, have since clarified that the test can be used on an off-label basis at the direction of local health officials to screen people who don’t have symptoms.
Once the test was authorized, the Trump administration secured at least 150 million of them, roughly all of the company’s supply through 2020, as part of a deal valued at over $750 million.
