The Roche rapid coronavirus test will launch in Europe in September, and it will be used for point-of-care settings for asymptomatic and symptomatic patients.
The Roche rapid coronavirus test usually reveals the results in about 15 minutes. Accordign to the company, the test accurately presents diagnosis of an infected Covid-19 patient more than 96% of the time. It also presents a negative result more than 99% of the time, based on a combined sample size of 426 samples from two different 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 said that the test is “affordable” but did not reveal its price. The company clarified that it does not require technical lab equipment. The test can also be used where rapid and large-scale testing are needed.
Roche pointed out that the company plans to seek an emergency use authorization from the US Food and Drug Administration. The test will be distributed to countries that acknowledge the CE regulatory marking, which are the member states of the European Union.
Only a healthcare professional can perform the Roche rapid coronavirus test, according to the company. However, the advantage is that the test does not require a clinical lab, making the time to produce results shorter.
“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.”
SD Biosensor
When the test gets introduced at the end of the month, Roche said it will be able to deliver 40 million tests every month and it plans to double that capacity by the end of 2020. Roche also said it came up with 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," he said.
Meanwhile, American medical device company Abbott Labs said that their new rapid test was granted an emergency authorization by the FDA last week. Abbott added that the test will cost about $5 and can produce results in minutes.
However, the FDA only allowed that test for use on symptomatic patients within seven days. HHS officials pointed out that the test can be used on an off-label basis with the guidance of local health officials to screen people who do not manifest any symptoms.
The Trump administration sealed at least 150 million of the tests as part of a deal worth over $750 million.
