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Home » Roche secures emergency use authorization for coronavirus test

Roche secures emergency use authorization for coronavirus test

March 13, 2020 By Chris Newmarker

Roche coronavirus test
[Images courtesy of Roche]
Roche (SWX: RO,  ROG) announced today that its Cobas SARS-CoV-2 test is the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic.

The tests are also now available in countries accepting the EU’s CE Mark.

FDA didn’t object to Roche pre-positioning its test, so labs are now able to initiate testing immediately. The tests run on 827 high-volume Cobas 6800/8800 systems that Roche has installed around the world. Roche will now have millions of tests available per month to run on the machines, the company said.

The influx of tests is welcome news. Public health authorities in the U.S. have been struggling to grasp the spread of COVID-19 in the country amid a shortage of available tests for the SARS-CoV-2 virus that causes it.

“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” Roche Diagnostics CEO Thomas Schinecker said in a news release.

The SARS-CoV-2 test can provide test results in thee and a half hours. A Cobas 6800 system can produce 1,440 results in 24 hours; a Cobas 8800 system can produce 4,128.

Also today, the FDA said it was not objecting to the New York State Department of Health authorizing certain laboratories in the state to begin patient testing after validating their tests and notifying the NYSDOH.

The agency touted its efforts to boost the supply of coronavirus tests.

“We have been encouraging test developers to come to the FDA and work with us,” said Dr. Jeff Shuren,  director of the FDA’s Center for Devices and Radiological Health.

“Since the beginning of this outbreak, more than 60 developers have sought our assistance with development and validation of tests they plan to bring through the emergency use authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency.”

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: coronavirus, FDA, Roche, Roche Diagnostics

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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