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.”