FDA Grants Emergency Authorization For New, High-Speed Wuhan Virus Test
Leah Barkoukis
Posted: Mar 13, 2020 8:14 AM
The Federal Drug Administration has given emergency clearance to diagnostics giant Roche Holding to develop a new, high-speed test for the coronavirus.
The company says the new system will vastly increase testing capabilities.
“We are increasing the speed definitely by a factor of 10,†Thomas Schinecker, head of Roche’s diagnostics unit, told Bloomberg News.
Dr. Dena Grayson
✔
@DrDenaGrayson
🚨Good news. FDA approves automated #coronavirus test that provides results in 4 hours. The new test runs on lab instruments that already exist in the US—each machine can process >4,000 tests per day.
The US has only run ~11,000 #COVID19 tests so far.https://www.bloomberg.com/news/articles/2020-03-13/roche-gets-clearance-for-coronavirus-test-that-s-10-times-faster …
The U.S. Food and Drug Administration granted an “emergency use authorization†to the test, which runs on Roche’s cobas 6800/8800 systems. The tool also is available in Europe and countries that accept its CE marking for medical devices, Roche said.
The 8800 version is capable of testing 4,128 patients a day, and the 6800 can test as many as 1,440, the Basel, Switzerland-based company said. Roche shares climbed as much as 4.9% early Friday, leading the Stoxx Europe 600 Index. (Bloomberg)
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https://townhall.com/tipsheet/leahbarkoukis/2020/03/13/fda-grants-emergency-authorization-for-new-wuhan-virus-test-n2564883
