FDA Grants Emergency Authorization For New, High-Speed Wuhan Virus Test

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Posted: Mar 13, 2020 8:14 AM
FDA Grants Emergency Authorization For New, High-Speed Wuhan Virus Test

Source: Kim Sun-woong/Newsis via AP

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.

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)

There are more than 100 of the company’s systems in the U.S. and more have been installed in recent weeks.

“We definitely extended the capacity of the testing significantly throughout the U.S,” Schinecker told Bloomberg. 

The 6800/8800 system can have tests for the virus back within four hours and according to the company, they are “going to the limits of ... production capacity” for the tests, and can currently provide millions of them each month.