Bloomberg News reports:
Roche Holding AG won emergency approval from the U.S. government for a highly automated coronavirus test, potentially speeding up tenfold the ability to test patients.
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.
This is the third test — and first commercially available one — granted emergency approval by the FDA. The agency in February cleared diagnostic tools brought forth by the CDC and the New York State Department of Public Health.