FDA grants emergency approval for faster coronavirus test

The U.S. Food and Drug Administration (FDA) has granted diagnostics giant Roche Holding AG an emergency approval for an automated coronavirus test, which the company said could increase testing tenfold for the virus that has reached pandemic levels.

The FDA granted an “emergency use authorization” to the test, which functions on Roche’s cobas 6800/8800 systems, Bloomberg News reported. The 8800 system can test up to 4,128 patients a day. The 6800 system can test as many as 1,440 a day, the Switzerland-based company confirmed. 

“We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, head of Roche’s diagnostics unit, told Bloomberg News.

This is the first commercially available test granted emergency approval by the FDA. The agency approved diagnostic tools from the Centers for Disease Control and Prevention and the New York State Department of Public Health last month.

Roche’s cobas systems are available around the world, according to Bloomberg News. There are 695 of the 6800 instruments and 132 of the 8800 systems installed. There are 110 of these systems in the United States, and the company said it installed a “significant amount” in the country in recent weeks.

The two systems are able to provide test results within four hours. The company said it is “going to the limits of its production capacity,” Bloomberg News reported.

The company declined to comment on pricing for the tests to the outlet. 

“We definitely extended the capacity of the testing significantly throughout the U.S.,” Schinecker told Bloomberg News. The company also had an existing test for the coronavirus, but the cobas 8800 system can test patients approximately 10 times faster.