FDA Issues Emergency Authorization for Swiss Company’s Coronavirus Test

The federal Food and Drug Administration (FDA) has approved emergency authorization of a coronavirus test made by Swiss diagnostic developer Roche.

The tests provide results in less than four hours and can produce up to 4,128 results in 24 hours, according CNBC reporting:

The FDA’s Emergency Use Authorization allows the tests to be deployed in markets including the United States as well as others accepting the CE mark signifying they conform to European directives.

U.S. health regulators have approved a new coronavirus test that will speed up by tenfold the ability to test patients, helping solve a significant obstacle to American efforts to contain the virus.

“We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, head of the Swiss drugmaker’s diagnostics unit, said in an interview, according to Bloomberg:

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.

Roche’s cobas systems, launched in 2014, are widely available globally, with 695 of the 6800 instruments and 132 of the 8800 systems already installed.

There are 110 of these tools in the U.S., and Roche has installed a “significant amount” of new ones in key locations in the U.S. in recent weeks, Schinecker said. 

“The tests analyze nucleic acids extracted from patients’ saliva or mucus, and compare them against sequences found in coronavirus strains, including SARS and the one that emerged in Wuhan, China,” Bloomberg reported.

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