Roche (RHHBY) announced that the Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the cobas SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing, the company said in a statement.

Hospitals and reference laboratories can run the test on Roche's fully automated cobas 6800 and cobas 8800 Systems, which the company says are widely available in the U.S. and around the world.

The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present, Roche added. "We are increasing the speed definitely by a factor of 10," Thomas Schinecker, head of Roche's diagnostics unit, told Bloomberg in an interview.