Roche Gets Emergency Use Authorization for COVID-19 Test

March 13, 2020

The FDA has authorized Roche’s cobas SARS-CoV-2 novel coronavirus diagnostic test for emergency use, the third emergency use authorization the agency has granted to help combat the outbreak.

The diagnostic, which has already received CE Mark certification, uses nasal or throat samples to test for the rapidly spreading virus and runs on the company’s fully automated cobas 6800 and 8800 systems.

The agency said that it granted authorization within 24 hours of receiving the application and noted that the diagnostic test is the first commercially distributed test receive emergency authorization during the outbreak.

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