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Roche: Cobas SARS-CoV-2 Test Granted FDA Emergency Use Authorization

Roche (RHHBY) said the U.S. FDA has issued an Emergency Use Authorization for the cobas SARS-CoV-2 Test for the qualitative detection of SARS-CoV-2, the novel coronavirus. Roche said Hospitals and reference laboratories can run the test on the company's fully automated cobas 6800 and cobas 8800 Systems. The cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results in three and half hours.

Roche noted that the CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease.

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