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NEW YORK – Roche said on Friday that the US Food and Drug Administration has issued Emergency Use Authorization for the Cobas SARS-CoV-2 Test.

The test, which is also CE-IVD marked, is for patients who show signs and symptoms of the disease COVID-19, caused by the SARS-C0V-2 coronavirus. It is for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the clinical and epidemiological criteria for testing, and can be used with Roche's fully automated Cobas 6800 and Cobas 8800 systems.

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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.