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Roche Quantitative, Qualitative SARS-CoV-2 Test Gets FDA Emergency Use Authorization

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

The test, which Roche said is the first automated real-time, RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens, was authorized for use with the Cobas 6800/8800 systems. According to Roche Diagnostics CEO Thomas Schinecker, the test will allow users to simultaneously detect the SARS-CoV-2 virus and measure the viral load in an individual suspected of having the virus.

"The test's performance suggests that, by earlier and more accurately identifying infected patients, the results may open the path for healthcare providers to more efficiently organize their therapeutic and monitoring interventions," he said in a statement.

The Cobas SARS-CoV-2 Duo test is expected to be available in the US in the current quarter and is for use by a healthcare provider. Roche noted that only the qualitative result of the test is intended for use as an aid in diagnosing an individual with COVID-19.

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