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Roche announced today that it received FDA emergency use authorization (EUA) for its cobas SARS-CoV-2 Duo diagnostic.

Authorization covers the cobas SARS-CoV-2 Duo on the fully automated cobas 6800/8800 systems, expanding Roche’s COVID-19 portfolio and representing the first automated, RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.

The assay performs quantitation of SARS-CoV-2 RNA levels in the connected specimen, while only the qualitative result of cobas SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider.

Basel, Switzerland-based Roche said in a news release that the potential benefits from reporting a standard viral load along with the qualitative result may help clinicians assess and monitor infected patients across laboratories over time.

The company plans to make the test available in the U.S. by the second quarter of 2022.

“With the SARS-CoV-2 Duo test, we are now able to detect the COVID-19 virus and simultaneously measure the viral load in an individual,” Roche Diagnostics CEO Thomas Schinecker said in the release. “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.”

Filed Under: Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: FDA, Roche, Roche Diagnostics

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