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Tuesday, August 9th, 2022

FDA issues emergency use authorization for Roche’s cobas SARS-CoV-2 Duo

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Roche broke new ground with its cobas SARS-CoV-2 Duo, which this week received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) to become the first PCR test capable of simultaneously detecting COVID-19 and quantitatively measuring viral load levels.

“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,” Thomas Schinecker, CEO of Roche Diagnostics, said.

The Duo test is automated and real-time, uniting the qualitative result of traditional SARS-CoV-2 PCR tests with a quantitative measurement of an individual’s viral load. This could help healthcare professionals, in turn, better undertake contact tracing, patient triage, and medical care for infected patients. The test utilizes nasal and nasopharyngeal swab specimens for its analyses.

According to Roche, it should be available throughout the United States this quarter.