Roche: Received Emergency Use Authorization from FDA


(CercleFinance.com) – Roche announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for cobas SARS-CoV-2 Duo for use in cobas 6800 systems. /8800 fully automated, expanding the Roche COVID-19 portfolio.

It is the first automated real-time RT-PCR test for the qualitative and quantitative in vitro detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.

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

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