FDA issues EUA for Roche test to detect SARS-CoV-2, viral load

2019 05 15 20 52 2340 Lab Pcr Tubes Dna 400

Roche on Wednesday announced that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for its Cobas SARS-CoV-2 Duo assay for use on the Cobas 6800/8800 systems.

Roche said its test is 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.

"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 a statement. "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."

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