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BioMérieux Nabs CE Mark for RT-PCR SARS-CoV-2, Influenza A/B Assay

NEW YORK – BioMérieux said on Wednesday that it has received CE marking for its SARS-COV-2 Respi R-Gene test, which tests for SAR-CoV-2 and other respiratory infections.

BioMérieux's new assay simultaneously detects SARS-CoV-2 and influenza viruses A and B. Within each test kit is a cellular control to check the quality of the sample, and the kit comes with a second real-time PCR analysis to detect human respiratory syncytial virus and human metapneumovirus.

The French firm said that the new assay can be performed by any laboratory using PCR technology on commercially available nucleic acid extraction and amplification platforms. The test can produce results within four to five hours.

"Infections caused by respiratory viruses often have similar symptoms, but patient management may differ," François Lacoste, executive VP of R&D at BioMérieux, said in a statement. "Although the circulation of flu viruses is low to date, in light of the COVID-19 pandemic, it is even more important to detect other diseases associated with respiratory disease early on, especially for high-risk patient groups."

BioMérieux was previously granted Emergency Use Authorization by the US Food and Drug Administration earlier this month for its SARS-CoV-2 assay developed by its subsidiary BioFire Defense for use with pooled samples.