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BioMérieux BioFire Respiratory Panel With SARS-CoV-2 Target Nabs CE Mark

NEW YORK – BioMérieux announced Wednesday that its BioFire Respiratory Panel 2.1 plus, which tests for SARS-CoV-2 and other respiratory infections, received CE marking.

The panel tests for 23 pathogens encompassing 19 viruses, including SARS-CoV-2 and Middle East Respiratory Syndrome Coronavirus, and four bacteria that result in the most frequent respiratory tract infections. The new test, whose earlier version received Emergency Use Authorization from the US Food and Drug Administration in May, adds SARS-CoV-2 to the BioFire Respiratory Panel 2 plus with the same runtime of approximately 45 minutes, the firm said. 

The company said in a statement the test will be available in all countries recognizing CE marking starting now or "shortly thereafter." It runs on the BioFire FilmArray 2.0 and BioFire FilmArray Torch systems, and CEO Pierre Boulud said there are more than 14,000 BioFire units installed globally.

In March, the company received EUA for subsidiary BioFire Diagnostics' rapid COVID-19 assay that runs on both FilmArray systems. In May, the firm received EUA for its high-complexity molecular diagnostic test for SARS-CoV-2.