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BioFire Diagnostics Receives FDA Clearance for FilmArray 2.0 System

NEW YORK (GenomeWeb) – BioMérieux today announced that its subsidiary BioFire Diagnostics has received US Food and Drug Administration clearance and CE-IVD marking for the FilmArray 2.0 system.

The PCR-based platform has higher throughput, processing up to 175 samples per day, and a smaller footprint, the firm said in a statement. It will be commercially available by the end of March.

The platform's test menu includes a respiratory panel, a blood culture identification panel, and a gastrointestinal panel that was cleared by the FDA in May 2014.

BioFire said it expects to submit a meningitis-encephalitis panel to the FDA later this year.

"As we develop additional applications for the FilmArray system, it is essential that customers are able to accommodate high throughput with as small of a footprint as possible," BioFire CEO Randy Rasmussen said in a statement.

BioFire Defense, also a BioMérieux company, received FDA Emergency Use Authorization for two Ebola FilmArray tests in October 2014.