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BioFire Receives FDA Clearance for the FilmArray 2.0

BioWatch Trigger DetectorBioFire Diagnostics, LLC today announced that it has received FDA clearance and CE-IVD marking of the FilmArray 2.0 system. The system is expected to be commercially available by the end of March 2015.

Since its acquisition by bioMérieux, BioFire Diagnostics has reported more than 60% organic growth in sales at the end of 2014.

FilmArray 2.0 features higher throughput, allowing customers random access processing up to 175 samples in a day within a small footprint. The system offers the same strengths of rapidity, ease-of-use, integration and accuracy that characterize the current FilmArray. Each system accommodates 1 to 8 FilmArray 2.0 units operated by a single computer. The system is also capable of connecting to Laboratory Information Systems.

“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,” said Randy Rasmussen, bioMérieux Corporate Vice President of Molecular Biology and CEO of BioFire Diagnostics. “We look forward to introducing the FilmArray 2.0 system to clinical laboratories throughout the world and are excited for the expected benefits FilmArray’s syndromic approach will have on the fight against infectious diseases, antibiotic stewardship and more broadly on patient care and healthcare cost reduction.”

Currently, the FilmArray menu includes three FDA-cleared and CE-marked panels: the Respiratory Panel, the Blood Culture Identification Panel and the Gastrointestinal Panel.

Additionally, BioFire has initiated studies for its Meningitis-Encephalitis Panel, with FDA submission expected this year.

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