BioFire Gets FDA Clearance, CE Mark for FilmArray 2.0

French in vitro diagnostics maker bioMérieux announced Thursday that its molecular biology affiliate, BioFire Diagnostics, received FDA clearance and CE-IVD marking for its FilmArray 2.0 system. The system is expected to be commercially available in the U.S. and EU by the end of March.

FilmArray is a polymerase chain reaction closed-system that integrates all molecular diagnostic steps, from sample preparation through amplification, detection and analysis. The 2.0 version features higher throughput, allowing for processing of up 175 samples a day, bioMérieux said, while offering the same rapidity, ease-of-use, integration and accuracy as its predecessor. Running the system requires only two minutes of hands-on time, with a total run time of about an hour, the company added.

Each system accommodates one to eight FilmArray 2.0 units operated by a single computer and can also connect to laboratory information systems, the firm said. The system’s menu includes three FDA-cleared and CE-marked panels: respiratory, blood culture identification and gastrointestinal. A meningitis-encephalitis panel is currently being evaluated, with FDA submission expected this year, the company said. — Kellen Owings