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Higher Throughput BioFire FilmArray System, Respiratory Panel Receive FDA Clearance

NEW YORK (GenomeWeb) – BioMérieux molecular biology affiliate BioFire Diagnostics announced today that it has received special 510(k) clearance from the US Food and Drug Administration for the Film Array Torch system, for use with the FilmArray Respiratory Panel.

The Torch, a higher throughput multiplex PCR system, was submitted by the firm for 510(k) clearance in mid-January. The company expects the system to be commercially available in the US this summer, and in Europe in the second half of 2016.

BioFire also announced today it has submitted special 510(k) applications for three other assays for use with the Torch system — the Blood Culture Identification, Gastrointestinal, and Meningitis/Encephalitis FilmArray panels.

"FDA clearance of the FilmArray Torch with FilmArray Respiratory Panel and FDA submission for use with additional FilmArray panels within two weeks of each other highlight the strength of our development team and product pipeline," CEO Randy Rasmussen said in a statement. "As the clinical and economic benefits of frontline syndromic infectious disease testing for upper respiratory tract infections continues to be demonstrated in hospitals around the world, customers require increased sample throughput — the FilmArray Torch delivers just that."

The Torch provides up to six times more throughput than BioFire's current system. It consists of scalable modules, such that a two-module system can test 42 patient samples per day, while a 12-module system can handle 262 samples. The system is also fully integrated, random and continuous access, and has a "radically smaller footprint," the firm said.

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