BioMerieux’s FilmArray Torch receives US and EU approval

BioMerieux has announced that its new FilmArray Torch system has been granted regulatory approval in the US and EU.

The US Food and Drug Administration has cleared FilmArray Torch for use with the FilmArray Blood Culture Identification Panel, Gastrointestinal Panel and Meningitis/Encephalitis Panel, while it has also received European CE Mark approval.

This high-throughput system is a fully integrated, random and continuous access multiplex PCR system for clinical laboratories of all sizes, providing up to six times more sample throughput per sq ft of benchtop space.

It integrates sample preparation, amplification and detection in a single closed system, requiring only two minutes of hands-on time, with a total run time of about an hour.

Randy Rasmussen, chief executive officer of BioFire Diagnostics and vice-president of molecular biology at BioMerieux, said: "The high-throughput FilmArray Torch is a major step forward in the global shift toward the syndromic diagnosis of infectious diseases and reinforces our leadership in this market."

The FilmArray Torch system is expected to be an important driver of growth for BioMerieux when it hits the market over the summer.