NEW YORK (GenomeWeb) – BioMérieux today announced its molecular biology affiliate BioFire Diagnostics has received clearance from the US Food and Drug Administration for three additional molecular diagnostics panels on its high-throughput FilmArray Torch platform.
The Torch platform is a fully integrated, random and continuous access multiplex PCR system that provides up to six times more throughput compared to the firm's FilmArray system. It was cleared with the company's Respiratory Panel in February, and the current clearance now adds the Blood Culture Identification, Gastrointestinal, and Meningitis/Encephalitis panels, which were all previously cleared on the lower-throughput FilmArray system.
Both platforms run closed-system assays that integrate sample preparation, amplification, and detection, require two minutes of hands-on time, and have a total run time of about an hour.
BioMérieux also announced today that the FilmArray Torch has been CE marked.
"With the CE marking of the system, four FDA-cleared panels and more to come, 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," CEO of BioFire Diagnostics and VP Molecular Biology at BioMérieux Randy Rasmussen said in a statement.
The number of FilmArray systems installed globally increased by more than 1,000 last year to reach about 2,500, and FilmArray revenues grew rapidly year over year, the firm further noted. The Torch system will be introduced in the coming days at the European Congress of Clinical Microbiology and Infectious Diseases being held in Amsterdam, The Netherlands.