BioFire Diagnostics LLC, Salt Lake City, molecular biology affiliate of bioMérieux, Marcy l’Etoile, France, has received FDA clearance of its special premarket notification (510(k)) to market the FilmArray Torch analyzer with the FilmArray respiratory panel (RP).
The company has also submitted special 510(k) notifications for use of additional FilmArray panels on the Torch system, including panels for blood culture identification, gastrointestinal infections, and meningitis/encephalitis. BioFire anticipates commercial availability of FilmArray Torch this summer in the United States, and in the second half of 2016 in Europe.
As BioFire’s latest advance in syndromic infectious disease testing, the FilmArray Torch analyzer provides up to six times greater sample throughput than the existing FilmArray instrument. Torch is a fully integrated, random and continuous access multiplex polymerase chain reaction (PCR) system designed to meet the throughput demands of any size hospital laboratory.
Randy Rasmussen, BioFire Diagnostics.
“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,” says Randy Rasmussen, CEO of BioFire Diagnostics.
The FilmArray RP is a comprehensive panel of 20 respiratory viruses and bacteria that is performed directly on nasopharyngeal swab-associated viral transport media.
“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,” adds Rasmussen. “The FilmArray Torch delivers just that.”
FilmArray is a multiplex PCR system that integrates sample preparation, amplification, and detection into one closed system. The FilmArray requires only 2 minutes of hands-on time and has a total run time of about 1 hour.
For more information, visit BioFire Diagnostics.
