bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its molecular biology affiliate, has received 510(k) clearance from the FDA for the FilmArray® Respiratory Panel 2 (RP2). The FilmArray® RP2 tests for 21 pathogens (17 viruses and 4 bacteria) responsible for respiratory tract infections and will be commercially available by mid-June 2017. This follows the announcement in April that the FilmArray® Respiratory Panel 2 plus (RP2plus) is CE marked. The FilmArray® RP2plus contains one more pathogen than FilmArray® RP2 - the Middle East Respiratory Syndrome coronavirus (MERS-CoV). The FilmArray® RP2plus has been submitted as a de novo application to the US FDA.
The FilmArray® RP2 advances the existing FilmArray® Respiratory Panel (RP) by reducing the assay time from about an hour to less than 45 minutes, while also improving overall sensitivity and enhancing several assays. FilmArray® RP2 also includes an additional pathogen, Bordetella parapertussis. B. parapertussis represents a significant cause of whooping cough and is often missed because of a clinical presentation largely indistinguishable from other viral infections and a lack of reliable diagnostic tests.
Randy Rasmussen, bioMérieux Corporate Vice President of Molecular Biology and CEO of BioFire Diagnostics, said: “A growing body of evidence strongly supports the added medical value of rapid syndromic infectious disease testing enabled by BioFire’s market leading technology. Reducing the turnaround time of FilmArray® Respiratory Panel 2 demonstrates bioMérieux’s continued commitment to empower FilmArray® users to better serve patients and improve outcomes.”
Judy Daly, Ph.D., Professor of Pathology at the University of Utah and Director of Microbiology Laboratories at Primary Children’s Medical Center in Salt Lake City, Utah was the principal investigator at one site for the FDA clinical studies of FilmArray® RP2. Dr. Daly states: “The FilmArray® Respiratory Panel 2 assay is robust, simple-to-use, and provides rapid detection of 21 respiratory pathogens in about 45 minutes. In our experience, the FilmArray® RP2 enables us to provide faster, more accurate, and more comprehensive results and helps improve detection of respiratory pathogens and clinical actionability”.
The FilmArray® RP2 is compatible for use on the FilmArray® 2.0 and FilmArray® Torch systems. The Company plans to continue to make the current FilmArray® RP panel commercially available.