BioFire Diagnostics begins studies of pathogen panel for FDA approval
BioFire plans to gain both U.S. Food and Drug Administration approval and CE IVD marketing, the company said in a press release.
"The commencement of studies to evaluate our meningitis test is exciting since the FilmArray has the potential to make a profound impact on treating this fatal disease where symptoms can appear suddenly and escalate quickly," Randy Rasmussen, the CEO of BioFire Diagnostics, said. "We look forward to introducing the ME Panel to clinical laboratories throughout the world."
The ME Panel, which is the fourth diagnostic test to run on the FilmArray system, has a run time of approximately one hour. The panel can simultaneously search for 16 different bacterial and fungal pathogens known to cause community-acquired meningitis and encephalitis.
The study is being conducted at various hospital-based clinical laboratories throughout the U.S. BioFire Diagnostics expects to make its submission to the FDA next year.
BioFire Diagnostics will exhibit the FilmArray system during the Association of Clinical Chemistry annual meeting from July 29-31 in Chicago, Ill.
The company holds approximately 90 patents related to polymerase chain reaction and has sold approximately 200 products to the clinical research and military markets.