BioFire Diagnostics, Salt Lake City, the molecular biology affiliate of bioMérieux, Marcy l’Étoile, France, has received a de novo premarket notification (510(k)) clearance from FDA for its FilmArray meningitis/encephalitis (ME) panel.
Developed to address the critical need for quick and accurate identification of central nervous system infectious agents, the panel requires approximately 1 hour to test cerebrospinal fluid (CSF) for the 14 most common pathogens (six bacteria, seven viruses, and one yeast) responsible for community-acquired meningitis and encephalitis. Currently, testing CSF for multiple organisms is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests.
At the end of June 2015, the installed base of FilmArray systems reached 1,900 instruments, with year-over-year sales more than doubling.
Rodrigo Hasbun, MD, MPH, University of Texas.
“BioFire’s ME Panel has the potential to significantly impact patient treatment for cases of suspected meningitis,” says Rodrigo Hasbun MD, MPH, associate professor of medicine at the University of Texas Medical School, Houston. “In the United States, current diagnostics are underutilized and not available in a timely manner to alter the empirical treatment for the majority of patients, especially for those who may have viral meningitis and do not benefit from antibiotics.”
Randy Rasmussen, BioFire.
“The ME panel highlights the clinical impact that FilmArray brings to infectious disease testing,” says Randy Rasmussen, bioMérieux corporate vice president of molecular biology and chief executive of BioFire Diagnostics. “It quickly and efficiently provides physicians complex diagnostic information, helping them to rapidly diagnose severe infections.”
“The FilmArray ME panel further solidifies our leadership in syndromic infectious disease testing with now four IVD panels launched in 4 years,” Rasmussen adds.
Worldwide, more than 1.2 million people every year are affected by the bacterial form of meningitis, resulting in an estimated 120,000 deaths. Bacterial meningitis can occur suddenly in healthy people, and even with prompt diagnosis and treatment approximately 10% of patients may die and up to 20% may sustain permanent damage and disability.1
The ME panel is cleared for the FilmArray and FilmArray 2.0 systems and will be commercially available in the United States beginning in November. CE marking for the panel is anticipated shortly after its US launch.
For more information, visit BioFire.
REFERENCE
- Facts about meningitis [online]. Perth, Australia: Confederation of Meningitis Organizations, 2015. Available at: www.comomeningitis.org/facts-about-meningitis. Accessed October 9, 2015.
