TUESDAY, SEPTEMBER 27, 2016

FilmArray Meningitis/Encephalitis Panel receives FDA clearance

FilmArray Meningitis/Encephalitis Panel receives FDA clearance. | Courtesy of biothreatsmitre.org
BioMerieux, a global leader in vitro diagnostics, recently announced that its molecular biology affiliate, BioFire Diagnostics, has received a de novo clearance from the U.S. Food and Drug Administration (FDA) for the FilmArray Meningitis/Encephalitis (ME) Panel.

The expanded menu and fourth panel of FilmArray makes it the largest that is currently available in a molecular biology multiplex platform. The new panel is unique with its highly beneficial medical value. It is the first of its kind that can address the important unmet need for fast, efficient identification of infectious agents in the central nervous system.

"BioFire’s ME Panel has the potential to significantly impact patient treatment for cases of suspected meningitis," Dr. Rodrigo Hasbun, MPH, associate professor of medicine at the University of Texas Medical School in Houston, said.

The technology uses a comprehensive panel test to sample cerebrospinal fluid (CSF) for the most common six viruses, six bacteria, and one yeast pathogens that cause meningitis or encephalitis.

“The ME Panel highlights the clinical impact the FilmArray brings to infectious disease testing,” Randy Rasmussen, bioMérieux corporate vice president of molecular biology and CEO of BioFire Diagnostics, said. “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 four years.”

Organizations in this story

Biofire Diagnostics ,

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903

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