Skip to main content
Premium Trial:

Request an Annual Quote

BioMérieux's BioFire Unit Submits Meningitis/Encephalitis Panel for FDA Clearance

NEW YORK (GenomeWeb) – BioMérieux said today that its BioFire subsidiary has submitted a de novo classification request to the US Food and Drug Administration for the FilmArray Meningitis/Encephalitis (ME) panel.

FilmArray ME tests cerebrospinal fluid for the most common bacteria, viruses, and fungi responsible for community-acquired meningitis or encephalitis. The panel takes about an hour to run on BioFire's FilmArray molecular testing platform, a fully automated system that combines highly multiplexed PCR and melt curve analysis.

BioFire made the de novo submission after successfully completing a clinical study that included more than 1,500 prospective samples analyzed at 11 different sites across the US, including a representative mix of pediatric and adult patients. At the Association for Molecular Pathology annual meeting in November, Paul Schreckenberger, a clinical researcher at Loyola Medicine who led one of the FilmArray ME test sites, shared some early positive data from his group's evaluation of the panel.

If the panel gains FDA clearance, it will be the fourth clinical diagnostic panel to run on the FilmArray system, joining FDA-cleared and CE-marked respiratory, blood culture identification, and gastrointestinal panels.

The Scan

Polygenic Risk Score to Predict Preeclampsia, Gestational Hypertension in Pregnant Women

Researchers in Nature Medicine provide new mechanistic insights into the development of hypertensive disorders of pregnancy, which may help develop therapeutics.

New Oral Nanomedicine Strategy Targets Gut-Brain Axis to Treat IBD

A new paper in Science Advances describes a platform to design polyphenol-armored oral medicines that are effective at treating inflammatory bowel disease.

Phylogenetic Data Enables New Floristic Map

Researchers in Nature Communications use angiosperm phylogenetic data to refine the floristic regions of the world.

Machine Learning Helps ID Molecular Mechanisms of Pancreatic Islet Beta Cell Subtypes in Type 2 Diabetes

The approach helps overcome limitations of previous studies that had investigated the molecular mechanisms of pancreatic islet beta cells, the authors write in their Nature Genetics paper.