BioFire currently offers the FDA-cleared and CE IVD marked FilmArray Respiratory Panel, Blood Culture Identification Panel, and Gastrointestinal Panel. About BioFire Diagnostics, LLCīioFire Diagnostics, LLC, a wholly owned subsidiary of bioMérieux, Inc., manufactures and distributes the user-friendly FilmArray System to hospital-based clinical laboratories throughout the world. The ME Panel will be the fourth clinical diagnostic test to run on the FilmArray System.Īdditionally, BioFire will be exhibiting the FilmArray at booth 1257 during the 2014 American Association of Clinical Chemistry (AACC) annual meeting July 29-31 in Chicago, IL. BioFire expects the FDA submission in 2015. The clinical study is being conducted at numerous hospital-based clinical laboratories in the U.S. “We look forward to introducing the ME Panel to clinical laboratories throughout the world.” “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,” said Randy Rasmussen, bioMérieux Corporate VP Molecular biology and CEO of BioFire Diagnostics. With a run time of about an hour, the comprehensive ME Panel requires only 200 μl of cerebrospinal fluid (CSF) to test simultaneously for 16 different bacterial, viral, and fungal pathogens known to cause community-acquired meningitis and encephalitis. However, clinical diagnosis of the meningitis syndrome is difficult since their signs and symptoms are virtually indistinguishable. Conversely, viral meningitis is more common, but typically mild and non-lethal. Acute bacterial meningitis is a rare, but potentially fatal disease. Infection of the meninges surrounding the brain and spinal cord (meningitis), or of the brain (encephalitis) can have high mortality and morbidity rates depending on the source of infection. Molecular test will quickly identify infectious causes of meningitis and encephalitis.īioFire Diagnostics, LLC, bioMérieux’s molecular biology affiliate, announced today that it has commenced clinical and analytical studies to evaluate the company’s FilmArray Meningitis/Encephalitis (ME) Panel, with plans to seek both FDA clearance and CE IVD marking.
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