NEW YORK (GenomeWeb) — BioFire Diagnostics, a subsidiary of BioMérieux, said today that it has begun clinical and analytical studies to evaluate its FilmArray Meningitis/Encephalitis Panel with plans to seek both US Food and Drug Administration clearance and CE IVD marking.
Meningitis, inflammation of the meninges surrounding the brain and spinal cord, and encephalitis, acute inflammation of the brain, can be caused by a number of microorganisms and can have high mortality and morbidity rates. Acute bacterial meningitis is a rare but potentially fatal disease, while viral meningitis is more common but typically mild and non-lethal. However, clinical diagnosis is difficult since the signs and symptoms of these two types are virtually indistinguishable.
With a run time of about an hour, the FilmArray ME Panel requires only 200 µl of cerebrospinal fluid to test simultaneously for 16 different bacterial, viral, and fungal pathogens known to cause community-acquired meningitis and encephalitis.
"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, BioMérieux's corporate vice president for molecular biology and CEO of BioFire Diagnostics, said in a statement.
The clinical study is being conducted at numerous hospital-based clinical laboratories in the US. BioFire expects the FDA submission in 2015. It did not provide a timeline for potential CE IVD marking.
The ME Panel would be the fourth clinical diagnostic test to run on BioFire's FilmArray System, a fully automated molecular testing system that uses PCR and melt-curve analysis to simultaneously test for multiple infectious agents in about an hour. FilmArray already has FDA-cleared and CE-marked panels for respiratory disease, sepsis, and gastrointestinal disease. The company has also previously stated that it is developing a pneumonia panel for the platform.
Last week BioMérieux reported 4 percent organic revenue growth for the first half of 2014 driven in part by a nearly 10 percent spike in clinical molecular biology sales. However, the company noted that clinical molecular biology sales increased by 70 percent in 1H when including the contribution from BioFire, the acquisition of which BioMérieux finalized in January.
BioMérieux also said last week that it is working with pre-existing BioFire distributors to assume direct marketing of the FilmArray platform by local sales subsidiaries in eight European countries, likely beginning this month.
In the first half of 2014, BioMérieux placed 150 new FilmArray units, and as of June 30 the company said it had an installed base of more than 860 systems. The platform is now commercially available in the US, in 25 European countries that recognize CE marking, Hong Kong, Australia, Thailand, and other countries that do not require regulatory licenses. The firm is also currently seeking regulatory approval in other countries such as China, India, and Brazil.