BioFire receives FDA clearance for the FilmArray Blood Culture Identification Panel

July 3, 2013

BioFire Diagnostics, Inc., has announced the FDA clearance of its FilmArray Blood Culture Identification (BCID) Panel. The 27-target panel provides results from positive blood cultures, and can identify more than 100 blood pathogens known to cause sepsis. The BCID Panel is designed to help hospitals identify bloodstream infection-causing organisms rapidly. Rapid identification of pathogens in positive blood cultures has been shown to reduce mortality rates, shorten hospital stays, and lower overall costs due to sepsis.

With a procedure requiring only two minutes of hands-on time, the BCID Panel can identify a pathogen in nine out of 10 positive blood cultures in about an hour. It provides results for gram-positive bacteria, gram-negative bacteria, and yeast that causes bloodstream infections.

In addition, the panel includes the first FDA cleared diagnostic test for the blaKPC gene, which is linked to carbapenem resistance in Klebsiella pneumoniae, Acinetobacter spp and Carbapenem-resistant Enterobacteriaceae (CRE). Bloodstream infections with CREs are reported to kill up to 50% of infected patients. The BCID Panel also tests for common antimicrobial resistance genes associated with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE).

“Customer feedback on the BCID Panel has been extremely positive,” says Kirk Ririe, CEO of BioFire Diagnostics. There is a lot of excitement for this product among our clinical hospital laboratory customers and anticipation of the effect it will likely have on antibiotic stewardship, patient care, and cost reduction.” Read product information about the FilmArray BCID.