BioFire gains FDA approval for FilmArray Blood Culture Identification Panel

25 June 2013 (Last Updated June 25th, 2013 18:30)

US-based clinical diagnostics company BioFire Diagnostics has received approval from the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel.

US-based clinical diagnostics company BioFire Diagnostics has received approval from the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel.

The 27-target panel provides results from positive blood cultures and is capable of identifying more than 100 blood pathogens known to cause sepsis.

The BCID Panel is designed to help hospitals detect bloodstream infection more rapidly than conventional methods, which can in turn lower mortality rates, shorten hospital stays and reduce the overall costs due to sepsis.

The test involves a procedure requiring only two minutes of hands-on time, and can detect a pathogen in nine out of ten positive blood cultures in about an hour.

BioFire Diagnostics noted that FilmArray BCID Panel is the only test that provides results for gram-positive bacteria, gram-negative bacteria and yeast that cause bloodstream infections.

The panel features 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).

The BCID Panel also tests for common antimicrobial resistance genes associated with Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococci (VRE).

BioFire Diagnostics CEO Kirk Ririe said that customer feedback on the BCID Panel has been extremely positive."

"There is a lot of excitement for this product among our clinical hospital laboratory customers and anticipation for the effect it will likely have on antibiotic stewardship, patient care and cost reduction," Ririe added.