BioFire obtains CE IVD Mark for FilmArray Blood Culture Identification panel

June 13, 2013

BioFire Diagnostics, Inc., has obtained the CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its FilmArray Blood Culture Identification (BCID) panel.

The BCID panel tests positive blood cultures and can identify more than 100 blood pathogens known to cause sepsis. The FlimArray BCID panel is currently under review by the FDA, and a company spokesperson indicates that BioFire anticipates FDA clearance next month.

The FilmArray BCID Panel is designed to help hospitals rapidly identify bloodstream infection-causing organisms. Studies show that a quicker time to sepsis organism identification and appropriate therapy leads to reduced mortality rates, shorter hospital stays, and lower overall costs.

With a procedure requiring only two minutes of hands-on time, the BCID Panel can identify pathogens in nine out of 10 positive blood cultures in about one hour. It provides results for gram-positive bacteria, gram-negative bacteria, and yeast causing bloodstream infections. In addition, it detects four antimicrobial resistance genes, (mecA, vanA, vanB, and blaKPC) known to confer resistance to methicillin/oxacillin, vancomycin, and carbapenems. Identification of these resistance markers provides physicians with information that can help to guide selection of appropriate antimicrobial treatment.

Says BioFire CEO Kirk Ririe, “The addition of the BCID panel expands BioFire’s infectious disease diagnostic menu, and we are confident that it will assist hospitals in lowering patient mortality rates and shortening patient stays.” Review the BCID panel information sheet.