BioFire Diagnostics said this week that it has received the CE IVD mark for its FilmArray Blood Culture Identification Panel.
The BCID Panel tests positive blood cultures and can identify more than 100 blood pathogens known to cause sepsis. The assay requires two minutes of hands-on time, and can identify pathogens in nine out of 10 positive blood cultures in about one hour.
BioFire said that it is the only test that provides results for gram-positive bacteria, gram-negative bacteria, and bloodstream infection-causing yeast. In addition, the BCID Panel 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 will provide physicians with information that can help to guide more timely selection of appropriate antimicrobial treatments, the company said.