Utah-based BioFire Diagnostics has received the CE IVD Mark for its FilmArray blood culture identification (BCID) panel under the European Directive on in vitro diagnostic medical devices.
The panel tests positive blood cultures, with the ability to identify over 100 blood pathogens known to cause sepsis, a medical condition that has a mortality rate of between 10% and 38%.
If sepsisis left untreated, there is an 8% increase in mortality in each hour, making timely diagnosis and administration of the right the therapy vital.
According to studies, a quick identification of sepsis and the administration of appropriate therapy leads to a reduction in mortality rates, shorter hospital stays and lower overall costs.
The company claims that the panel has been designed to help hospitals identify bloodstream infection-causing organisms more quickly than with regular identification methods.
With the procedure taking just two minutes, the panel can identify pathogens in nine out of ten positive blood cultures in about an hour.
The company claims that this is the only test that offers results for gram-positive bacteria, gram-negative bacteria and yeast-causing bloodstream infections.
The BCID panel also detects four antimicrobial resistance genes, mecA, vanA, vanB and blaKPC, that are known to confer resistance to methicillin / oxacillin, vancomycin and carbapenems.
By identifying the resistance markers, physicians have information that will help them to select appropriate and timely antimicrobial treatment.
BioFire Diagnostics CEO Kirk Ririe said; "We are confident that the BCID Panel will assist hospitals in lowering patient mortality rates and shortening patient stays."