|Paul Schreckenberger, PhD|
BioFire Diagnostics Inc, Salt Lake City, which has received FDA clearance for its FilmArray Blood Culture Identification (BCID) Panel, notes that the 27-target panel is the most comprehensive test to be approved by the FDA to date.
The panel is designed to help hospitals identify bloodstream infection-causing organisms more rapidly than conventional identification methods. 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.
The panel provides results from positive blood cultures, and can identify more than 100 blood pathogens known to cause sepsis. For each hour that severe sepsis goes untreated, the average mortality rate increases by 7.6%, making timely diagnosis and administration of appropriate therapy imperative for positive patient outcomes.
“We have made it a top priority this year to significantly reduce deaths caused by sepsis, and we plan to use diagnostic tools to help us achieve this goal,” says Paul Schreckenberger, PhD, director of the Clinical Microbiology Laboratory, Loyola University Medical Center, Chicago. “The faster we get test results, the faster we will be able to apply an optimized treatment plan, thus improving overall patient outcomes including reduced deaths, costs, and the length of patient hospital stays.”
With an easy procedure requiring only 2 minutes of hands-on time, the BCID Panel can identify a pathogen in nine out of 10 positive blood cultures in about an hour, and provides results for gram-positive bacteria, gram-negative bacteria, and yeast that cause bloodstream infections.
The panel also 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. In addition, the panel tests for common antimicrobial resistance genes associated with Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococci (VRE).
[Source: BioFire Diagnostics]