Date: Jul 16, 2013 Source: (
click here to go to the source)
BioFire Diagnostics, Inc., announced today the FDA clearance of its FilmArray Blood Culture Identification (BCID) Panel. To date, the 27-target panel is the most comprehensive test to be approved by the FDA.
The FilmArray BCID 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 percent, making timely diagnosis and administration of appropriate therapy imperative for positive patient outcomes.
The BCID 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.
With an easy procedure requiring only two 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 is the only test that provides results for gram-positive bacteria, gram-negative bacteria and yeast that cause bloodstream infections.
In addition, the panel includes the first FDA cleared diagnostic test for theblaKPC 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 percent of infected patients. The BCID Panel also tests for common antimicrobial resistance genes associated with Methicillin-resistantStaphylococcus aureus (MRSA) and Vancomycin-resistant Enterococci (VRE).
www.BioFireDx.com
Daily News Watch Archives
