FDA Clearance for the FilmArray® Blood Culture Identification Panel
BioFire Diagnostics have received FDA clearance for 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 rapidly identify more than 100 blood pathogens known to cause sepsis. 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 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 percent of infected patients. The BCID Panel also tests for common antimicrobial resistance genes associated with Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococci (VRE).
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Source : BioFire Diagnostics, Inc.™ [USA]
Now part of BioFire Diagnostics, Inc. View Company Information
Posted on July 2, 2013