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BioFire receives FDA approval for blood culture identification panel

BioFire Diagnostics, a privately-held clinical diagnostics company, has received clearance from the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel.

The BCID Panel is intended to aid hospitals in quickly identifying the bloodstream infection-causing organisms compared to otherconventional identification methods. This in turn helps in minimiing the mortality rates, decreasing the hospital stays and reducing the overall costs caused by sepsis.

The FilmArray BCID Panel can identify over 100 blood pathogens that are known to cause sepsis. The average death rate caused by untreated sepsis is growing by 7.6% every hour, which necessitates timely diagnosis and administration of required therapy.

It uses an easy procedure to identify a pathogen in nine out of 10 positive cultures in just an hour. It is claimed to be the only test that offers results from the gram-positive bacteria, gram-negative bacteria and yeast that cause bloodstream infections.

BioFire Diagnostics CEO Kirk Ririe said, "Customer feedback on the BCID Panel has been extremely positive."

The BCID Panel also tests for common antimicrobial resistance genes linked with Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococci (VRE).

The 27-target panel is claimed to be the most comprehensive test that has been approved by the FDA.