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BioFire Files 510(k) Submission to FDA for Blood Culture Panel

NEW YORK (GenomeWeb News) – BioFire Diagnostics today announced the 510(k) submission of its FilmArray Blood Culture Identification, or BCID, Panel to the US Food and Drug Administration.

The submission follows the successful completion of clinical trials for the panel, which provides automatic results for the most common infectious causes of sepsis. BioFire said that pending clearance from FDA, it anticipates launching the panel in the summer.

The panel simultaneously tests positive blood cultures for about 90 percent of the gram-positive bacteria, gram-negative bacteria, and yeast microbes that cause bloodstream infections. Additionally, it tests for common antimicrobial resistance genes associated with methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococci, and carbapenem-resistant Enterobacteriaceae.

BioFire noted that a timely diagnosis and administration of treatments can reduce mortality rates, hospital stays, and healthcare costs resulting from sepsis.

"We believe the availability of the BCID Panel, the FDA-cleared Respiratory Panel and our gastrointestinal and meningitis panels will continue to increase the utility of the FilmArray in the hospital clinical laboratory," BioFire CEO Kirk Ririe said in a statement.

Formerly called Idaho Technology, BioFire received FDA clearance of its FilmArray Respiratory Panel in May 2011. FDA cleared five additional pathogens for the panel last year.