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FDA Clears BioFire's Sepsis Panel

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared BioFire Diagnostics' FilmArray Blood Culture Identification, or BCID, Panel, the company announced today.

The FDA clearance follows CE marking of the 27-target panel earlier this month. The Salt Lake City company filed its 510(k) submission to FDA for the test in April.

According to BioFire, the panel provides results from positive blood cultures and can identify more than 100 blood pathogens known to cause sepsis. It is designed to help hospitals identify organisms that cause blood stream infections more rapidly than can be achieved with other current methods.

It can identify a pathogen in nine out of 10 positive blood cultures in about one hour and is the only test that can provide results for gram-positive bacteria, gram-negative bacteria, and yeast that cause bloodstream infections, BioFire said.

It added that BCID includes the first FDA-cleared diagnostic test for the blaKPC gene, which is associated with carbapenem resistance in Klebsiella pneumoniae, Acinetobacter spp, and carbapenem-resistant Enterobacteriaceae. It also tests for common antimicrobial resistance genes associated with methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.

"We expect an immediate increase in revenues since existing FilmArray customers have indicated that they intend to adopt the BCID Panel," BioFire CEO Kirk Ririe said in a statement.