bioMérieux Submits Enhanced Biofire BCID2 Panel For FDA Clearance

bioMérieux has announced that BioFire Diagnostics, its molecular biology affiliate, has submitted to the Food and Drug Administration for 510(k) clearance of the Biofire Blood Culture Identification 2 (BCID2) Panel. The Panel includes several additional pathogens, an expanded list of antimicrobial resistance genes, and many revised targets compared to the existing Panel. The existing Biofire BCID Panel, available since 2013, along with Biofire’s portfolio of syndromic tests, have changed lab workflow and patient management across multiple disease states. The new generation of the Biofire BCID Panel includes 26 bacteria, 7 yeasts, and 10 antimicrobial resistance genes. These comprise emerging pathogens, such as Candida auris, as well as new targets to more accurately identify methicillin-resistant Staphylococcus aureus (MRSA) and other resistant organisms. The improved breadth and performance of BCID2 panel aims at reinforcing Biofire’s leadership in the diagnosis of bloodstream infections. Share this: Related Post GE Announces Completion Of BioPharma Sale
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