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BioMérieux Submits 43-Target BCID2 Test to FDA

NEW YORK – BioMérieux announced Tuesday that its BioFire Diagnostics subsidiary has submitted an enhanced version of its blood culture identification (BCID) assay to the US Food and Drug Administration for 510(k) clearance. The new panel, called BCID2, includes revised targets and additional pathogens and resistance genes.

The BCID2 targets 43 bacteria, yeast, and resistance genes in a single multiplexed PCR test. Specifically, it detects and differentiates 26 bacteria, seven yeasts, and 10 antimicrobial resistance genes. The test incudes emerging pathogens, like Candida auris, and improved targeting of resistant organisms, like methicillin-resistant Staphylococcus aureus, the firm said in a statement.

The original BCID test was cleared by the FDA in 2013, and detects 26 targets; 18 bacteria, five fungi targets, and three resistance markers.

"Our expanded panel and syndromic approach means that a single, comprehensive test will allow for the detection of the most common clinically relevant pathogens and their resistance profile, enabling more targeted, effective treatment," said Randy Rasmussen, CEO of BioFire Diagnostics and executive VP of molecular biology of BioMérieux.

The test runs on the BioFire FilmArray 2.0 and FilmArray Torch systems, which reached 9,800 placements globally as of September 30, 2019, the firm said.

According to the firm's website, the additional 17 targets in the BCID2 include: Bacteroides fragilis, Klebsiella aerogenes, Salmonella, Stenotrophomonas maltophilia, Enterococcus faecalis, Enterococcus faecium, Staphylococcus epidermidis, Staphylococcus lugdunensis, Candida auris, Cryptococcus neoformans/gattii, and the resistance-conferring genes IMP, OXA-48-like, NDM, VIM, mcr-1, CTX-M, and a combined target of mecA/C and MREJ.