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BioMérieux Gets Health Canada Approval for Updated BioFire Blood Culture ID Panel

NEW YORK – BioMérieux announced on Tuesday that it has received Health Canada approval for the BioFire Blood Culture Identification 2 panel for rapid identification of bloodstream infections.

The BCID2 panel includes additional pathogens, an expanded list of antimicrobial resistance genes, and revised targets compared to the original BCID panel, the firm said in a statement.

From a positive blood culture sample, the panel detects 43 targets associated with bloodstream infections, including gram-negative bacteria, gram-positive bacteria, yeast, and 10 antimicrobial resistance genes, with results available in about one hour.

"The BioFire BCID2 panel empowers small and large laboratories across Canada to shorten time to pathogen identification by up to 70 percent and to the optimal therapy initiation by 33.5 hours," said Jessica Blavignac, director of scientific and medical affairs at BioMérieux Canada.

BioMérieux submitted the BCID2 to the US Food and Drug Administration in 2020, and the quality control material for the test, which is manufactured by Streck, received US FDA clearance in January of 2022. The firm also received de novo authorization from the US FDA for a 39-target joint infection panel earlier this month.