bioMérieux submits enhanced BIOFIRE® BCID2 panel for FDA clearance

bioMérieux, a world player in the field of in vitro diagnostics, announces 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 BIOFIRE® BCID2 Panel includes several additional pathogens, an expanded list of antimicrobial resistance genes, and many revised targets compared to the existing BIOFIRE® BCID Panel.

Randy Rasmussen, CEO of BioFire Diagnostics and Executive VP Molecular Biology of bioMérieux said: “Rapid identification of bloodstream infections and detection of antimicrobial resistance genes are more important than ever for hospitals and their patients. 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.”

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.

The BIOFIRE® BCID2 Panel is compatible with the FILMARRAY® 2.0 and FILMARRAY® TORCH systems. bioMérieux plans on pursuing BIOFIRE® BCID2 Panel registration in other parts of the world as well.