E.g., 01/28/2020
E.g., 01/28/2020

bioMérieux submits enhanced BIOFIRE® BCID2 Panel for FDA clearance

14 January, 2020

bioMérieux, a world leader 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.d about 9,800.

bioMérieux reinforces its offering of High Medical Value immunoassay biomarkers with the acquisition of Astute Medical

05 April, 2018

Marcy l’Étoile, France – April 4th, 2018 – bioMérieux, a world leader in the field of in vitro diagnostics, announces today the acquisition of Astute Medical Inc., a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers. In particular, Astute developed the NEPHROCHECK® test, an FDA-cleared test for the early risk assessment of acute kidney injuries (AKI) based on the level of two biomarkers, IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7) and TIMP-2 (Tissue Inhibitor Metalloproteinases-2).

Pioneering diagnostics