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.
News24 March, 2020
bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its subsidiary, BioFire Defense, has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE® COVID-19 test for use in CLIA moderate and high complexity clinical...
bioMérieux reinforces its offering of High Medical Value immunoassay biomarkers with the acquisition of Astute Medical
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).