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).
BioFire Diagnostics receives a de novo clearance by the FDA for the FilmArray® Meningitis/Encephalitis panel continuing its extremely favorable business momentum
FilmArray® expanded menu, with a fourth panel, is the largest available on a molecular biology multiplex platform
Marcy l’Etoile (France) - October 27, 2014 - BioFire Defense, LLC of Salt Lake City, UT announced today that it has received Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for its commercial FilmArray® Ebola test (BioThreat-E test™).