1/25/2024 0 Comments Biofire diagnosticsThey are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.īioMérieux is listed on the NYSE Euronext Paris stock marketĬorporate website: - Investors website: 1. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. In 2014, revenues reached €1,698 million with 88% of sales outside of France.īioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. FilmArray ® has the largest infectious disease pathogen menu commercially available: it currently comprises 3 other panels – upper respiratory, blood culture identification and gastrointestinal – all of which are FDA-cleared and CE-marked.Ī world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors. next month, followed by CE-marking shortly after.įilmArray ® is a FDA-cleared and CE-marked multiplex PCR molecular biology system that is easy to use, accurate and rapid. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in. The ME Panel is cleared for the FilmArray ® and FilmArray ® 2.0 systems and will be commercially available in the U.S. diagnostic medical devices (Regulation (EU) 2017/746). Bacterial meningitis can occur suddenly in healthy people and even with prompt diagnosis and treatment, approximately 10% of patients may die and up to 20% may sustain permanent damage and disability 1. More than 1.2 million people every year are affected by meningitis worldwide, resulting in 120,000 deaths globally from the bacterial meningitis form. It quickly and efficiently provides physicians complex diagnostic information, helping them to rapidly diagnose severe infections.” Rasmussen continues, “the FilmArray ® ME Panel further solidifies our leadership in syndromic infectious disease testing with now four IVD panels launched in four years.” Randy Rasmussen, bioMérieux Corporate Vice President of Molecular Biology and CEO of BioFire Diagnostics, adds: “The ME Panel highlights the clinical impact the FilmArray ® brings to infectious disease testing. "In the United States, current diagnostics are underutilized and not available in a timely manner to alter the empirical treatment for the majority of patients, especially for those who may have viral meningitis and do not benefit from antibiotics.” "BioFire’s ME Panel has the potential to significantly impact patient treatment for cases of suspected meningitis," states Rodrigo Hasbun MD, MPH, Associate Professor of Medicine at the University of Texas Medical School in Houston. At the end of June 2015, the installed base of FilmArray ® systems reached 1,900 instruments and sales more than doubled year-on-year. This clearance occurs in the very favorable context of the adoption of FilmArray ® by clinical laboratories. Currently, testing CSF for multiple organisms is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests. With its unique and highly beneficial medical value, this panel is the first to address the critical unmet need for quick and accurate identification of central nervous system infectious agents by utilizing a comprehensive panel to test cerebrospinal fluid (CSF) for the 14 most common pathogens (6 bacteria, 7 viruses and 1 yeast) responsible for community acquired meningitis or encephalitis in about an hour. Food and Drug Administration (FDA) yesterday, that BioFire Diagnostics, its molecular biology affiliate, has received a de novo clearance from the FDA for the FilmArray ® Meningitis/Encephalitis (ME) Panel. Spencer S.Marcy l’Étoile, France – Octo– bioMérieux, a world leader in the field of in vitro diagnostics, today announced, as issued in a press release by the U.S. History of the Health Sciences Collection, University of UtahĬopyright © 2015, University of Utah, All Rights Reserved Eccles Health Sciences Library, University of Utah BioFire's FilmArray enables rapid molecular testing for dozens of different organisms. Co-founded in 1990 by Randy Rasmussen, PhD, Kirk Ririe, BS, and Ririe's academic mentor, Carl Wittwer, MD, PhD. Biomedical Research Biomedical Technology Technology Transfer Diffusion of Innovation Molecular Diagnostic Techniques Diagnostic Techniques and Procedures Early Diagnosis Communicable Disease Syndrome DetectionīioFire Diagnostics is one of the most successful spinoff companies ever created from technologies developed at the University of Utah.
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