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Nimble technologies8/28/2023 The NIMBLE project is supported by multiple entities including AbbVie, Amgen Inc., AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Echosens, GE Healthcare, Genentech, Inc., Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Novo Nordisk A/S, Pfizer Inc, Regeneron Pharmaceuticals Inc, and Takeda Development Center Americas Inc. The NIMBLE consortium is a comprehensive multi-year pre-competitive, public-private partnership collaboration conducted under the auspices of the Foundation for the NIH (FNIH) Biomarkers Consortium. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization. The FNIH organizes and administers research projects supports education and training of new researchers organizes educational events and symposia and administers a series of funds supporting a wide range of health issues. The Foundation, also known as the FNIH, works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. The Foundation for the National Institutes of Health (FNIH) creates and manages alliances with public and private Institutions in support of the mission of the NIH, the world’s premier medical research agency. Moreover, they will hopefully pave the way for regulatory qualification for non-invasive tests in NASH. And w ith NIS4® technology already powering a commercially available test in the US and Canada as a Laboratory Developed Test, we believe that these findings will have a strong utility for the whole NASH field and for all practitioners. Th is FNIH study is a critical milestone for us as it confirms our previous findings. Pascal Prigent, CEO of GENFIT, added: “ NIS4 ® technology was conceived and developed to identify at-risk NASH, and we are thrilled today to see that its performance and utility ha ve been recognized by a large biomarker consortium of well-respected experts using an independent approach and a robust methodology. NIMBLE’s initial data results offer a potential path for companies developing new therapies for NASH to enrich clinical trial populations and accelerate drug development. It has important implications for the evolving standard of care for patients and for drug development. The presentation concluded that NIS4® technology met the a priori criteria established for Stage 1 NIMBLE by the NIMBLE Circulating Biomarkers Workstream (CWS) for:Īrun J Sanyal, MD, FAASLD, stated: “ The ability to rigorously diagnose at-risk NASH with non-invasive tests is critical to preventing disease progression before it becomes too late for patients. The study also provided evidence that NIS4® technology – with a sensitivity of 82.3 and a specificity of 79.9 – had the best results for the diagnosis of fibrosis stage ≥ 2, a critical component of “at-risk” NASH. Of the five blood-based biomarker panels which were assessed in this study, only NIS4® technology produced results showing the capacity to identify these “at-risk” NASH patients. The late-breaking oral presentation “LO1: PRIMARY RESULTS OF THE NIMBLE STAGE 1-NASH CRN STUDY OF CIRCULATING BIOMARKERS FOR NONALCOHOLIC STEATOHEPATITIS AND ITS ACTIVITY AND FIBROSIS STAGE” at The Liver Meeting 2021 highlighted the importance for the diagnosis of “at risk” NASH patients (defined as NASH + NAS ≥4 and fibrosis ≥2) as a subpopulation at greater risk of liver-related outcomes. Lille, France Cambridge, M A November 18, 2021 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, is proud to announce that NIS4® technology’s utility has been recognized in a Stage 1 study 1 undertaken by the Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) initiative of the Foundation for the National Institutes of Health’s Biomarkers Consortium as demonstrating a unique performance in identifying patients with “at-risk” Non-Alcoholic Steatohepatitis (NASH). GENFIT: FNIH NIMBLE Study Demonstrates NIS4® Technology’s Unique Performance in…
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