Siemens Healthineers was recognized in Stage I of the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) study. The data from “LO1: Primary Results of the NIMBLE Stage 1-NASH CRN Study of Circulating Biomarkers for Nonalcoholic Steatohepatitis and its Activity and Fibrosis Stage,” presented in a late-breaking oral presentation at The Liver Meeting 2021, show that Siemens Healthineer’s ELF Test performed the best of the five blood biomarkers selected for the study. The ELF Test was one of three biomarkers in the study that met the criteria for the successful identification of fibrosis stage ≥2. The performance of the ELF Test further improved for fibrosis stage ≥3 and stage 4, according to the company
“Siemens Healthineers is proud the ELF Test was recognized as a top-performing biomarker, with potential to reshape the way NASH clinical trials are performed. We know that liver biopsies remain a major barrier for clinical trial enrollment. The study results are encouraging and demonstrate that non-invasive biomarkers provide the potential to improve the way in which we identify NASH, and evaluate treatment efficacy,“ says Deepak Nath PhD, president, Laboratory Diagnostics, Siemens Healthineers, a member of NIMBLE. “We are at the first step to revolutionizing clinical trials in NASH, and look forward to our continued collaboration with NIMBLE in the pursuit of regulatory qualification.“
NIMBLE, the largest biomarker consortium from the FNIH, aims to revolutionize the ability to qualify non-invasive biomarkers to easily identify NASH, a serious condition associated with obesity and diabetes, affecting about 15 million people in the United States. If successfully qualified by regulatory authorities, the selected NASH biomarkers will be used in clinical trials to develop therapies to treat NASH, as well as to identify NASH and assess patients’ responses to treatment. The FDA accepted NIMBLE’s Biomarker Qualification Letter of Intent in May 2020.
“The results of this Stage 1 study represent a significant milestone for the NIMBLE initiative getting us closer to a better, less invasive way to conduct clinical research by reducing the need for biopsy,” says Tania Kamphaus, director of Metabolic Disorders, Foundation for the NIH.
Siemens Healthineers says it will continue to collaborate with FNIH and NIMBLE on the next stage of studies as the organizations work to pioneer new tools to evaluate NASH.
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