“We are 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."
Deepak Nath
President, Laboratory Diagnostics
Siemens Healthineers
“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.”
Tania Kamphaus
Director of Metabolic Disorders, FNIH
“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.“
Deepak Nath
President, Laboratory Diagnostics, Siemens Healthineers
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Liver biopsy remains a major barrier in NASH patient management Currently, the way to identify NASH early is costly and invasive liver biopsy that requires a specialist, may not be representative of the amount of fibrosis, and carries a risk of life-threatening complications.
Liver biopsies remain a major barrier for clinical trial enrollment and the uptake of any NASH drugs in development.
As the prevalence of NASH continues to increase, the use of non-invasive biomarkers will be key in order to identify at risk individuals and improve patient care by reducing the need for biopsy.
- NIMBLE is the FNIH’s largest biomarker consortium. It is a five-year collaborative effort to qualify biomarkers to identify non-alcoholic steatohepatitis (NASH).
- NIMBLE selected biomarkers, (i.e., serum/plasma-based, imaging-based, or a combination) to compare performance against liver biopsy and the ability to measure treatment responses.
- 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.
Siemens Healthineers 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.
- View the abstract here