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Helping to Reshape NASH Clinical Trials

ELF Test indicated as top-performing biomarker in NIMBLE study

Siemens Healthineers is proud to be 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 results of the study were recently presented at The Liver Meeting 2021 and showed that the Enhanced Liver Fibrosis (ELF鈩) Test performed the best of the five blood biomarkers selected for the study.

View Abstract:

鈥淲e 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

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The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed.


The above-described study results outline a potential application of the ELF Test for clinical trial use. For routine clinical management of patients, liver biopsy is currently the gold standard for diagnosing NASH and assessing fibrosis. The ELF Test provides prognostic information supplemental to biopsy.


In the U.S., the ELF Test is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH) to assess the likelihood of progression to cirrhosis and liver-related clinical events. The test is not for use in the diagnosis of NASH or for the staging of fibrosis.