FNIH Biomarkers Consortium Launches NIMBLE to Replace Invasive and Painful Biopsy with Non-Invasive Biomarkers for Liver Disease

June 11, 2019 – The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium has launched a new project under its Metabolic Disorders Steering Committee that will standardize biological markers (biomarkers) that help diagnose Non-Alcoholic SteatoHepatitis (NASH) – a type of liver disease. The “Non-Invasive Biomarkers of Metabolic Liver DiseasE (NIMBLE)” project will directly compare imaging and blood-based biomarkers to biopsy results to define the best tools for diagnosing NASH. This information will help physicians identify patients who are most likely to progress to serious complications, such as liver failure or cancer.

Up to 16.5 million people in the United States are living with NASH, and its prevalence continues to increase**. NASH is associated with obesity and diabetes and is characterized by fat and fibrous build up in the liver. Unfortunately, NASH does not present any symptoms until it progresses to later stages, when serious complications like cirrhosis leave few options for patients. If left untreated, it can lead to permanent liver damage, which ultimately requires a liver transplant to prevent cancer or death.

Liver biopsy is currently the only way to definitively diagnose a patient with NASH, but it is extremely invasive, painful and can lead to complications. The NIMBLE project team will analyze many promising non-invasive biomarkers and compare them with each other and against liver biopsies with the goal of identifying an accurate and widely-deployable non-invasive marker to make diagnosis easier. They will assess and validate the most promising biomarkers and share the results with the broader research community through peer-reviewed publications. In addition, the biomarkers will be submitted for qualification under the U.S. Food and Drug Administration (FDA) Biomarkers Qualification Program so that all drug development efforts in the area can be guided by a consistent set of non-invasive biomarker diagnostic approaches. The development of patient-friendly and standardized approaches for diagnosis and monitoring of NASH is an essential goal for the research community that will help patients with this deadly and invisible disease.

The project team includes experts from the FNIH, FDA, academia, as well as the diagnostic, device and pharmaceutical industries. For more information about the project, click here.

Public Partners

  • U.S. Food and Drug Administration

Private Partners

  • Allergan*
  • AstraZeneca*
  • Boehringer Ingelheim*
  • Bristol-Myers Squibb*
  • Echosens SA*
  • GE Healthcare*
  • Genentech, a member of the Roche Group*
  • Gilead Sciences, Inc.*
  • Intercept Pharmaceuticals, Inc.*
  • Novo Nordisk*
  • Pfizer*
  • Takeda Pharmaceuticals Company Limited*

Academic Partners

  • Massachusetts General Hospital, an affiliated teaching hospital of Harvard Medical School
  • University of California San Diego School of Medicine
  • Virginia Commonwealth University

*provides financial or in-kind support for this program.

Read what project partners are saying.

**Estes, Chris F et al. “Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease.” Hepatology (2018).

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