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NASH and Liver Disease Drug Development

Nonalcoholic Fatty Liver Disease & Non-alcoholic Steatohepatitis (NAFLD & NASH)

Nonalcoholic Fatty Liver Disease (NAFLD) is a chronic liver disease, affecting patients across the globe. NAFLD ranges from simple steatosis to necroinflammation, fibrosis and cirrhosis. There are two types of NAFLD, and about 20% of patients with NAFLD are estimated to progress to Non-alcoholic steatohepatitis (NASH). Patients with NASH often develop more serious liver conditions, such as fibrosis/cirrhosis of the liver and hepatocellular carcinoma (HCC). Our expert team integrates therapeutic insights, state-of-the-art technologies, best-in-class methods and quality systems to optimize your NAFLD/NASH study design, ensuring high-quality data delivery and regulatory approval.

Scientific expertise

Our scientific experts include pathologists and scientific advisors in liver disease, infectious disease, and translational genomics. We have participated in more than 25 hepatology studies in various capacities, and we provide custom product-specific assay support. Through collaboration with our parent organizations, we have a cross-company NASH and NAFLD team with solid experience, global CRO expertise, and multiple reference testing services. This Center of Excellence (CoE) in NASH includes:
  • experienced operations
  • data management
  • regulatory support
  • medical teams
  • a NASH network of proven investigators

Innovations in patient identification using proprietary algorithms and data resources assure the completion of a NASH clinical trial on time and within budget.

Experience

We offer an extensive test menu of liver function tests – both standard and custom tests - and the strategic guidance to address your study goals to ensure better outcomes and regulatory approvals.
  • We have several composite biomarker tests to evaluate for NAFLD/NASH.
  • Genetic factors may play an important role in determining the phenotypic manifestation and overall risk for NAFLD. We perform the testing for these genetic markers, and for the miRNAs which are upregulated in NAFLD.
  • We offer the Enhanced Liver Fibrosis (ELF™) Test, a blood test to assess the risk of NAFLD/NASH progression and liver-related events by measuring three direct markers of fibrosis.

Global capabilities

Our global anatomic pathology services and central laboratory capabilities provide a streamlined operational management structure to ensure continuity and process alignment. We provide the following services to address your testing needs:
  • state-of-the-art technologies
  • quality management systems
  • global capacity
  • high-quality infrastructure
  • project management
  • sample processing
  • long-term sample storage

Contact us for more details on our capabilities and testing services.