Scientific expertise

• experienced operations
• data management
• regulatory support
• medical teams
• a NASH network of proven investigators

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.

Liver biopsy - the gold standard
Tissue biopsy diagnosis remains still the gold standard for the assessment of NAFLD and NASH. The staging of the most critical component of NASH —fibrosis— is still best done at the microscope with the help of hematoxylin and eosin (H&E) and two special histochemical stains, Masson’s trichrome and a reticulin (silver) stain. Both stains are validated at our laboratories worldwide. Most patients in a clinical trial have an outside diagnosis and staging of NASH. Due to inter-observer variability, the archival tissues often need to be re-evaluated at the central lab to confirm that outside diagnosis. We have several liver-specialized pathologists who have reviewed tens of thousands of NASH cases over the last five years.

Non-invasive biomarkers for NASH

• 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.
• 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.

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