Study Evidences Superior Technology to Assess NASH During Clinical Trials

Study Evidences Superior Technology to Assess NASH During Clinical Trials

An international team of pathologists and hepatologists from China, Singapore, Europe and America concluded a study successfully testing qFIBS, a novel automated algorithm developed by HistoIndex which successfully distinguished different grades and stages of histological NASH features with a continuous measurement approach.

What was the Study?
Published in Hepatology, the study was initiated to validated qFIBS for the evaluation of four crucial NASH features including 1) fibrosis 2) lobular inflammation 3) hepatocyte ballooning and 4) steatosis with the goal of evidencing a continuous quantitative, automated and accurate assessment of disease severity.

The study investigators included 219 adult non-alcoholic fatty liver disease (NAFLD)/NASH liver biopsy samples from this global collaboration which afforded the team opportunities for the study to demonstrate the potential of qFIBS in assessing all key histopathological characteristics of NASH, not to mention the value of being able to assess across different ethnicities, environmental/nutritional backgrounds, age groups and disease severity.

What was the Study Finding?

The study findings reveal that qFIBS assessments are more useful than current semiquantitative scores to measure NASH activity and quantify patients’ responses to therapeutics used in clinical trials or patient care.

What is qFIBS?

HistoIndex’s digital pathology platform, which is based on Second Harmonic Generation (SGH) and Two-photon Excitation Fluorescence (TPEF) imaging technology to produce high-resolution images of liver biopsies, which are unstained to further eliminated the potential variation caused by staining.

qFIBS is then employed to automatically recognize the key features of NASH in various regions of the Central Vein (CV), Portal Tract (PT), and Perisinusoidal (PS) within the biopsies, before generating a fully quantified and consistent analysis of the images to determine the severity and monitor the changes in fibrosis, lobular inflammation, hepatocyte ballooning and steatosis that are minute yet important.

Based in the study results, it would be deemed essential for hepatologists and pathologists to be equipped with qFIBS, a robust, standardized and full quantitative adjunct tool to facilitate reproducible and precise liver biopsy assessments to monitor changes in liver tissue that are clinically relevant due to therapeutic intervention in NASH clinical trials.

How qFIBS usage Compare to other NASH detection methods?

In contract to existing conventional discrete staging and scoring methods, which are semiquantitative and may incur potential inter-and intra-observer variability, qFIBS is quantified in a continuous- scale to offer the most precise measurement of the relevant NASH features.  

Who is HistoIndex?

HistoIndex is a diagnostic technology venture focused on precision medicine. Founded in 2010, they are a “medtech” spin-off company from the Institute of  Biotechnology and Nanotechnology (IBN), Agency of Science, Technology and Research (A*STAR), Singapore. They focus on the provision of optical medical imaging systems and services to aid pathologists in diagnostics, clinical trials and research studies for the assessment and staging of diseases.

Lead research/Investigators

Professor Wei Lai, Peking University Hepatology Institute at Peking University People’s Hospital

Professor Jason Chang, Head and Senior Consultant, Department of Gastroenterology & Hepatology, Singapore General Hospital

Dr. Stephen Harrison, Medical Director of Pinnacle Clinical Research, President Summit Clinical Research

Call to Action: NASH is a liver inflammation disease can lead to cirrhosis. The global prevalence of it is increasing in line with obesity. China will face a major NASH crisis. For those interested, sign up for TrialSite News Daily Digest—we will keep you updated on NASH clinical pipelines.