A collaborative study published in the Journal of Hepatology highlights the potential of artificial intelligence (AI) in revolutionizing the evaluation of liver fibrosis in metabolic dysfunction-associated steatohepatitis (MASH). The study, a joint effort between HistoIndex, Merck & Co. (MSD), Virginia Commonwealth University (VCU), The National Institutes of Health (NIH), and international liver pathologists, demonstrates how AI can bridge clinical research and clinical care by aiding pathologists in the assessment of MASH.
MASH, often associated with obesity and type 2 diabetes, leads to liver inflammation and fibrosis. Accurate fibrosis staging is critical for MASH diagnosis and treatment decisions. The study addresses the challenge of variability in fibrosis staging by showing that HistoIndex's AI digital pathology platform improves the reliability of clinical trial outcomes through a more objective evaluation of fibrosis.
AI Enhances Inter-Pathologist Agreement
The study analyzed 120 digitized histology slides from two Phase 2b MASH clinical trials (NCT03517540, NCT03912532). Results indicated that AI assistance significantly improved inter-pathologist agreement on fibrosis staging, particularly in early-stage fibrosis (F0-F2). HistoIndex's stain-free digital pathology platform, utilizing Second Harmonic Generation/Two Photon Excitation Fluorescence (SHG/TPEF), offered a more consistent, accurate, and detailed assessment of fibrosis severity across the disease spectrum compared to traditional methods. This addresses the long-standing issue of intra- and inter-pathologist variability in MASH biopsy evaluation.
Expert Opinions
"I am excited about the findings of this study, which highlight how AI-assisted SHG/TPEF imaging and quantitative fibrosis scoring have improved inter-pathologist agreement, especially for early-stage fibrosis (F0-F2)," said Dr. Arun Sanyal, M.D., Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine, and Principal Investigator of the study. "This increased accuracy not only enhances confidence in staging but also has the potential to streamline clinical trial processes and reduce the need for third-pathologist adjudication."
Dr. Gideon Ho, CEO of HistoIndex, added, "The findings, especially the improvement in inter-pathologist agreement with AI-assistance, are set to transform both clinical trial assessments that transcend into precise and personalized care for MASH patients."
Implications for MASH Management
This study represents a significant advancement in using AI to support pathologists in MASH clinical trials and routine patient care. It offers a promising approach to improve the consistency and accuracy of MASH diagnosis and management, addressing a significant global health challenge.
About MASH
Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive form of Metabolic dysfunction-associated steatotic liver disease (MASLD) characterized by steatosis and inflammation, which can lead to fibrosis (scarring), cirrhosis, liver failure, and an increased risk of liver cancer. Pathologist assessments of liver biopsy remain the gold standard for diagnosing and assessing the severity of MASH. Histological categorial scoring systems are often used as surrogate endpoints to evaluate drug efficacy in clinical trials. These endpoints are limited in capturing the complex and heterogeneous nature of the disease. As a result, there is a growing need for more accurate and reliable tools, such as AI-based digital pathology solutions, to improve the assessment of treatment response and disease severity in MASH.
