PathAI, a leading entity in artificial intelligence (AI) and digital pathology solutions, has announced the launch of its AIM-MASH product on the AISight Image Management System (IMS). This innovative tool is designed to support the analysis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) by utilizing AI-based measurements to enhance the accuracy of Clinical Research Network (CRN) Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Activity Score (MAS) component grades and fibrosis staging. With projections indicating that MASH cases in the US will reach 27 million by 2030, the introduction of AIM-MASH is particularly timely and crucial.
The AIM-MASH AI-based measurement tools have already demonstrated their effectiveness in over 20 presentations and publications by aiding pathologists in clinical trials. Now integrated into the AISight IMS, these tools offer a seamless connection between trial and laboratory settings. The tools have undergone rigorous evaluation through a comprehensive multi-site analytical validation study involving diverse datasets from four different trials. The findings show that AIM-MASH is reliable and effective in assisting pathologists with MASH assessments through highly sensitive and specific reviews, repeatable and reproducible assessments, and increased scoring confidence.
One notable feature of the AIM-MASH model is its validation by multiple pathologists for high specificity and sensitivity in reviewing MASH biopsies. It accurately highlights key areas such as artifact, steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis. Additionally, the algorithm outputs of AIM-MASH have shown higher repeatability and reproducibility compared to manual reads by pathologists, confirming its precision in measuring the CRN scoring system components in liver biopsies from MASH patients.
Furthermore, the AISight digital IMS facilitates global collaboration, allowing expert GI Liver pathologists to review cases regardless of their location. This eliminates the need for time-consuming and costly shipping of glass slides, thereby utilizing the expertise of MASH specialists more efficiently.
The practical application of AI in MASH assessments was further underscored in a recent case study conducted by PathAI Diagnostics (now Ameripath). This study highlighted the synergy between traditional pathology and AI, demonstrating how AI-assisted pathology can enable more precise evaluations of histologic features relevant to MASH, including steatosis, lobular inflammation, and fibrosis.
Andy Beck, MD, PhD, CEO of PathAI, emphasized the significance of AIM-MASH on the AISight IMS platform, stating, "This product is a game-changer for drug development, as it supports pathologists in making high-quality, reproducible MASH assessments. With AIM-MASH on AISight, pathologists can increase their confidence in pathology reads and decision-making, as if they have the world's expert liver pathologists assisting with every slide."
Dr. Arun J Sanyal, Professor and Interim-Chief of the Division of Gastroenterology, Hepatology, and Nutrition at Virginia Commonwealth University, and co-investigator of the AIM-MASH analytical and clinical validation study, added, "The data supports the use of AIM-MASH by pathologists in clinical trials as a method to resolve the accuracy and precision gaps in MASH assessment while guiding pathologists in an efficient evaluation to result in a standardized and reproducible score."
The addition of AIM-MASH to AISight addresses a crucial gap in pathology labs—the lack of a standardized system ensuring consistent, accurate, and reproducible assessments, particularly for challenging conditions like MASH. With AIM-MASH, PathAI aims to empower pathology labs worldwide by providing digital and AI tools that facilitate precise and reproducible assessments at scale, along with workflow optimization.
