PharmaNest Inc. has announced a multi-institutional research collaboration with Virginia Commonwealth University (VCU) and the National Institutes of Health (NIH) to validate the prognostic accuracy of artificial intelligence-powered digital pathology biomarkers in metabolic dysfunction-associated steatotic liver disease (MASLD). The study, known as the Digital Pathology and AI for Liver Outcomes Study - 2 (DPAILO-2, NCT06493253), will analyze a retrospective cohort of 1,765 patients with MASH (NASH CRN DB2 Cohort), using ultra-high-resolution digital pathology images from liver biopsies stained with Masson’s Trichrome. The collaboration brings together leading experts: Professor Arun Sanyal, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at VCU; Dr. David Kleiner, M.D., Ph.D., Principal Investigator of the NIH’s NASH Clinical Research Network (NASH CRN); and Dr. Mathieu Petitjean, Ph.D., CEO of PharmaNest. The study is supported as an ancillary project by the NIH NASH CRN and aims to confirm the clinical utility of PharmaNest’s FibroNest Ph-FCS biomarker—a continuous, AI-driven fibrosis score derived from single-fiber analysis of digital pathology images. The primary objective is to evaluate Ph-FCS’s ability to predict hepatic decompensation over time. Secondary goals include comparing the biomarker’s performance against traditional fibrosis staging systems and non-invasive tests. Exploratory aims will leverage FibroMAP, PharmaNest’s single-fiber clustering technology, to identify novel fibrosis risk phenotypes using paired biopsies from the same patients. VCU will lead study governance, ensure NIH compliance, and conduct statistical analyses. PharmaNest will sponsor the study, process the digital pathology images, and deliver AI-generated biomarkers within the 2025 timeline. The NIH’s NASH CRN will provide clinical oversight and ensure alignment with network-wide research standards. “This collaboration marks a critical advancement toward establishing reliable histological biomarkers that can guide clinical decision-making and accelerate drug development in MASLD,” said Professor Arun Sanyal. “By combining the NASH CRN’s deep clinical expertise with PharmaNest’s AI-driven single-fiber pathology tools, we aim to deliver precise, quantitative assessments of fibrosis progression and treatment response—offering hepatologists and patients more accurate, actionable insights.” Dr. David Kleiner added, “The integration of advanced digital pathology with AI holds immense promise for improving outcomes in liver disease. This study will rigorously test the predictive power of these new tools in a large, well-characterized patient cohort, helping to define the future of liver disease monitoring.” Dr. Mathieu Petitjean emphasized, “PharmaNest is proud to apply our FibroNest™ platform to this landmark study. The Ph-FCS biomarker has already demonstrated strong prognostic performance in over 400 patients with more than a decade of follow-up. This large-scale validation effort will further solidify its potential as a regulatory-grade digital biomarker and unlock new scientific discoveries through our FibroMAP™ spatial histology tools.” The Stravitz-Sanyal Institute at VCU is committed to advancing research, clinical care, and education in liver and metabolic diseases through innovation and collaboration. The NASH CRN is a federally funded network dedicated to accelerating research in nonalcoholic fatty liver disease and steatohepatitis. PharmaNest Inc. is a digital pathology company pioneering AI-based single-fiber analysis for fibrosis and inflammation in both preclinical and clinical settings.