PathAI Launches Industry-Backed AIM-HI UC Model on GCP-Compliant Platform to Standardize Histological Assessment in Ulcerative Colitis Trials

BOSTON, Sept. 23, 2025 (GLOBE NEWSWIRE) — PathAI, the global leader in AI-powered pathology, today announced the integration of AIM-HI UC¹, an advanced AI model for Ulcerative Colitis (UC) histology endpoint assessment, on to AISight™ Clinical Trials, PathAI’s GCP and GCLP-compliant platform.

AIM-HI UC¹ was developed by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium’s Mucosal Healing in Ulcerative Colitis Project Team, a collaboration uniting eight of the world’s leading biopharmaceutical companies, representatives from the U.S. Food and Drug Administration (FDA), and renowned researchers in UC. This integration marks a significant step toward advancing standardized, AI-driven histological evaluation in clinical trials for Ulcerative Colitis.

AIM-HI UC was developed and evaluated for exploratory or secondary clinical trial endpoint use. The availability of this algorithm on AISight™ Clinical Trials creates a powerful, end-to-end solution for biopharmaceutical clinical trial sponsors, combining industry-leading AI technology with PathAI’s comprehensive histology lab services.

AIM-HI UC is an AI-assist product designed to enhance the pathologist’s reading experience. Using routine, H&E-stained UC biopsies, the algorithm provides pathologists with a highly reproducible, consensus-trained first read, standardizing the assessment of histological disease activity and reducing the well-known variability of manual scoring. A key feature of the tool is its ability to simultaneously generate scores for all three of the main histological scoring systems—the Geboes Score, Robarts Histopathology Index (RHI), and Nancy Histologic Index (NHI)—providing a comprehensive and standardized output from a single read.

“The collaborative development of this algorithm through the FNIH Biomarkers Consortium represents a landmark achievement in standardizing histological endpoints for Ulcerative Colitis,” said Ben Glass, SVP of Product, Research and AI at PathAI. “By co-developing this product with industry partners and integrating into our AISight Clinical Trials platform, we are offering a solution that is not only scientifically robust but also operationally seamless. It pairs directly with our end-to-end histology services at our biopharma lab in Memphis, providing our partners with a single, GCLP-compliant vendor for their complete clinical trial pathology needs.”

The challenges in IBD drug development are often compounded by the subjectivity of histological assessment. Through providing quantitative and reproducible UC histology scores, AIM-HI UC helps de-risk clinical programs and enables more informed decision-making for secondary and exploratory endpoints.

“AI assisted histopathology will be like central reading to endoscopy in clinical trials. It will enhance objectivity and refine reporting. The implications for future practice are substantial,” said Professor Simon Travis of the University of Oxford.

The development and evaluation of the algorithm will be highlighted in a poster presentation at the upcoming United European Gastroenterology (UEG) conference, from October 4-7, 2025.

To learn more about how PathAI is transforming IBD clinical trials, visit https://www.pathai.com/aim-hiuc.

¹AIM-HI UC is for Research Use Only. Not for use in diagnostic procedures.

About PathAI

PathAI is a leading provider of integrated AI and digital pathology solutions dedicated to transforming workflow and operational efficiency in pathology labs worldwide. Through innovative technologies and strategic partnerships, PathAI aims to enhance patient outcomes and drive the future of medical diagnostics. For more information, visit www.pathai.com.

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