A Clinically Validated Foundation Model for Comprehensive Lung Pathology Interpretation
摘要
Pathological assessment guides lung cancer diagnosis, treatment selection, and prognostic evaluation, yet current CPath approaches rely on task-specific models for isolated objectives. Although pan-cancer foundation models offer versatility, they lack subspecialty-level depth and have not been evaluated across clinical workflows or prospectively validated in real-world settings. We introduce PulmoFoundation, a multi-center, prospectively validated, randomized controlled trial (RCT)-evaluated foundation model for comprehensive lung pathology assessment across pre-operative, intra-operative, and post-operative care. Built upon Virchow2 via subspecialty-specific pretraining using ~40,000 diagnostic H&E-stained whole-slide images (WSIs), PulmoFoundation was systematically evaluated on ~26,000 WSIs across 32 clinically relevant tasks. In addition to accurately predicting molecular markers and patient survival, our model achieves clinical-grade performance in core diagnostic tasks across biopsy, frozen section, and surgical resection slides. In a registered prospective study of 1,357 patients across 11 diagnostic tasks, our model achieved an average AUC of 92.3%. Using pre-specified triage thresholds, PulmoFoundation could reduce additional second-review burden for 68.8% of biopsies and 83.0% of frozen sections, and defer 44.5% of IHC stain orders, with PPVs of 1.0, 0.991, and 0.966. Beyond prospective validation, we conducted a crossover RCT with eight pathologists, in which AI assistance improved diagnostic accuracy across 4,928 case-reader pairs (91.7% w/ AI vs. 83.8% w/o AI). AI assistance also reduced median diagnostic time by 19.6%, increased diagnostic confidence by 8.7%, and improved inter-rater agreement from moderate (kappa = 0.56) to substantial (kappa = 0.76). Together, these evaluations support PulmoFoundation as a clinically validated decision-support system for lung pathology.
引用
@article{arxiv.2605.25878,
title = {A Clinically Validated Foundation Model for Comprehensive Lung Pathology Interpretation},
author = {Zhengrui Guo and Zhengyu Zhang and Jiabo Ma and Yihui Wang and Fengtao Zhou and Yingxue Xu and Ling Liang and Chenglong Zhao and Qi Xie and Jinbang Li and Shujing Guo and Fangyi Han and Zhijian Cen and Ziyi Liu and Cheng Jin and Junlin Hou and Zhixuan Chen and Yu Cai and Lijuan Qu and Shifu Chen and Yueping Liu and Zhe Wang and Xiuming Zhang and Muyan Cai and Li Liang and Hao Chen},
journal= {arXiv preprint arXiv:2605.25878},
year = {2026}
}