Foundation Models -- A Panacea for Artificial Intelligence in Pathology?

The role of artificial intelligence (AI) in pathology has evolved from aiding diagnostics to uncovering predictive morphological patterns in whole slide images (WSIs). Recently, foundation models (FMs) leveraging self-supervised pre-training have been widely advocated as a universal solution for diverse downstream tasks. However, open questions remain about their clinical applicability and generalization advantages over end-to-end learning using task-specific (TS) models. Here, we focused on AI with clinical-grade performance for prostate cancer diagnosis and Gleason grading. We present the largest validation of AI for this task, using over 100,000 core needle biopsies from 7,342 patients across 15 sites in 11 countries. We compared two FMs with a fully end-to-end TS model in a multiple instance learning framework. Our findings challenge assumptions that FMs universally outperform TS models. While FMs demonstrated utility in data-scarce scenarios, their performance converged with - and was in some cases surpassed by - TS models when sufficient labeled training data were available. Notably, extensive task-specific training markedly reduced clinically significant misgrading, misdiagnosis of challenging morphologies, and variability across different WSI scanners. Additionally, FMs used up to 35 times more energy than the TS model, raising concerns about their sustainability. Our results underscore that while FMs offer clear advantages for rapid prototyping and research, their role as a universal solution for clinically applicable medical AI remains uncertain. For high-stakes clinical applications, rigorous validation and consideration of task-specific training remain critically important. We advocate for integrating the strengths of FMs and end-to-end learning to achieve robust and resource-efficient AI pathology solutions fit for clinical use.

Physical Color Calibration of Digital Pathology Scanners for Robust Artificial Intelligence Assisted Cancer Diagnosis

The potential of artificial intelligence (AI) in digital pathology is limited by technical inconsistencies in the production of whole slide images (WSIs), leading to degraded AI performance and posing a challenge for widespread clinical application as fine-tuning algorithms for each new site is impractical. Changes in the imaging workflow can also lead to compromised diagnoses and patient safety risks. We evaluated whether physical color calibration of scanners can standardize WSI appearance and enable robust AI performance. We employed a color calibration slide in four different laboratories and evaluated its impact on the performance of an AI system for prostate cancer diagnosis on 1,161 WSIs. Color standardization resulted in consistently improved AI model calibration and significant improvements in Gleason grading performance. The study demonstrates that physical color calibration provides a potential solution to the variation introduced by different scanners, making AI-based cancer diagnostics more reliable and applicable in clinical settings.