Abstract
Immunohistochemistry (IHC) is essential for diagnostic, prognostic, and predictive biomarker assessment in oncology, but manual interpretation is limited by subjectivity and inter-observer variability. Machine learning (ML), a computational subset of AI that allows algorithms to recognise patterns and learn from annotated datasets to make predictions or decisions, has led to advancements in digital pathology by supporting automated quantification of biomarker expression on whole-slide images (WSIs). This review evaluates the role of ML-assisted IHC scoring in the transition from validated biomarkers to the discovery of emerging prognostic and predictive IHC biomarkers for genitourinary (GU) tumours. Current applications include ML-based scoring of routinely used biomarkers such as ER/PR, HER2, mismatch repair (MMR) proteins, PD-L1, and Ki-67, demonstrating improved consistency and scalability. Emerging studies in GU cancers show that algorithms can quantify markers including androgen receptor (AR), PTEN, cytokeratins, Uroplakin II, Nectin-4 and immune checkpoint proteins, with early evidence indicating associations between ML-derived metrics and clinical outcomes. Important limitations remain, including limited availability of training datasets, variability in staining protocols, and regulatory challenges. Overall, ML-assisted IHC scoring is a reproducible and evolving approach that may support biomarker discovery and enhance precision GU oncology.