Non-Oncology Biomarkers in Precision Medicine: A Narrative Review.

Precision medicine has revolutionized oncology by leveraging biomarkers for individualized therapy selection, early diagnosis, and real-time disease monitoring. However, the application of biomarkers in non-oncology therapeutic areas remains comparatively underdeveloped despite significant potential. This narrative review explores the evolving role of biomarkers across cardiovascular, renal, neurological, metabolic, and respiratory diseases, focusing on their clinical and regulatory contexts of use-diagnostic, prognostic, predictive, surrogate, safety, and pharmacodynamic/response. Key examples include high-sensitivity troponins and natriuretic peptides in cardiology, NGAL and KIM-1 in nephrology, NfL in neurology, and HbA1c in diabetes, each illustrating how molecular markers improve disease characterization, guided therapy, and accelerate clinical development. By integrating multi-omics technologies, artificial intelligence, and standardized validation frameworks, the field is poised to extend the benefits of precision medicine well beyond oncology. Ultimately, establishing robust biomarker infrastructures across non-cancer domains will enhance patient stratification, optimize drug development efficiency, and enable personalized therapeutic strategies across a broad spectrum of chronic diseases.