AI-Driven Multiomics Biomarkers for Precision Oncology: Navigating the Translational Gap and Regulatory Hurdles.

Abstract

The discussion on precision oncology integrates multiomics technologies and artificial intelligence, specifically addressing biomarker discovery and personalized therapeutic strategies. In this way, clinical translation and multiomics biomarkers are reconstructed challenges such as heterogeneity, validate, algorithmic bias, regulatory complexities, and ethical issues. This review critically evaluates how advanced technologies operating in an integrated manner facilitate precision oncology by supporting fields such as genomics, transcriptomics, proteomics, metabolomics, and radiomics. To conduct the study, we performed literature search using standard databases such as PubMed, Web of Science, and Scopus, focusing on papers published between 2020 and 2025. We address the all aspects of biomarker identification and clinical applications; we employed a five-stage framework comprising multiparametric data generation, integration, biomarker discovery, rigorous validation, and regulatory implementation. To further examine this review, we have employed emerging computational approaches, including machine learning and deep learning and graph neural networks alongside regulatory frameworks and ethical, legal, and social considerations. Discussing translation barriers, we consider factors such as limited reproducibility, validation, and critical discussion particularly studies. Ultimately, a future model based on standardized, validated, and transparent learning strategies accelerates and fosters the development of clinically reliable standards. Our review provides an integrative roadmap for modern, multiomics-driven biomarker approaches in precision oncology practice.