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AI-Driven Multiomics Biomarkers for Precision Oncology: Navigating the Translational Gap and Regulatory Hurdles
Ujwal Havelikar1,2, Atharv Shinde2, Hrushikesh Mhaismale2
1Department of Pharmaceutics, Chitkara College of Pharmacy, Chitkara University, Rajpura, India.
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.
Insights
Precision oncology leverages multiomics and AI for personalized therapies. This review outlines a roadmap for developing reliable, multiomics-driven biomarkers to overcome clinical translation challenges.
Area of Science:
- Integrative oncology
- Biomarker discovery
- Artificial intelligence in medicine
Background:
- Precision oncology integrates multiomics data (genomics, transcriptomics, proteomics, metabolomics, radiomics) and AI for personalized treatments.
- Clinical translation of multiomics biomarkers faces challenges including heterogeneity, validation, bias, and regulatory hurdles.
Purpose of the Study:
- To critically evaluate how integrated advanced technologies facilitate precision oncology.
- To provide an integrative roadmap for multiomics-driven biomarker approaches in precision oncology practice.
Main Methods:
- Literature search of PubMed, Web of Science, and Scopus (2020-2025).
- Analysis of multiomics data generation, integration, biomarker discovery, validation, and regulatory implementation.
- Examination of computational approaches (machine learning, deep learning, graph neural networks) and ethical considerations.
Main Results:
- Advanced technologies support various omics fields for precision oncology.
- A five-stage framework addresses biomarker identification and clinical applications.
- Emerging computational approaches and regulatory frameworks are crucial for biomarker development.
Conclusions:
- Standardized, validated, and transparent learning strategies are essential for reliable clinical standards.
- An integrated roadmap is provided for modern multiomics biomarker approaches in precision oncology.
- Overcoming translation barriers requires addressing reproducibility and validation issues.
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