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.

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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