Regulation of biomarker analysis: what can Be translated in the clinic?

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Review highlights regulatory frameworks for biomarker use in clinical practice, suggesting AI may enhance validation.

Biomarkers play a crucial role in precision medicine, improving diagnosis and guiding treatment decisions.
The review identifies key regulatory frameworks that facilitate the transition of biomarkers from research to clinical settings.
Challenges in biomarker translation include technical and ethical issues, alongside the need for rigorous validation processes.
Future advancements may involve AI and multi-omics approaches, demanding global collaboration among regulatory bodies and stakeholders.

Diamantopoulos et al. (2025) studied this question.

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