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

Introduction: The introduction of biomarkers in precision medicine is heralding a new era of diagnostic power and personalized patient care. Biomarkers are critical tools for detecting various diseases, guiding treatment decisions, and predicting patient responses, thereby improving outcomes and reducing healthcare costs.

Areas covered: This review examines the regulatory landscape governing biomarker development and utility, focusing on major frameworks established by well-known regulatory agencies. A broad literature review demonstrates how these frameworks extend from research to clinical application. Also, the review article presents the challenges in biomarker translation and valuable recommendations for overcoming these barriers, while it discusses the future trends in biomarker regulation, including the impact of artificial intelligence (AI) and multi-omics approaches in identification and validation of biomarkers.

Expert opinion: One can conclude that future biomarker regulation will employ an adaptive regulatory framework, AI interventions, and high-throughput approaches. These innovations can transform clinical practices and improve patients' life. However, careful regulation, rigorous validation, overcoming technical - ethical challenges and the tightening quality controls of the routine labs remain essential for successful implementation in clinical practice. More global collaboration is needed among regulatory authorities, academia, industry stakeholders and bioanalytical laboratories.