From Biomarker Discovery to Targeted Clinical Application: Addressing Translational Gaps in Early Cancer Detection.

Despite extensive progress in breast cancer biomarker research, only a limited proportion of candidate biomarkers successfully transition from early discovery to clinically validated tools for targeted early detection. This article examines the key translational barriers that impede this progression across the biomarker development continuum. Five major gaps are identified: (i) discovery-to-clinical relevance, (ii) methodological and analytical validation, (iii) regulatory and administrative complexity, (iv) translational performance and real-world integration, and (v) equity and deployment challenges. Collectively, these gaps highlight limitations not only in scientific and methodological rigor but also in validation frameworks, regulatory alignment, implementation feasibility, and healthcare system equity. This article emphasizes that successful biomarker translation requires more than analytical validity. Finally, it requires a supportive ecosystem that enables effective breast cancer early detection strategies and improves population-level outcomes in breast cancer care.