Molecular Biomarkers for Precision Medicine: Discovery, Validation, and Clinical Translation

Molecular biomarker research is transforming precision medicine by enabling earlier diagnosis, patient stratification, disease monitoring, and treatment selection across diverse diseases. Advances in genomics, transcriptomics, proteomics, metabolomics, epigenomics, single-cell and spatial profiling, liquid biopsy, digital pathology, and clinical data integration have expanded opportunities to identify biologically informative signatures. However, many candidate biomarkers remain confined to small discovery cohorts and fail to achieve clinical use because of inadequate validation, limited reproducibility, population and dataset heterogeneity, uncertain biological interpretation, analytical variability, and inconsistent reporting. Although computational and data-integration approaches are improving candidate prioritization, important questions remain regarding generalizability, clinical utility, biological relevance, and the evidence required for regulatory and healthcare adoption. A coordinated investigation spanning discovery, assay development, validation, and implementation is therefore needed.This Research Topic aims to advance the development of robust and clinically meaningful molecular biomarkers across cancer, cardiovascular, neurological, metabolic, infectious, inflammatory, rare, and other complex diseases. It will examine how molecular measurements can be linked to well-defined clinical questions and translated into reliable tools for early detection, molecular subtyping, risk stratification, disease monitoring, treatment-response prediction, drug-target identification, companion diagnostics, minimal residual disease assessment, and longitudinal follow-up. Contributions should address rigorous study design, transparent and reproducible analysis, appropriate control of bias and uncertainty, and validation in independent, external, prospective, real-world, or experimental settings. The Research Topic will promote dialogue among molecular biologists, clinicians, laboratory scientists, bioinformaticians, statisticians, and data scientists to identify practical pathways from biomarker discovery to precision diagnostics and therapeutics.To gather further insights in molecular biomarker discovery and translation across diseases and clinical applications, we welcome articles addressing, but not limited to, the following themes:• Discovery and validation of DNA, RNA, protein, metabolite, epigenetic, microbiome, extracellular-vesicle, and circulating biomarkers• Single-cell, spatial, and multi-omics approaches to biomarker development\n- Liquid biopsy, molecular assay development, analytical performance, and clinical laboratory implementation• Molecular subtyping, therapeutic-target discovery, pharmacogenomics, and companion diagnostics• Biomarkers for early detection, prognosis, treatment response, minimal residual disease, and disease monitoring• Internal, external, prospective, experimental, real-world, and clinical validation\n- Reproducibility, harmonization, reporting standards, bias, uncertainty, and clinical utility• Integration of molecular, pathology, imaging, and longitudinal clinical data\n- Statistical learning, bioinformatics, machine learning, and artificial intelligence with independent or experimental validationAppendix: We welcome Original Research, Brief Research Reports, Methods, Reviews, Mini Reviews, Perspectives, FAIR² Data, and Technology and Code articles. Topic editors: Wentai Zhang, Yu Guo, Jin-Dong Xie, Cankun Wang, Xiaoxu Li Source: https://www.frontiersin.org/research-topics/85710/molecular-biomarkers-for-precision-medicine-discovery-validation-and-clinical-translation