Tumour markers and evidence-based pathology

BackgroundTumour biomarkers have become increasingly important in oncology, shaping cancer diagnostics, classification, and patient management. Despite their potential, the use of cancer biomarkers in clinical settings remains limited.ObjectiveThis paper aims to outline biomarker development, from classical, serum protein markers to emerging tumour biomarkers, including meta-biomarkers, to show their diversity and point out the challenges in their development, reporting, and implementation in clinical practice as well as their relevance in evidence-based pathology and cancer classification.MethodsA literature-based analysis, incorporating insights from our ongoing research, is presented.ResultsAlthough numerous potential biomarkers, biomarker signatures, and meta-biomarkers, are being discovered, existing innovations are often not supported by sufficiently rigorous research methodologies and standardised reporting practices to enable their translation into clinical practice.ConclusionsTo ensure that biomarker discoveries are both scientifically sound and clinically useful, improved research and validation methods, along with adherence to established reporting standards, are essential. We propose the use of the Hierarchy of Evidence for Tumour Pathology as a framework to evaluate and map existing evidence and identify knowledge gaps and research priorities.