Biobanking for Biomarker Discovery

The implementation of personalized or precision medicine involves developing therapeutic agents to fit a patient’s molecular profile. Biomarkers are defined as “any characteristic that can be objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological response to a therapeutic intervention.” Biomarkers typically undergo discovery and development phases. In biomarker discovery or development, the laboratory assays for the markers must be standardized in a way that results are comparable among a variety of laboratories. The importance of a standardized, well-controlled approach to biospecimen management and biobank operation to biomarker discovery is also well-established. A multitude of factors including preanalytical variables can affect biospecimen quality and as a result the analyses necessary to discover and validate biomarkers. Biospecimens of consistent quality are necessary as critical starting materials for biomarker discovery and the clinical assay development processes. Biobanks that serve as sources of biospecimens for biomarker studies should adhere to best practices such as those developed by international biobanking organizations. The importance of biobanking standards in biomarker discovery and development has also been recognized in several sets of recommendations and guidelines for authors, reviewers, and editors.