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Development and validation of new biomarkers: major opportunities for health-care scientists

Reflecting significant advances in technology and substantial research investment in discovery programmes, thousands of new biomarkers with diagnostic potential have been identified over the last 30 years. However, only a tiny fraction of these – among them CA125, prostate specific antigen (PSA) and troponin – have successfully joined the routine clinical biochemistry repertoire, and often only after considerable delay. Reasons for this were considered at a multidisciplinary ‘Perspectives in Clinical Proteomics’ conference convened in March 2010 under the auspices of the Wellcome Trust. While primarily focusing on biomarkers identified using proteomic technologies, conclusions developed during the conference and subsequent retreat are equally relevant to the introduction of biomarkers identified by other routes. Among issues highlighted were the pressing need for more thorough and systematic evaluation of new biomarkers and the importance of early involvement of healthcare scientists, both of which are briefly considered here. A more detailed report is available as an open access publication with key points summarized here (Table 1). The proceedings of a recent International Federation of Clinical Chemistry and Laboratory Medicine Bergmeyer Conference on the same topic are also relevant.