Abstract
With the proliferation of high-content profiling technologies available for analyzing genetic, transcriptomic, proteomic and metabolomic markers in tissues, both novel analytes and increasingly complex signatures are emerging as biomarkers supporting drug development. If prospective studies during the course of clinical development support the clinical utility of a biomarker, consideration may eventually be given to converting such research-use only biomarker assays into medical diagnostics. The present report briefly summarizes a selected set of presentations geared towards the issues and principles involved in the validation of biomarkers for use as molecular diagnostics, as presented at the Third Annual Biomarker World Congress held in Philadelphia, Pennsylvania on 15 – 18 May 2007. More than 400 delegates attended the Third Annual Biomarker World Congress to discuss the role of biomarkers in all phases of drug discovery and development. The main conference consisted of four tracks addressing issues involving: i) biomarkers in early drug development; ii) biomarkers in clinical development; iii) biomarkers for molecular diagnostics; and iv) biomarker assay development. The present review focuses on selected presentations of relevance to the third track. Topics covered by the speakers included biomarker assays that seem to have diagnostic and/or theranostic potential in a variety of therapeutic settings and disease indications. Themes included both the general and specific issues that can be encountered when attempting to convert a biomarker assay into a molecular diagnostic for use in the clinical setting.
Conflicts of interest
The author owns stock in Wyeth Research.