The goal of the proposed study is to develop reagents for the optimal handling of pre-analytical biospecimen for use in biomarker discovery and biomedical research. The advent of molecular diagnostics and personalized medicine bears great promise for changing the field of medicine by enabling better and earlier detection of disease, as well as the selection of individualized therapeutic options. This approach requires the discovery, selection and validation of biomarkers that are suitable to detect disease and/or allow selection of treatment options. While biomarker discovery technology has advanced and become readily available, the clinical validation and availability of biomarkers has not evolved at the same pace. Some of the key issues relate to enormous variances in the quality of clinical samples, which can significantly skew discovery, especially in small patient cohorts. What are clearly needed are better methods to ensure reproducible sample collection and stabilization that eliminates sampling induced inconsistencies. This proposal is therefore directed to perform comparative studies that will define the optimum conditions for preserving the structural and functional properties of tissues, cells and body fluids from the specimen.
