By Horvatovich, Peter; Bischoff, Rainer; Thurston, David E; Fox, David; Rotella, David

Content material: advent to biomarker discovery and validation; scientific context of proteomics biomarker discovery and validation, authority laws; Biomarker discovery: sufferer choice; Biomarker discovery: Experimental layout and biobanking; Biomarker discovery: physique fluids; Biomarker discovery: tissues; Biomarker discovery: mass spectrometry established profiling structures; Biomarker discovery: array established profiling systems; Biomarker discovery: information preprocessing for LC-MS information; Biomarker discovery: facts preprocessing for Maldi imaging, and second electrophoresis and protein arrays information; Biomarker discovery: statistical research and validation; Biomarker validation: biomarker validation equipment; sensible biomarker validation; medical software: case experiences scientific software: precis and destiny know-how improvement developments

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112 Also, mass-spectrometry methodologies have strongly developed and enabled the analysis of changes in peptide, protein and metabolite isoforms that reflect perturbations of biological systems. 12 This strategy not only increases the chance of identifying candidate biomarkers but it also generates independent data that provides additional mechanistic support of the best biomarker. 121 This progress has dramatically changed the landscape of biomarker discovery and strongly increased the potential of identifying more specific and applicable biomarkers for human medicine.

3 Robust Biomarker Tests To be able to mature to a molecular diagnostic test, candidate biomarkers need to be developed through a rigorous process. 19,125 This lengthy process is aimed to optimize the specificity and selectivity of the diagnostic test, whilst minimizing its cost and demonstrating its usefulness in clinical practice. Whereas great progress has been made in the front end of this diagnostic development pipeline, little progress has been made in the latter part. In particular, major gaps remain in the diagnostic test development and multicenter validation of candidate biomarkers, as this type of work is generally not easily funded by grants.

Although across-the-board funding opportunities have decreased, funding agencies generally prefer to support multicenter consortia rather than single laboratories. Good examples of public–private partnerships that we have recently been involved in include Netherlands programs such as Top Institute Pharma and Center of Translational Molecular Medicine, USA-based Critical Path Initiatives and European framework programs. These partnerships have brought together basic and applied biomarker researchers in academia and industry and have stimulated knowledge transfer and a focus towards applied biomarker research.

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