Hence, the challenge is to include the development of stratification biomarkers into the concept of disease prevention and drug development. In addition, we should distinguish between biomarkers and assays. Biomarkers need to be qualified and properly detected before they can be used in the clinics. Therefore, the applicability of a qualified biomarker relies also on the development of a robust assay. Consequently, the development chain including the discovery of the stratification biomarker, the development of the assay and the qualification of the marker should preferably start in the preclinical phase and the selected stratification biomarkers be explored in clinical.
