Biomarkers in the Context of Health Authorities and Consortia

Abstract While multiple publications have described the use of biomarkers for personalized medicine in early stages, only limited numbers of biomarkers have progressed to use in patient care, owing to limitations in the scientific evidence, the development resources required, and regulatory hurdles. This chapter highlights the development pathway and regulatory requirements to bring biomarkers as in vitro diagnostic tests and as companion diagnostic tests to the market. Further, collaborations of stakeholders in consortia to qualify biomarkers as drug development tools will be highlighted.