ABSTRACT
Discovering a biomarker is just the beginning of a process. Next, this biomarker needs to be tested in preclinical and clinical trial samples to define its utility. In order to do so, one must first develop a robust method for testing the biomarker. This section deals with the different ways of characterizing biomarkers and puts them in their utility context. An overview of the different biomarker types is given, using the FDA guidelines, followed by the technical characteristics needed to use the biomarkers in the different contexts. The idea is to present a summarized view of such characteristics to provide the outline needed for each purpose. Then, the application of the different characteristics is left to the user to fully be able to develop the right fit-for-purpose validation for their biomarkers.
