Fig. 1

The biomarker development process can be divided into sequential phases, including preanalytical and analytical validation, clinical validation, regulatory approval, and demonstration of clinical utility. This paper focuses on the aspects of the pre-analytical as well as analytical phases of the validation process prior to clinical validation and regulatory approval phases of development. In the pre-analytical phase, pre-analytical quality indicators should be harmonized including sample collection, process, and storage. In the analytical phase, the sensitivity/specificity, linearity, precision, limit-of-detection, accuracy, reproducibility, repeatability, and robustness of the assay must be illustrated