Recent advances in molecular and mass screening technologies have paved the way for discovery of novel diagnostic tests and/or biomarkers for accurate identification of specific diseases and organ injuries. However, new diagnostic tests/biomarkers should be subjected to thorough evaluation before introduction into routine clinical practice. This review focuses on the up-to-date methodology in designing and evaluating diagnostic tests/biomarkers, and assessing their clinical utilities for improving health care efficiency, cost-effectiveness and outcomes. In addition to improved diagnostic utilities, future diagnostic tests should be developed in collaboration with our industrial partners and be applicable at the bedside for disease surveillance.