The evaluation of biomarkers involves several stages:
Discovery Phase In the initial stage, potential biomarkers are identified through exploratory research. This often involves high-throughput technologies like genomics, proteomics, and metabolomics.
Validation Phase Once a potential biomarker is identified, it undergoes validation in a series of studies to confirm its reliability and utility. This phase involves: - Analytical Validation: Ensuring the biomarker can be accurately and reliably measured. - Clinical Validation: Demonstrating that the biomarker is associated with clinical outcomes.
Clinical Utility The final stage involves assessing the biomarker's ability to improve clinical decision-making. This includes evaluating its impact on patient outcomes, cost-effectiveness, and its integration into clinical practice.
