The validation of biomarkers involves several steps:
1. Preclinical Studies: Initial validation is done using cell lines and animal models. Histological techniques are used to evaluate the expression and localization of potential biomarkers.
2. Clinical Samples: Biomarkers need to be tested on human tissue samples. This involves comparing diseased tissues with normal tissues to establish specificity and sensitivity.
3. Statistical Analysis: Rigorous statistical methods are employed to confirm the reliability and reproducibility of the biomarkers. This ensures that the biomarkers are not only accurate but also clinically relevant.