Biomarkers in oncology research and treatment: early detection research network: a collaborative approach.

Several important criteria are essential for the development of biomarkers in clinical oncology. First, the biomarkers should be easily measured using standardized and cost-efficient methods. Second, biomarkers should be easily attainable from clinical materials such as body fluids and cells. Third, biomarkers should have clearly defined cutoff values with high sensitivity and specificity. Lastly, the predictive value of biomarkers should be possible in strata as large as possible. Single biomarkers may not be able to meet all of these criteria, which necessitates the development of biomarker panels. High-throughput technologies will be necessary for measuring these biomarker sets and translation of these methods into a clinical setting will be necessary in order to employ these biomarkers in a healthcare setting. One of the most important aspects of biomarker development will be standardization and statistical evaluation of biomarker studies. Guidelines for biomarker studies need to be developed that will enable standardization to take place. The Early Detection Research Network has been in the forefront of this objective. Early detection of cancer through appropriately validated biomarkers will provide for decreased morbidity and mortality and allow for the development of new therapeutic tools targeted specifically toward eradication of these early malignancies, hopefully increasing the survival rate of patients diagnosed with early-stage cancer.