Biomarkers, Cancer Therapy & Clinical Research

Discovery of new biomarkers/validation/technologies

Among hundreds of thousands of cancer biomarkers have been discovered, only few of them have been approved during the past two decades by the FDA for monitoring response, surveillance, or recurrence of cancer. To be a clinically applicable and reliable biomarker, it must be of value for informing clinical decision-making to improve the patient outcome. Initially, CB have to distinguish between people with cancer and those without. In fact, many biomarkers do not achieve beyond this point because the investigators are either unable to develop robust, accurate assay methods, or this biomarker lacks sufficient sensitivity and/or specificity. Actually, there was very low rate (0.1%) of successful clinical translation of biomarker. Developing new cancer biomarkers has been formulated in stepwise manner. About 15 years ago, Hammond and Taube proposed an approach for CB development starting from discovering the marker, developing an assay method for assessment, analyzing its clinical potential preliminarily, standardization of its assay, and finally validation of such biomarker for clinical use.