Translation Research of Novel Biomarker

A biomarker has been defined as “an indicator that can be objectively measured and evaluated of a physiological as well as a pathological processes or pharmacologic responses to a therapeutic intervention.” Millions of biological molecules are related to diseases, but there are only thousands of molecules that can be used as biomarkers in clinical practice. With the increasing demand of clinical medicine development and the rapid development of modern molecular detection and analysis technology, various novel molecular targets of diseases have emerged. There is a certain rule from the discovery of novel biomarkers to the clinical application. At the same time, it is necessary to follow certain principles to establish new experimental diagnostic technology by using novel biomarkers, and carry out demonstration procedures in terms of relevant molecular targets, detection and analysis technology, and ethics in accordance with standard and legal approaches. A novel biomarker usually needs to go through the following processes of translation research procedures from scientific research to clinical application, including discovery, qualification, verification, assay optimization, and clinical validation.