Novel biomarkers for diagnosis, prognosis, targeted therapy and clinical trials

Biomarkers have been used for clinical diagnosis of multiple diseases for many years, for example, troponin level for diagnosing myocardial infarction, creatinine for diagnosing renal insufficiency, and amylase for pancreatitis. Due to the objective values and convenience of measurement with automated technology in the modern era, the applications of biomarkers in biomedicine are increasingly broader and vastly important. Immunophenotyping by flowcytometry study of cell surface markers has become an indispensable tool that hematooncologists and hematopathologists rely on for diagnosing hematological malignancies and monitoring minimal residual diseases. Immunohistostaining of molecular markers have been widely used for identifying cancer types. FLT3 and nucleophosmin (NPM1) mutations are playing important roles in individualizing treatment decisions on acute myeloid leukemia. The applications of gene chips and microarray technology to simultaneously assess multiple molecular markers are catching up to replace single biomarker testing in guiding clinical practice and are being commercialized faster than ever. As an example, Oncotype Dx breast cancer test, a 21-gene panel assay, provides personalized prediction of breast cancer relapse risk and can potentially reduce unnecessary adjuvant chemotherapy.Targeted agents are revolutionizing the cancer therapy. From monoclonal antibodies (MoAb) to small molecule inhibitors (SMIs) and immunoconjugates, more and more targeted agents are quickly migrating from bench to bedside. Rituximab, a MoAb against CD20, has essentially changed the natural history of diffuse large B cell lymphoma, and is effective in other B-cell disorders such as rheumatoid arthritis. Trastuzumab, a MoAb blocking Her2/neu, is an indispensible agent for Her2/neu positive breast cancer and metastatic gastric cancer. Bevacizumab, a MoAb binding vascular endothelial growth factor (VEGF), has been approved for the treatment of a broad spectrum of advanced mal