Development of cancer diagnostics—from biomarkers to clinical tests

New biomarkers and methods have been emerging to improve cancer diagnosis, classification of cancer subtypes, prognosis and prediction of response to therapy. Insights gained from the role and significance of the biomarkers in tumor tissues and cells will aid in understanding tumorigenesis, metastasis and other disease processes. Diagnostic tests based on such information should enable more precise and objective decision-making about cancer staging, progression and response to therapy. On the other hand, many of the diagnostic techniques that are employed today in medicine have not changed over several decades. The fact highlights the challenges faced by new molecular and cellular technologies in having a real impact on patient management in clinic. One of the key challenges is to demonstrate the clinical value of a diagnostic test. In addition to clinical value, a routine test in clinic needs to be optimized so that the assay can fit into the clinical laboratory workflow and the assay result can be generated timely and reproducibly. The review will focus on development of molecular and cellular diagnostic assays that have the potential to aid clinical decision-making and patient management in oncology. The process described here demonstrates the steps to translate and develop novel biomarkers into quality diagnostic tests that can be readily deployed into clinical laboratories. The examples referenced here illustrate how tissue- and cancer-specific biomarkers, coupled with new molecular technologies, can add value to conventional diagnostic methods by providing standardized, objective and highly informative diagnostic tests.