Protein biomarkers have been hailed as vital stepping stones in the race to personalize medicine. But many hurdles remain to be cleared before their application becomes routine. Currently, protein biomarkers have proven useful in drug discovery and development, as tools for target discovery and evaluation of a drug’s mechanism of action, and in therapies for prevention, early detection, diagnosis, and treatment of disease. Although single markers are in use, more widespread adoption will probably require a multiplexed panel capable of detecting and measuring biomarkers accurately, inexpensively, and easily in biological samples that are highly complex.
Before a biomarker can be put to use, it must undergo several stages of confirmation, validation, and qualification depending on its intended use. Sample preparation involves many challenges. Once an appropriate method has been chosen to isolate and measure the biomarker or pattern of markers, technical parameters of the assay must be defined to establish ...