Improving the power of diagnostics in the era of targeted therapy and personalized healthcare.

The field of diagnostics has unprecedented opportunities to contribute to the practice of medicine in the era of targeted therapy and personalized healthcare. Rather than simply providing information regarding the presence and classification of disease, innovative molecular diagnostic tests will directly inform patient-management decisions, such as which targeted therapies to prescribe or whether a patient should be treated more aggressively. However, in order for diagnostics to deliver this high level of medical value, several challenges ranging from technical, pre-analytical, developmental, regulatory, reimbursement and quality perspectives need to be overcome. This review focuses on recent developments in each of these areas that are expected to improve the power and impact of diagnostics.