Detours on the Road to Personalized Medicine: Barriers to Biomarker Validation and Implementation

Fiore and D'Avolio examine barriers to biomarker validation and implementation. The explosion in biomarker discovery now taking place in academic and biotech communities has exposed a new obstacle on the road to personalized medicine--neither the research nor the health care ecosystems have evolved capabilities for high-volume validation of potentially useful biomarkers in large populations of patients. The limitations of the existing ecosystem are described in terms of biomarker complexity, clinical research infrastructure, and reimbursement issues.