Policy perspectives on the emerging pathways of personalized medicine.

Remarkable advances in the fundamental knowledge about the biological basis of disease and technical advances in methods to assess genomic information have led the health care system to the threshold of personalized medicine. It is now feasible to consider strategic application of genomic information to guide patient management by being predictive, preemptive, and preventive, and enabling patient participation in medical decisions. Early evidence of this transition has some hallmarks of disruptive innovation to existing health care practices. Presented here is an examination of the changes underway to enable this new concept in health care in the United States, to improve precision and quality of care through innovations aimed at individualized approaches to medical decision making. A broad range of public policy positions will need to be considered for the health care delivery enterprise to accommodate the promise of this new science and technology for the benefit of patients.