Evaluating the value of genomic diagnostics: implications for clinical practice and public policy.

An important current trend in health care is the move toward personalized medicine. Personalized medicine includes diagnostic and therapeutic interventions, with risk defined through genetics. The key paradigm shift brought about by the advent of personalized medicine is the increased use of in vitro genomic diagnostics. These tests offer the potential of being able to predict which patients are likely to respond to a particular drug, or which patients are likely to develop adverse reactions to a drug. The focus of this paper is the use of genomic diagnostics, and how the increasing development and translation into clinical practice of diagnostic--drug combination products will be adopted into health care delivery. The meaning of value and how to measure it is considered from different perspectives. A novel framework for evaluating the value of genomic diagnostics is proposed. Finally, the implications for regulatory approval and policy are discussed using an illustrative case study.