Companion Diagnostics: Strategies to Optimize Performance in the Era of Precision Medicine

Informed drug development in an era of “precision medicine” requires a clear understanding of the risks and benefits that accompany the pursuit of companion diagnostics, a difficult objective given the complexity and rapid evolution of the field. While business cases for companion approaches typically focus on pricing and volume considerations, there is also a need for careful analysis of the strategy associated with managing clinical development, securing access and reimbursement, and generating product demand among target physicians. Without a full accounting of and appreciation for these factors, it is challenging, if not impossible, to direct an efficient, forward-looking drug-diagnostic program capable of maximizing commercial potential.