Diagnostics and personalized medicine: observations from the World Companion Diagnostics Summit

On 1-2 December 2010 worldwide leaders in the field of co-diagnostics gathered in Boston, MA, USA, to discuss the state of predictive medicine and the complexities of biomarker implementation and partnering. Flanking the primary conference were three workshops where participants could increase their understanding of companion diagnostic commercialization, best practices from well-known case studies and regulatory guidance and practice. The primary conference reviewed here consisted of 18 lectures and one round table discussion. Topics for the summit included biomarker discovery and validation, partnering between pharmaceutical development and diagnostics companies, commercialization models and evolving regulatory perspectives and guidance. While it is clear that there are many difficulties remaining in making personalized medicine a broad-based reality for all therapeutic areas, it is equally clear that much progress has already been made and that the conference participants are optimistic and dedicated to fulfilling the personalized medicine promise of bringing the right drug to the right patient at the right time.