The Regulation of Companion Diagnostics: A Global Perspective

The emerging trend of validated biomarkers, otherwise known as companion diagnostics (CDx), is playing a key role in helping pharmaceutical companies acquire rapid regulatory approval of their targeted therapeutics while saving on development time and costs. In today's challenging regulatory arena, diagnostics-led treatment can improve the reimbursement and market access for drugs. All of this has prompted research in the use of such biomarkers with targeted therapeutics for predicting response to therapy, hence beginning the revolution of personalized medicine. With the current target area being oncology, other therapeutic areas are also now being explored. As an increasing number of pharmaceutical firms are penetrating the CDx arena and looking to partner with diagnostics developers, this does not come without its challenges. The codevelopment process is complex, and many hurdles may need to be crossed before a perfect model can be achieved. To add further to the complexity, the global regulatory landscape for CDx is in a state of flux, making it extremely challenging for industry to keep up with the increasing demands of the regulators. This article provides an overview of the changing regulatory landscape for CDx in some of these key markets and an insight to deal with the challenges associated with developing a successful global regulatory strategy for a CDx product. The views presented in this article are mainly from a diagnostics perspective.