ABSTRACT
Developing personalized medicines often requires development of companion diagnostics (CDxs). Several steps have to be taken for successful implementation of CDx-based patient selection approaches, starting in early R&D and continuing throughout the lifecycle of the drug. Identification and preclinical validation of biomarker hypotheses for prediction of response serve as the basis for CDx development as an integral part of the drug development process. Typically, assay development is performed by a diagnostic partner considering the regulatory framework for CDxs in the markets of interest. A cross-functional team providing input on all the various aspects is needed because CDx development is a highly complex process and because it has huge strategic importance for the drug, even beyond co-approval of drug and CDx.
The traditional concept for CDx development resulted in drug–diagnostic pairs. More recently, new approaches such as NGS-based multi-gene panels have begun to evolve and will lead to a major shift of the current CDx concept.
