Predictive biomarker-based assay development in the context of drug development and lifecycle
Table of contents
The proposed concept paper is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. The guideline will provide recommendations on the interface between predictive biomarker-based assays including CDx, and the development and lifecycle of a medicine.
Keywords: Companion diagnostic (CDx), in vitro diagnostics (IVD), co-development, biomarkers, assay development, platforms, genetic testing, -omics, drug development.