Predictive biomarker-based assay development in the context of drug development and lifecycle

Current version - concept paper

Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle

Consultation dates: 28/07/2017 to 15/11/2017Draft: consultation closedReference Number: EMA/CHMP/800914/2016

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.