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

  • Email
  • Help
Current version

Concept paper

Deadline for comments: 15 November 2017

Reference numberEMA/CHMP/800914/2016
Effective from 
KeywordsCompanion diagnostic (CDx), in vitro diagnostics (IVD), co-development, biomarkers, assay development, platforms, genetic testing, -omics, drug development
DescriptionThe 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.

Related content

How helpful is this page?

Average rating:

 Based on 15 ratings

Add your rating:

See all ratings
3 ratings
3 ratings
3 ratings
3 ratings
3 ratings

Tell us more