Personalised medicine is defined as the use of predictive biomarkers (individual’s characteristics and genetic makeup) to decide which treatment or dose would be more appropriate for one patient. As the science progress, more personalised medicines are being developed and approved.
Choice of treatment often relies on the use of a companion diagnostic, an in vitro diagnostic medical device (IVD) defined for the first time in the new IVD regulation (IVDR, EU 2017/746) as:
A device which is essential for the safe and effective use of a corresponding medicinal product to:
- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
- identify, before and/or during treatment, patients likely to be at increased risk for serious adverse reactions as a result of treatment with the corresponding medicinal product.
In order to get new companion diagnostics CE marked, the new IVDR envisages cooperation between Notified Bodies and medicine competent authorities during the conformity assessment.
As the development process of medicinal products and IVDs often are independent, this may results in gaps in evidence and validation when it comes to products approval. In order to assist manufacturers in the development of such products, the EMA has release a concept paper for public consultation. The purpose is to develop a guideline to provide recommendations relating to the interface between predictive biomarker-based assays (including companion diagnostics) and medicinal products during the clinical development and post-approval phases.
The concept paper is accessible here and is open for consultation until 15 November 2017.