The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface between personalised medicines and companion diagnostics.
Companion diagnostics are defined by the In Vitro Diagnostic Regulation as a medical device which allows identification of patients who are most likely to benefit from a medicinal product. Companion diagnostics also permit the identification of patients likely to be at increased risk for serious adverse reactions from a medicinal product.
The concept paper highlights that the current legislation does not directly link medicinal products with companion diagnostics. According to EMA, the envisaged guideline could provide guidance on how evidence to support the validation of a companion diagnostic can be generated during the development of a medicinal product. In particular, the concept paper discusses the potential to align technical assay validation and clinical evidence requirements for medicinal product approval with technical and clinical performance requirements for CE marking.
The concept paper also refers to the post-authorisation phase for medicinal products. During this phase, it is essential that companion diagnostics used for treatment with a medicinal product are adequately validated and sufficiently assured. The proposed guideline will examine concordance testing and bridging studies, including testing of stored patient samples.
The envisaged guideline will also provide a glossary defining specific terms like: analytical, clinical validation, clinical utility, concordance studies and validation sets.
The concept paper has been released for public consultation. Medical product developers, notified bodies or any other interested parties can submit their comments until 15 November 2017.