EMA Issues Concept Paper on Development and Lifecycle of Prognostic Biomarkers and Companion Diagnostics

The European Medicines Agency (EMA) announced on July 28, 2017 that it has issued a concept paper for consultation regarding the development and lifespan of prognostic biomarkers and companion diagnostics. Public comments are accepted until Oct. 31, 2017.

A companion diagnostic is a medical device that identifies patients who are most likely to benefit from a specific medicine or whom are likely to be at increased risk of serious adverse reactions. According to EMA, “it is very important to clarify how evidence to support the validation of a companion diagnostic can be generated during the development of a medicine.”

As the first step in future guideline planning, this draft paper addresses the complexities associated with developing personalized treatments facilitated by companion diagnostics. Although EMA does not issue recommendations on companion diagnostics, recently revised European Union regulation indicates synergistic interactions between medicines regulators and relevant EU notified bodies show potential in the evaluation of new companion diagnostics to obtain CE marking.