In the EMA’s concept paper, the Agency says drugs and predictive biomarkers (BM) – some of which are considered a companion diagnostic (CDx) under new medical devices regulations – are not developed in an integrated way.
“Developments of medicinal products and IVDs [in vitro diagnostic medical devices] are often independent, coming together only towards the end. This may not be ideal, as there remain gaps in evidence and validations,” said the EMA.
The Agency said it aims to provide guidelines on using a ‘close knit’ development programme linking the two, “and the use of clinical trials to generate evidence required to support validation of the diagnostic.”
Biomarker vs companion diagnostic
In conjunction with IVD regulations, for any medicinal product that has a label recommending the product be used with a predictive BM, the BM will be considered a CDx.
Unlike a BM, a CDx is considered a medical device, and consequently in Europe requires a CE mark to signify that the product meets European Economic Area (EEA) requirements.
Under new medical device laws, the EMA will collaborate with IVD regulations to asses CDx.
Personalised medicine
The EMA said personalised medicine, which it defines as “the targeted use of a treatment in a patient on the basis of the individual’s characteristics and genetic makeup, and the understanding of how the treatment works,” relies on the use of a companion diagnostic device, which can help to assess the most likely patient response to a particular treatment.
“The device can also identify patients who are likely to be at increased risk of serious adverse reactions as a result of treatment with the associated medicine,” said the Agency.
These new guidelines, drafts of which will be available nine to 12 months after the end of the pubic consultation of the concept paper, will replace the reflection paper on co-development of pharmacogenomics biomarkers and assays in the context of drug development.