The project will build on multiple previous cohort studies that confirmed epigenetic biomarkers (specificaly DNA methylation) as the most stringent predictor of response to biological therapy, zooming in on CD. The project aims to bring personalised treatment selection in CD and other IMID to clinical practice and will look into research for further validation studies to develop a marketable rapid, targeted methylation assay that will then be validated in a unique prospective randomised clinical trial for CD.
Asphalion will be in charge of the Regulatory pathway throughout the project and during the kick-off presented the tasks that shall be performing and the regulatory challenges that lie ahead:
- Regulatory Roadmap
- Regulatory Plans (Design and Development, Risk Management, Usability and Software Validation)
- Quality Control support
- Contact with regulatory bodies and Notified Bodies
- Support during IVD Performance Studies and Performance Study submission
The consortium comprises eighteen participants consisting of clinical, epigenetic, and DNA diagnostics experts, patient organisations, and companies across nine countries to ensure effective communication and commitment to help ease the challenges of patients with Crohn’s disease.
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