On behalf of EADO, we are pleased to announce the launch of a joint EADO–EUMelaReg project aimed at integrating circulating tumor DNA (ctDNA) into routine melanoma follow-up. The project will evaluate the clinical utility of ctDNA assessed using Oncobit’s CE-IVDR–marked digital PCR solution to detect relapse and to complement or potentially replace established monitoring approaches. By closely reflecting real-world clinical practice and leveraging the strengths of the EUMelaReg registry, this initiative seeks to advance precision monitoring in melanoma care.
Key aspects of the project include:
- ctDNA testing would be conducted as part of clinical routine, similar to established markers such as LDH and S100.
- This is permissible as a CE-marked (IVDR-compliant) test, OncobitTM PM, is used.
- When performed within routine diagnostics, results can be reported directly to patients.
- All resulting clinical and ctDNA data can subsequently be entered into the EUMelaReg registry.
- A consolidated readout from the registry can then be performed at a dedicated time point (similar to other EUMelaReg publications).
Please reach out to Prof. Dr. Reinhard Dummer or Dr. Claudia Scheckel for more information.