GUIDE.MRD

Advancing personalized approaches in cancer therapy, aiding identification and adaptation of multi-modal treatment (MMT) strategies for improved outcomes depends on clinical implementation of novel diagnostic technologies. For most cancer types the risk-features used to select individuals for adjuvant multimodal therapy are suboptimal, where many patients are overtreated and others undertreated. Liquid Biopsy based circulating tumor DNA (ctDNA) assays may present a novel minimal residual disease (MRD) detection tool. However, despite many blood-based ctDNA diagnostics there is a lack of standardization, harmonization, and robust data to demonstrate clinical validity. The GUIDE.MRD project aims to 1) Close the gap by creating reference standards, benchmarking of ctDNA assays and providing robust clinical validation; 2) Develop patient-centric clinical implementation strategies and determine the utility of ctDNA assays as a prospective decision-making tool to guide choice and timing of MMT and for the assessment of clinical response to treatment. The GUIDE.MRD project consortium consists of academic partners and their associated clinical centers; pharmaceutical, medical technology, and operations companies as well as patient partners, under the umbrella of the Innovative Health Initiative (IHI). Acknowledgement and Disclaimer: This project is supported by the Innovative Health Initiative Joint Undertaking (JU) under grant agreement No 101112066. The JU receives support from the European Union’s Horizon Europe research and innovation programme and EFPIA (including Vaccines Europe), MedTech Europe and LGC Clinical Diagnostics INC. Funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.