GUIding multi-moDal thErapies against MRD by liquid biopsies - GUIDE.MRD

Advancing personalized approaches in cancer therapy, aiding identification and adaptation of multi-modal treatment strategies for improved outcomes depends on clinical implementation of novel diagnostic technologies. For most cancer types the risk-features used to select individuals for post-operative adjuvant multimodal therapy are suboptimal, where many patients are overtreated and others undertreated. Liquid biopsy has opened a new diagnostic avenue to detect and monitor minimal residual disease (MRD) in individual cancer patients, especially for selecting patients for multi-modal therapies post-operatively. However, despite many circulating tumor DNA (ctDNA) diagnostics being developed there is a lack of standardization, harmonization, and robust data to demonstrate clinical validity. GUIDE.MRD is a consortium of leading academics, technology companies, pharmaceutical companies, and experts in multi-stakeholder engagements. Together, we will tackle the critical questions by developing reference standards for ctDNA diagnostics, clinically validate promising ctDNA diagnostics and develop data to guide the use of multi-modal therapies with a non-invasive diagnostic test. With robust engagement with regulatory authorities, payers and importantly patients themselves, we will develop recommendations and guidelines based on objective data to use ctDNA diagnostics to guide multi-modal therapy selection to improve patient outcomes.