A groundbreaking pan-European initiative has launched to transform early cancer detection for individuals with Lynch Syndrome (LS), a hereditary condition that significantly increases cancer risk. The PREDI-LYNCH project, coordinated by Oslo University Hospital (OUH), has secured €13.6 million in funding from the European Union's Horizon Europe Mission on Cancer.
Swedish molecular diagnostics company Elypta will serve as a main partner in this ambitious six-year project that officially began on May 1, 2025. The initiative brings together 28 partners from 16 European countries, including leading oncology experts, biotechnology companies, and patient advocates.
Addressing a Critical Unmet Need
Lynch Syndrome affects approximately 1 in 440 people of European ancestry, predisposing carriers to develop multiple cancer types at an early age. Despite the high prevalence, only 5% of the estimated 2 million LS carriers in Europe currently receive cancer surveillance.
"There is a clear and urgent need to improve cancer detection for Lynch Syndrome, and the PREDI-LYNCH project is designed to make a true difference in the lives of LS carriers," said Marianna Mirabelli, Director of Clinical Development at Elypta.
The project specifically targets the most common LS-associated malignancies: colorectal, endometrial, and urothelial cancers. Current screening methods for these cancers are often invasive, uncomfortable, and in some cases, ineffective. For instance, gynecological surveillance typically involves painful transvaginal ultrasound and endometrial biopsy procedures, while urothelial cancer lacks established surveillance protocols altogether.
Innovative Multi-Omic Approach
PREDI-LYNCH will evaluate multiple promising liquid biopsy technologies to detect cancer at its earliest stages. Elypta will contribute its proprietary tests based on metabolomic glycosaminoglycan (GAGome) biomarkers in both plasma and urine, which aim to stratify at-risk LS carriers and detect precancerous and early cancerous lesions.
The project will also leverage artificial intelligence solutions to identify cancer traces and ensure the methods can be applied across different healthcare systems. This multi-omic approach seeks to deliver affordable, accessible, and effective testing for heritable cancer detection.
"We are excited to collaborate and contribute our expertise in metabolism-based biomarkers to aid in the early detection of cancers associated with LYNCH Syndrome," said Volker Liebenberg, Chief Medical Officer at Elypta. "Strong partnerships between academia and industry are essential for driving innovation and implementing diagnostic solutions, particularly in the field of rare diseases."
Comprehensive Research Infrastructure
A key component of the project involves developing a unique biobank for Lynch Syndrome patients that will serve as a valuable resource for ongoing research.
"I see this as a great opportunity for the benefit of the Lynch syndrome patients," said Mev Dominguez Valentin, project coordinator and team leader at the Section of Tumor Biology at the Institute of Cancer Research, OUH. "The project will develop a unique biobank for Lynch syndrome patients that will serve as a unique resource for research and understanding on Lynch syndrome for many years to come."
Potential to Change Clinical Practice
Beyond the technical aspects, PREDI-LYNCH will assess socio-economic and ethical consequences to ensure solutions align with patient and societal needs and can be implemented across diverse healthcare systems.
The consortium's work has the potential to establish new standards in early cancer detection for rapid upscaling and clinical adoption across the EU and globally. If successful, the project could fundamentally change clinical practice for Lynch Syndrome management.
Jutta Heix, Head of International Affairs at Oslo Cancer Cluster, emphasized the collaborative nature of the initiative: "It has been a great experience working with all the partners and complementing the consortium. This was possible due to our EU Advisor role supported by Innovation Norway, and we are now looking forward to jointly work towards non-invasive early diagnostics solutions for people with Lynch Syndrome."
The PREDI-LYNCH project will run until 2031, with the long-term ambition of offering effective testing solutions that can significantly improve outcomes for individuals with Lynch Syndrome.
