PRELUDE is Elypta's EIC Accelerator project aimed at launching the world’s first metabolism-based liquid biopsy for lung cancer risk stratification. Elypta, a Swedish diagnostics company, is developing the LC-Test, a low-cost, minimally invasive blood test that quantifies glycosaminoglycans (GAGs) - biomarkers deregulated early in cancer development - to predict an individual’s lung cancer risk. The LC-Test addresses critical gaps in current lung cancer screening programs, which rely heavily on age and smoking history and often fail to identify other individuals at elevated risk for cancer. Elypta’s test has the potential to improve current risk stratification models, screening uptake, and expand screening eligibility. It is designed for decentralized use, compatible with standard LC-MS/MS instruments, and supported by Elypta’s proprietary MIRAM® kit and SKY software. Through kit development efforts and multiple clinical studies, both completed and underway, Elypta has demonstrated the superior performance of GAGs over many existing methods, including cfDNA-based approaches, particularly in lung cancer risk prediction and early-stage detection. The test is expected to be CE-marked by 2028 and integrated into national screening programs in the UK and EU, facilitating more targeted and equitable lung cancer screening. Elypta seeks €2.5M in EIC funding to finalize kit development, validate the test using existing biobank samples, and prepare for market launch. The project aligns with EU health priorities, offering scalable, cost-effective cancer prevention. By 2033, Elypta projects €74M in revenue and expansion to 135 employees, contributing to public health, economic growth, and sustainable diagnostics innovation.

We propose an ambitious yet well-conceived and deliverable pan-European, pan-cancer, pan-disciplinary, and multi-omic approach to address the pressing unmet need for an accurate, non-invasive, acceptable and cost-effective method of detecting precancerous and early-stage cancers in those individuals with Lynch syndrome (LS), the most common monogenetic increased hereditary cancer risk. LS has historically been underfunded and underserved, leading to significant an inequality in access and treatment. As a result, LS carriers have suffered needless cancers and deaths as a result. Our consortium has brought together the leading European experts, biotechnology companies and patient advocates to guarantee deliver practice-changing results that can be rapidly upscaled and adopted across the European Union and globally. Using an innovative clinical trial design, we will evaluate several multiple promising, non-invasive, liquid biopsy-based technologies in the three most common LS cancer types for an early-stage cancers detection. By leveraging Artificial intelligence (AI), we will identify traces of cancer, ensuring applicability to diverse healthcare systems. A comprehensive framework will assess the broader socio-economic and ethical impacts, ensuring that the solutions align with the societal values and healthcare needs. Parterning with leading biomarker companies (GNT, MSInsight, MSICare, MSIPlus and Elypta), we aim to deliver a multi-omic solution for affordable, accessible and effective test to advance the detection of heritable cancer detections in LS. This action is part of the Cancer Mission cluster of projects on “Prevention & early detection (early detection heritable cancers).

Former cancer patients receive regular follow-ups to detect recurrences at early stages and optimize treatment outcomes. The follow-up frequency is currently limited by costs and radiation risks of imaging approaches used to surveil for recurrences, resulting in recurrences being detected too late – often resulting in terminal disease. Of the 139.000 annual Renal Cell Carcinoma (RCC) patients, 20% are diagnosed with a metastatic recurrence within 5 years after surgery. Once metastatic, RCC survival rates drop to 12% over 5 years survival. Elypta, Sweden, has developed the first metabolism-based liquid biopsy to detect early-stage recurrences. The quantification of a metabolite signature in blood or urine and an algorithmic analysis allows for exceptional sensitivity, a low cost of the platform and significantly improves on imaging approaches in cost and risk, enabling frequent patient follow-up. Elypta’s technology has been demonstrated in small clinical trials and its cost effectiveness assessed by two independent companies. Elypta’s platform is easily scalable to other cancer indications and applications such as treatment monitoring, as demonstrated in multiple small trials. Starting in the niche RCC market with limited competition, Elypta now requires clinical evidence for a product launch within RCC. The business strategy focuses on distribution and sales through clinical laboratories, which will benefit financially off sales. During the AURORAX, Elypta will 1) perform a clinical validation trial (AUR87A) to generate strong clinical evidence, 2) obtain regulatory clearance in the EU and the US and 3) introduce the product for research use only (RUO) and after clinical validation enter the RCC diagnostics market in EU. As users of the platform, oncologist and urologists have all signed letters of support. A pharmaceutical partner has also signed a letter of support, expressing their interest in RUO use of the platform, providing a solid basis in the emerging liquid biopsy market (€200B market).