LUMEN represents a significant advancement beyond current approaches in lung cancer diagnostics. Existing liquid biopsy technologies, which mainly rely on mutation-based or sequencing assays, often face critical limitations, including high background noise, low sensitivity in early-stage disease, and prohibitive costs that restrict large-scale screening and follow-up use. In contrast, the LUMEN project focuses on epigenetic biomarkers, utilizing an ultrasensitive, precise, and reproducible detection method of methylation signatures, while preserving the simplicity of standard laboratory workflows. A custom microarray platform was developed and optimized for cfDNA analysis, significantly reducing complexity and cost compared to sequencing-based methods. On top of this hardware foundation, an AI-driven analytical model was implemented to identify, select, and classify biomarkers dynamically as additional clinical data accumulate, ensuring continuous improvement of diagnostic accuracy. The algorithm integrates biological and clinical features into a single predictive system designed to support not only detection but also treatment monitoring and disease recurrence.
These technological advances establish LUMEN as a next-generation, cost-effective liquid biopsy platform designed for lung cancer detection and follow-up. In addition, the approach holds considerable socio-economic potential, as it could lower healthcare burden, reduce reliance on invasive tissue biopsies, and improve patient quality of life through earlier and more accurate diagnosis. Looking ahead, the outcomes of the project are expected to provide the foundation for regulatory validation and CE-IVDR/FDA submissions, supporting future commercialization and broad clinical adoption across Europe and beyond.
