Periodic Reporting for period 1 - LUMEN (INNOVATIVE LIQUID BIOPSY METHOD USING LAB-ON-ACHIP TECHNOLOGY FOR CANCER DIAGNOSIS AND MANAGEMENT)
Okres sprawozdawczy: 2024-11-01 do 2025-10-31
Lung cancer is the leading cause of cancer-related deaths worldwide, accounting for nearly 1.8 million deaths each year. Despite significant advances in treatment, over 70% of patients are still diagnosed at late stages when the disease is largely asymptomatic and curative treatment options are limited. Current diagnostic tools, such as low-dose CT (LDCT) scans, often produce false or inconclusive results, leading to unnecessary biopsies, delayed diagnoses, and increased healthcare costs. There is also an urgent unmet need for reliable tools to monitor treatment response and detect disease recurrence, especially using non-invasive methods.
To address these challenges, JaxBio has invented an ultra-sensitive diagnostic tool for lung cancer, capable of early detection, therapy prediction, and monitoring of disease progression or recurrence. The LUMEN test analyses DNA extracted from a simple blood sample using an innovative microarray chip combined with an AI-based analytical algorithm. This combination provides a sensitive, affordable, and scalable solution that outperforms current technologies. The overall objective of LUMEN is to bring forward a CE and FDA-approved diagnostic platform that enables early and accurate detection of lung cancer, improves patient management, and reduces the need for invasive procedures.
To address these challenges, JaxBio has invented an ultra-sensitive diagnostic tool for lung cancer, capable of early detection, therapy prediction, and monitoring of disease progression or recurrence. The LUMEN test analyses DNA extracted from a simple blood sample using an innovative microarray chip combined with an AI-based analytical algorithm. This combination provides a sensitive, affordable, and scalable solution that outperforms current technologies. The overall objective of LUMEN is to bring forward a CE and FDA-approved diagnostic platform that enables early and accurate detection of lung cancer, improves patient management, and reduces the need for invasive procedures.
Since its launch, LUMEN has successfully completed the discovery and prototype development phases. Hundreds of cfDNA samples from lung cancer patients and healthy donors were analysed using commercial high-content microchips. These data were processed using JaxBio’s proprietary chemo-enzymatic labelling technology, which enables highly sensitive detection of DNA methylation patterns distinguishing healthy and cancerous states.
From this dataset, a panel of approximately 200 biomarkers was identified based on their ability to accurately differentiate between healthy individuals and lung cancer patients, achieving over 90% accuracy in independent validation sets. Importantly, the test effectively detects early-stage lung cancer (stages I–II) and distinguishes cancer from non-malignant lung diseases such as COPD.
A custom diagnostic microarray (LUMEN chip) was then designed, printed, and validated.
In parallel, a dedicated machine learning–based algorithm was developed to support classification and interpretation. The algorithm integrates scoring models to classify samples as healthy or cancerous and to further stratify by histological subtype, stage, and treatment response.
The clinical study infrastructure has been established, with approval and study initiation in five medical centres in Israel and Europe.
From this dataset, a panel of approximately 200 biomarkers was identified based on their ability to accurately differentiate between healthy individuals and lung cancer patients, achieving over 90% accuracy in independent validation sets. Importantly, the test effectively detects early-stage lung cancer (stages I–II) and distinguishes cancer from non-malignant lung diseases such as COPD.
A custom diagnostic microarray (LUMEN chip) was then designed, printed, and validated.
In parallel, a dedicated machine learning–based algorithm was developed to support classification and interpretation. The algorithm integrates scoring models to classify samples as healthy or cancerous and to further stratify by histological subtype, stage, and treatment response.
The clinical study infrastructure has been established, with approval and study initiation in five medical centres in Israel and Europe.
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.
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.