VolitionRx Limited announced new clinical data demonstrating the prognostic value of its Nu.Q Cancer Assay for newly diagnosed lung cancer patients. The study indicates the test can help clinicians identify patient outcomes and personalize treatment selection. This development is significant for the company's commercialization efforts in the human cancer field.

The clinical paper, titled "Prognostic value of circulating H3K27Me3-nucleosomes in newly diagnosed lung cancer patients: Real-world evidence," was developed with researchers at Hospices Civils de Lyon. The study found that plasma levels of the Nu.Q Cancer assay H3K27Me3 were associated with cancer stage. Patients with levels below the optimal cut-off showed significantly better mean survival compared to those with higher concentrations.

Clinical Study Findings

The research highlights the test's ability to enhance precision in patient management. Key findings from the study include:

• Risk Stratification: A Cox Proportional Hazards model integrating baseline H3K27Me3-nucleosome concentrations with clinical covariates enabled stratification of patients into low and high-risk mortality groups at diagnosis.
• Survival Prediction: The model facilitates the prediction of patient-level survival probabilities over a timeline of up to 30 months.
• Actionable Insights: The test provides valuable information for patients who are ctDNA-negative and lack detectable actionable mutations.

Dr. Andrew Retter, Medical Consultant at Volition, emphasized the test's potential to refine patient care. He stated that measuring methylated nucleosome biomarker levels at Non-Small Cell Lung Cancer diagnosis can offer insights into survival and progression-free survival.

Commercialization and Reimbursement

Volition is advancing the Nu.Q Cancer Test toward routine clinical use. Frederic Wuilque, Vice President, Global Products, confirmed that clinical certification at Hospices Civils de Lyon is complete. The company is working towards submitting a reimbursement dossier under the "Innovative Procedures Outside the Nomenclature" framework in the coming months.

Gael Forterre, Chief Commercial Officer, noted that France represents the starting point for the company's commercial strategy. Volition is discussing the test with hospital networks in other countries and exploring licensing opportunities with third-party collaborators.

VolitionRx Limited, a multi-national epigenetics company, has entered a collaboration with Sysmex, a leader in global in vitro diagnostics, to optimize Volition's Nu.Q® NETs H3.1 assay on the Sysmex platform. The partnership focuses on enhancing the assay's performance and compatibility with Sysmex's diagnostic systems.

Collaboration Details

The collaboration leverages Sysmex's expertise in in vitro diagnostics to refine the Nu.Q NETs H3.1 assay. This assay is designed to detect nucleosomes, which are biomarkers associated with various diseases, including cancer. By optimizing the assay for the Sysmex platform, Volition aims to improve its accessibility and utility in clinical settings.

Strategic Implications

This partnership aligns with VolitionRx's strategy to expand the reach of its epigenetic diagnostics solutions. Sysmex's established global presence and diagnostic infrastructure provide a robust foundation for the deployment of the optimized assay. The collaboration is expected to enhance the assay's adoption in laboratories worldwide.

Key Objectives

• Optimize the Nu.Q NETs H3.1 assay for the Sysmex platform.
• Improve assay performance and integration with Sysmex's diagnostic systems.
• Expand the clinical utility and accessibility of the assay.

The collaboration underscores the growing importance of epigenetic diagnostics in precision medicine and early disease detection.