VolitionRx Aims to Revolutionize Lung Cancer Care with French Reimbursement Bid

HENDERSON, Nev. – January 30, 2026 – Epigenetics firm VolitionRx Limited has announced a pivotal step toward bringing its innovative Nu.Q® Cancer assays into clinical practice, initiating preparations for a reimbursement submission to French government agencies. The move, which could reshape lung cancer management in one of Europe's largest healthcare markets, is actively supported by the prestigious Hospices Civils de Lyon (HCL), France's second-largest university hospital system.

This submission seeks to secure national reimbursement for the Nu.Q® blood tests, which are designed to provide crucial information for managing lung cancer patients. If successful, the initiative could see the test integrated into routine clinical use across France by the end of 2026, marking a significant commercial milestone for VolitionRx and a potential paradigm shift for patients and oncologists.

A New Frontier in Cancer Detection

The challenge in fighting lung cancer often lies in its late detection. In France, the need for better diagnostic tools is particularly acute. A 2020 study revealed that a staggering 78.5% of new lung cancer cases were diagnosed at advanced Stages III and IV, when treatment options are more limited and survival rates are lower. VolitionRx's Nu.Q® technology aims to address this gap directly.

Unlike traditional biopsies that require tissue samples, Nu.Q® is a simple, cost-effective blood test. It operates in the field of epigenetics, detecting and measuring structures called nucleosomes that are released into the bloodstream by dying cells. The specific patterns and modifications of these nucleosomes can indicate the presence of cancer and provide valuable prognostic information.

Professor Léa Payen of Claude Bernard University of Lyon I and HCL, a long-term collaborator with Volition, highlighted the test's clinical potential. "Our results indicate that measuring methylated nucleosome biomarker levels with the Nu.Q® test, at Non Small Cell Lung Cancer diagnosis, can provide valuable information about survival, progression-free survival and, crucially, enhance the identification of patients who may benefit from curative care," she commented. "Nu.Q® Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring. This is a test we plan to use routinely."

Navigating France's Fast-Track for Innovation

VolitionRx is leveraging a specialized French regulatory pathway to accelerate market access. The submission will be made under the 'Innovative Procedures Outside the Nomenclature' (RIHN) framework, a system designed by the French government to provide early, temporary reimbursement for groundbreaking medical technologies while real-world evidence is collected.

This framework, recently reformed and streamlined, is managed by the French National Authority for Health (HAS) and the Ministry of Health (DGOS). It allows innovative diagnostics that have already received regulatory approval, such as a CE mark, to be used and paid for in a clinical setting before they are added to the permanent national reimbursement list. This process is intended to bridge the critical gap between technological readiness and widespread patient access.

Frederic Wuilque, Volition's Vice President of Global Products, expressed optimism about the timeline. "Once the dossier is classified as admissible, we understand that determination of eligibility for reimbursement coverage is mandated to take no more than five months," he stated. This expedited timeline underscores France's commitment to integrating high-impact innovations into its healthcare system.

The Power of Partnership and Market Potential

The strategic importance of this move is amplified by the active support of Hospices Civils de Lyon. As a leading public healthcare institution with 13 hospitals and over 23,000 professionals, HCL's endorsement carries significant weight. Its involvement not only validates the clinical science behind Nu.Q® but also provides a clear pathway for adoption within a major hospital network. HCL's track record as a national benchmark for medical innovation and its high certification level from HAS make it an ideal partner to champion a new diagnostic technology.

"We are honored to have the support of our long term collaborator, Hospices Civils de Lyon," said Gael Forterre, Chief Commercial Officer at Volition. "Reimbursement is the next step on the path to the first use of Nu.Q® in clinical practice."

The commercial opportunity in France is substantial. The country sees approximately 50,000 new lung cancer diagnoses each year, and the French liquid biopsy market is projected to grow robustly, potentially reaching over $875 million by 2033. Successfully entering this market would provide VolitionRx with a crucial revenue stream and a powerful case study for further expansion.

"From a commercial perspective, France is just the beginning," added Frederic Wuilque, noting that the company is already in discussions with hospital networks in other countries and exploring potential licensing of the technology to third-party collaborators.

A Blueprint for Global Commercialization

This French initiative is a cornerstone of VolitionRx's broader global strategy, which prioritizes a low-risk, scalable licensing model. Rather than building a massive internal sales and distribution infrastructure, the company aims to partner with large multinational diagnostic companies that already have a global footprint and established relationships with hospitals and labs. The Nu.Q® NETs assay is already CE-Marked for use across the European Union, providing a solid regulatory foundation for this expansion.

This approach has already been validated in the veterinary market, where VolitionRx's Nu.Q® Vet Cancer test is available in over 20 countries through a network of partners. The company is now applying this successful blueprint to the much larger human diagnostics field, with reports of confidential negotiations underway with over ten prospective partners, including several large-cap entities.

For investors, the French submission has been a clear positive signal, with the company's stock (NYSE AMERICAN: VNRX) gaining over 13% on the day of the announcement. Achieving reimbursement would de-risk the company's commercialization path and could unlock significant value. If VolitionRx and HCL succeed, they will not only improve outcomes for lung cancer patients in France but also provide a compelling model for how to accelerate the adoption of life-saving diagnostic innovations worldwide.