VolitionRx Limited Announces the Preparation of Reimbursement Submission for its Nu.Q® Cancer Assays

Rhea-AI Summary

Volition (NYSE AMERICAN: VNRX) is preparing a reimbursement submission for its Nu.Q® Cancer assays to French government agencies, supported by Hospices Civils de Lyon (HCL). The dossier will run alongside clinical certification at HCL under the RIHN framework, with admissibility review followed by a reimbursement decision expected within five months.

The company cites ~50,000 new lung cancer diagnoses and ~65,000 five-year prevalence in France and anticipates routine clinical use in France by Q4 2026 while pursuing international partnerships and licensing opportunities.

Positive

• Reimbursement dossier being prepared with HCL support
• Eligibility decision targeted within a five-month period
• France lung cancer addressable cases: 50,000 new diagnoses annually
• Targeted routine clinical use in France by Q4 2026
• Active international discussions and potential licensing opportunities

Negative

• Reimbursement admissibility required before coverage determination
• Commercial rollout initially limited to France pending reimbursement
• Timing risk: routine use contingent on approval and could be delayed

News Market Reaction – VNRX

+13.50% 2.4x vol

19 alerts

+13.50% News Effect

+15.8% Peak in 10 hr 39 min

+$5M Valuation Impact

$39M Market Cap

2.4x Rel. Volume

On the day this news was published, VNRX gained 13.50%, reflecting a significant positive market reaction. Argus tracked a peak move of +15.8% during that session. Our momentum scanner triggered 19 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $5M to the company's valuation, bringing the market cap to $39M at that time. Trading volume was elevated at 2.4x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Annual lung cancer diagnoses: 50,000 cases Five-year lung cancer prevalence: 65,000 cases Reimbursement review timeline: 5 months +3 more

6 metrics

Annual lung cancer diagnoses 50,000 cases New lung cancer diagnoses per year in France

Five-year lung cancer prevalence 65,000 cases Five-year lung cancer prevalence in France

Reimbursement review timeline 5 months Maximum period to determine eligibility once dossier is admissible

Price change -3.42% 24h move before publication vs prior close

Trading volume 1,355,961 shares Today's volume vs 20-day average of 2,243,711 shares

52-week range position -73.29% vs high Price relative to 52-week high of $0.94

Market Reality Check

Price: $0.1975 Vol: Volume 1,355,961 is below...

low vol

$0.1975 Last Close

Volume Volume 1,355,961 is below the 20-day average of 2,243,711 (relative volume 0.6x). low

Technical Shares at $0.2511 are trading below the $0.51 200-day MA and 73.29% under the 52-week high of $0.94.

Peers on Argus

Sector peers showed mixed, generally mild moves, while scanner data only flagged...

1 Up

Sector peers showed mixed, generally mild moves, while scanner data only flagged ELUT up 9.52%. With limited peer momentum and no same-day peer news, the reaction to this reimbursement update appears stock-specific rather than part of a broad sector rotation.

Historical Context

5 past events · Latest: Jan 27 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 27	Clinical data update	Positive	-0.2%	New Nu.Q® NETs data supporting use in Hidradenitis Suppurativa management.
Jan 20	Commercial expansion	Positive	+8.4%	New lab partnerships to expand Nu.Q® Vet Cancer test access in U.S. and Asia.
Jan 16	Conference sponsorship	Positive	+0.6%	Sponsoring veterinary symposium highlighting Nu.Q® Vet Cancer Test clinical use.
Jan 08	Financing agreement	Neutral	+24.2%	Amended securities purchase agreement for $2.0M gross proceeds via 2026 note and warrant.
Jan 08	Clinical trial results	Positive	+24.2%	Breakthrough Nu.Q® Vet Feline data with high specificity and lymphoma detection.

Pattern Detected

Clinical and commercial expansion updates have often seen positive moves, especially major veterinary data and financing news, while some scientific updates have produced flat or slightly negative reactions.

Recent Company History

Over the past month, Volition has reported multiple Nu.Q®-related milestones, including new Nu.Q® NETs data in Hidradenitis Suppurativa on Jan 27, 2026 and expanded Nu.Q® Vet access on Jan 20, 2026. Veterinary-focused announcements and the feline Nu.Q® Vet Cancer data on Jan 8, 2026 were followed by strong positive price reactions of up to 24.19%, while more specialized scientific updates saw modest or slightly negative moves. The current reimbursement-preparation news in France fits into this ongoing commercialization and evidence-building trajectory for the Nu.Q® platform.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-07-03

The company has an active S-3 shelf registration filed on 2025-07-03 and noted as effective, with at least 4 recorded usages via 424B5 filings, indicating prior access to shelf-based capital raises.

Market Pulse Summary

The stock surged +13.5% in the session following this news. A strong positive reaction aligns with V...

Analysis

The stock surged +13.5% in the session following this news. A strong positive reaction aligns with Volition’s pattern of meaningful moves on commercialization milestones, as seen in prior Nu.Q® data and expansion updates with moves up to 24.19%. Reimbursement preparation in France, supported by Hospices Civils de Lyon and a defined five‑month review window, could be viewed as a key de-risking step. However, existing financing structures and the active S-3 shelf mean capital-raising risk would remain a factor for any sustained strength.

Key Terms

methylated nucleosome biomarker, non small cell lung cancer, progression-free survival, innovative procedures outside the nomenclature

4 terms

methylated nucleosome biomarker medical

"measuring methylated nucleosome biomarker levels with the Nu.Q® test, at Non Small Cell"

A methylated nucleosome biomarker is a measurable piece of genetic material where chemical tags called methyl groups sit on DNA wrapped around protein units (nucleosomes); these patterns can signal disease processes such as cancer. Think of it like finding highlighted sentences in a book that reveal which chapters are damaged. Investors care because such biomarkers can drive diagnostic tests, guide drug development, influence clinical trial outcomes, and affect commercial and regulatory prospects for medical products.

non small cell lung cancer medical

"with the Nu.Q® test, at Non Small Cell Lung Cancer diagnosis, can provide valuable"

A broad category of lung cancers that behave and are treated differently from the faster-spreading small cell type, encompassing several common tumor kinds such as adenocarcinoma and squamous cell carcinoma. Investors care because success or failure of diagnostics and treatments for this large patient group directly affects drug sales, clinical trial outcomes, regulatory approvals and healthcare spending — similar to how a dominant product segment drives an entire supplier market.

progression-free survival medical

"information about survival, progression-free survival and, crucially, enhance the"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

innovative procedures outside the nomenclature regulatory

"under the framework of the "Innovative Procedures Outside the Nomenclature" (RIHN-référentiel"

Medical techniques or clinical services that are new, customized, or performed in ways not listed in the official coding or classification systems used for billing and regulation. For investors this matters because procedures outside the nomenclature can be harder to get reimbursed, more difficult to price and track, and often face greater regulatory scrutiny and adoption uncertainty — like selling a product that has no barcode, making revenue and demand harder to predict.

AI-generated analysis. Not financial advice.

HENDERSON, Nev., Jan. 30, 2026 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the preparation of the reimbursement submission for its Nu.Q® Cancer assays to government agencies in France. The submission will be actively supported by the Hospices Civils de Lyon (HCL), France's second largest university hospital system, and will run in parallel with the previously announced process to achieve clinical certification of the test at HCL.

Professor Léa Payen, Professor in Toxicology and Biochemistry, Claude Bernard University of Lyon I and Hospices Civils de Lyon, France commented:
"We are keen to support the submission of Volition's reimbursement dossier for its Nu.Q® Cancer assays so that we can introduce the test into routine, reimbursed clinical practice in France, through our extensive hospital network, for lung cancer management as soon as possible, hopefully later this year."

"We have worked closely with the Volition team over several years to develop the strong scientific and clinical evidence to support the use of Nu.Q® in the management of cancer patients. 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." ^[1-3]

"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."

Frederic Wuilque, Vice President, Global Products, added:

"With the active support of HCL, we are working towards the submission of our reimbursement dossier before the end of this quarter under the framework of the "Innovative Procedures Outside the Nomenclature" (RIHN-référentiel des actes innovants hors nomenclature).  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."

"There are approximately 50,000 new lung cancer diagnoses in France each year with five-year prevalence of approximately 65,000 cases, thus the opportunity to provide help throughout patient management process is significant, in France alone^[4].
From a commercial perspective, France is just the beginning; the Volition team is actively discussing Nu.Q® Cancer, not only with hospital networks in other countries but also potentially licensing the technology to third party collaborators."

Mr. Gael Forterre, Chief Commercial Officer, Volition concluded:

"We are honored to have the support of our long term collaborator, Hospices Civils de Lyon. Reimbursement is the next step on the path to the first use of Nu.Q® in clinical practice, an exciting prospect which is core to Volition's mission, using our tests to help save lives."

"Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q® in the human cancer field. Once achieved, we anticipate the introduction into routine clinical use in France by the fourth quarter, 2026."

About Reimbursement

The Innovative Procedures Outside the Nomenclature (RIHN-référentiel des actes innovants hors nomenclature) framework allows for the early and temporary support of innovative procedures. This support is contingent upon the collection of data to facilitate the subsequent evaluation of these procedures by the French National Authority for Health (HAS), with a view to their integration into standard practice. Established by the Direction General for Healthcare (DGOS) as part of the development of innovation in healthcare, the RIHN provides a long-term support mechanism for innovative medical biology and anatomical pathology. Between 2021 and 2025, the DGOS led a reform to revitalize the RIHN and refocus it on innovation.

About Hospices Civils de Lyon (HCL)

The Hospices Civils de Lyon (HCL) are partners of the IHU SEPSIS (ex-PROMETHEUS). They constitute France's second-largest university hospital system (CHU). As a leading public healthcare institution, HCL encompasses 13 hospitals across the Lyon metropolitan area, covering all medical and surgical specialties. With over 23,000 professionals, including 5,000 physicians, HCL carries out missions in patient care, education, and research, in close collaboration with Université Claude Bernard Lyon 1 and numerous research institutes. As key contributors to medical innovation and healthcare organization in France, HCL provides high-quality care accessible to all patients. These capabilities are supported by state-of-the-art infrastructures in microbiology, molecular biology, and precision medicine, as well as active participation in clinical research and national surveillance networks.

About Volition

Volition is a multi-national company focused on advancing the science of epigenetics. Volition is dedicated to saving lives and improving outcomes for people and animals with life-altering diseases through earlier detection, as well as disease and treatment monitoring.

Through its subsidiaries, Volition is developing and commercializing simple, easy to use, cost-effective blood tests to help detect and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early detection and monitoring have the potential not only to prolong the life of patients, but also to improve their quality of life.

Volition's research and development activities are centered in Belgium, with an innovation laboratory and office in the U.S. and an office in London.  

The contents found at Volition's website address are not incorporated by reference into this document and should not be considered part of this document. Such website address is included in this document as an inactive textual reference only.

Media Enquiries:

Louise Batchelor, Volition, mediarelations@volition.com +44 (0)7557 774620

Safe Harbor Statement

Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to, among other topics, Volition's expectations related to revenue opportunities and growth, the effectiveness and availability of Volition's blood-based diagnostic, prognostic and disease monitoring tests, Volition's ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases as well as serving as a diagnostic, prognostic or disease monitoring tools for such diseases, Volition's expectations regarding future publications, Volition's success in securing licensing and/or distribution agreements with third parties for its products, and Volition's expectations regarding the terms of such agreements. Volition's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including, without limitation, results of studies testing the efficacy of its tests. For instance, if Volition fails to develop and commercialize diagnostic, prognostic or disease monitoring products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition's failure to obtain necessary regulatory clearances or approvals to distribute and market future products; a failure by the marketplace to accept the products in Volition's development pipeline or any other diagnostic, prognostic or disease monitoring products Volition might develop; Volition's failure to secure adequate intellectual property protection; Volition will face fierce competition and Volition's intended products may become obsolete due to the highly competitive nature of the diagnostics and disease monitoring market and its rapid technological change; downturns in domestic and foreign economies; and other risks, including those identified in Volition's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Nucleosomics™, Capture-PCR™, Capture-Seq™ and Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners. Additionally, unless otherwise specified, all references to "$" refer to the legal currency of the United States of America.

¹. Grolleau E, et al. Circulating H3K27 Methylated Nucleosome Plasma Concentration: Synergistic Information with Circulating Tumor DNA Molecular Profiling. Biomolecules. 2023;13(8):1255. https://doi.org/10.3390/biom13081255
². Couraud S, et al  Baseline values of circulating nucleosomes in Lung Cancer: NUCLEO-LUNG study. ELCC 2024 Poster
^3. Marie Piecyk et al, "H3K27Me3-nucleosome is a strong prognostic biomarker in Non-Small Cell Lung Cancer: interim results from the analysis of up to 832 patients at baseline" Poster 395 ELCC 2025
^4. Global Cancer Observatory 2022 (accessed Jan 20, 2026)

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SOURCE VolitionRx Limited

FAQ

What is Volition (VNRX) submitting to French authorities for Nu.Q® Cancer?

They are preparing a reimbursement submission for Nu.Q® Cancer assays to French government agencies. According to the company, HCL will actively support the dossier and clinical certification will proceed in parallel under the RIHN framework.

What timeline does Volition (VNRX) expect for French reimbursement of Nu.Q® Cancer?

The company expects admissibility then a reimbursement decision within about five months once classified as admissible. According to the company, they aim for routine clinical introduction in France by Q4 2026, subject to review timetables.

How large is the potential patient population in France for Nu.Q® Cancer (VNRX)?

Volition cites approximately 50,000 new lung cancer diagnoses annually and ~65,000 five-year prevalence in France. According to the company, this represents a significant national opportunity for clinical use and patient management.

Will Volition (VNRX) seek to commercialize Nu.Q® Cancer outside France?

Yes, the company is pursuing international hospital discussions and potential licensing to third parties. According to the company, France is the first market and broader commercialization or licensing is actively being discussed.

What support does Hospices Civils de Lyon provide for VNRX's Nu.Q® reimbursement bid?

HCL will actively support the reimbursement dossier and clinical certification process at its hospitals. According to the company, HCL aims to introduce the test into routine, reimbursed clinical practice across its network.