HENDERSON, Nev., Feb. 25, 2026 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, is pleased to provide a consolidated update on the significant clinical and commercial progress achieved over recent months.
Key Highlights:
- Capture-Seq™ Platform: Paper recently submitted for peer review, underscores a $23 billion[1] annualized opportunity in cancer detection.
- Lung Cancer: Reimbursement submission in France on track; routine clinical use expected by Q4 2026.
- Veterinary Breakthrough: 100% specificity achieved in Feline Lymphoma study; $5M milestone payment anticipated.
- Sepsis & NETosis Validation: Inclusion of the Nu.Q® NETs assay in the $7.3 million government-backed DETECSEPS program in France.
- Licensing Momentum: Company confirms active discussions with ~10 global diagnostic leaders.
Capture-Seq™ Breakthrough in Cancer Detection.
We were delighted to submit for peer review a manuscript entitled "Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: Measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy." This paper showcases both a new method, Capture-Seq™, and new biomarkers for the detection of cancer, holding the promise of accurate, low-cost tests for a wide range of cancers.
This scientific breakthrough has generated a lot of interest with potential licensing partners. We feel that this technology could, with further development, become very widely used and are actively seeking large commercial partner/s to work with us to accelerate the integration and launch of this technology as soon as possible.
We believe this represents a significant commercial opportunity with a Total Addressable Market on an annualized basis of approximately $23 billion[1].
Lung Cancer Reimbursement Submission
In the fourth quarter of 2025, we received our first order for the Nu.Q® Cancer assays for clinical certification ahead of routine clinical use in lung cancer and in January were delighted to announce that preparation of the reimbursement submission is underway, actively supported by the Hospices Civils de Lyon (HCL), France's second largest university hospital system. 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.
Government Funded Interventional Sepsis Study
In December, we also announced the inclusion of our Nu.Q® NETs assay in a real-world interventional evaluation of early detection of sepsis, in a government-backed (~$7.3 million) program in France. The DETECSEPS program provides an opportunity to receive individualized or personalized care, adjusted to the risk of deterioration and progression to sepsis.
Consequently, our tests are expected to be used this year in cancer and sepsis, both devastating diseases, to help save lives in real world hospital settings: an extremely proud moment for our entire team.
Cancer and sepsis are leading causes of death, accounting for approximately a third of deaths worldwide[2-4]. With the first clinical use now imminent, we are about to be part of the solution, through simple, easy to use, low-cost tests.
New Clinical Utility in Hidradenitis Suppurativa
In January, we announced data demonstrating the use of our Nu.Q® NETs assay in patient management for Hidradenitis Suppurativa (HS), a lifelong disease which affects approximately 1% of the world's population[5].
Professor Evangelos J. Giamarellos-Bourboulis, M.D., PhD. co-author of the paper said:
"The findings described in the manuscript demonstrate that for the first time an easy-to-measure blood test, Nu.Q® NETs, can be used to classify patients and to surrogate response to treatment.
"In addition, given the various biologic therapies being investigated, circulating H3.1-nucleosomes is a new blood marker in HS that may be used to initiate trials where treatment guidance for both initiation and early cessation of treatment will be studied."
The Nu.Q® NETs assay is CE-Marked to detect diseases associated with NETosis and is therefore approved and commercially available for clinical use in 27 European Union (EU) member states, the three European Economic Area (EEA) countries not in the EU (Iceland, Liechtenstein, and Norway) and the U.K.
Nu.Q® NETs is a simple, low-cost, accessible test to detect diseases associated with NETosis. The market opportunity for such indications is significant, with a Total Addressable Market of $3.8 billion[1].
Breakthrough Cat Results
We have also reported breakthrough results from a clinical study demonstrating the high accuracy of our Nu.Q® Vet Feline assay in detecting lymphoma in cats, the most common cancer in the species[6]. At 100% specificity, i.e. no false positives, the assay detected over 80% of feline lymphomas[7]. This breakthrough marks the development of what we expect to be the world's first simple, affordable blood-based liquid biopsy test for feline cancer, a significant unmet need in veterinary medicine.
This represents a tremendous commercial opportunity for Volition:
- the publication of this study in a peer reviewed journal is expected subsequently to unlock a $5 million contractual milestone payment.
- we will also generate ongoing revenue, in this large and growing market where our technology meets an unmet need.
The Nu.Q® Vet Canine test is already available in more than 20 countries, and we believe the addition of a feline equivalent could potentially double our total addressable market in the companion animal space[1].
Our Goal and Vision
Our goal is to secure a wide range of licensing agreements in the human diagnostics space, mirroring our successful strategy in the veterinary market, and we anticipate diverse deal structures, with potential for up-front and milestone payments, and future recurring revenue.
We have developed a truly remarkable, versatile platform and have further strengthened our Intellectual Property portfolio as we continue our licensing discussions with around 10 of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of the negotiation process across all our different pillars, and we anticipate announcing additional agreements during 2026.
Our vision is for our technologies to be incorporated into tests that will be used first by millions, and ultimately, hundreds of millions of people and animals a year, with our platform licensed to a range of large diagnostic and liquid biopsy companies (and governments) worldwide. Combining our groundbreaking technology with their installed base of laboratories, analyzer machines and sales forces around the world will achieve the optimal outcome for us - large companies have the resources to realise the opportunities better than Volition.
The Total Addressable Markets[1] (TAMs) for our technologies, on an annualised basis, are multi-billion-dollar opportunities, not only for Volition, but for our licensing partners. Volition has made strong progress, both clinically and commercially, and our technology is now poised to be used very widely in a broad range of clinical utilities.
Summary of Addressable Markets (TAM)[1]
Pillar Estimated Annualized TAM
Status
Capture-Seq(TM) Cancer Detection
$23 Billion Manuscript in Peer Review
Nu.Q(R) NETs (Sepsis/Chronic)
$3.8 Billion CE-Marked /Clinically
Available
Nu.Q(R) Vet (Canine/Feline)
$1.0+ Billion Canine is Commercially
Available
- Data on File: Volition TAM Model.
- Gray, Authia P et al. Global, regional, and national sepsis incidence and mortality, 1990-2021: a systemic analysis. The Lancet Global Health, 2025; 13(12): e2013-e2026. doi: 10.1016/s2214-109x(25)00356-0.
- Haem Rahimi M, et al. Association of pronounced elevation of NET formation and nucleosome biomarkers with mortality in patients with septic shock. Ann Intensive Care. 2023 Oct 17;13(1):102. doi: 10.1186/s13613-023-01204-y.
- Morimont, L., et al. (2022). NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients: An Observational Study. Biomolecules, 12(8), 1038. doi: 10.3390/biom12081038
- Bouazzi D, Nielsen SM, Hagan PG, et al. JAMA Dermatol. 2025. https://doi.org/10.1001/jamadermatol.2025.2373.
- Vail D, Thamm D, Liptak J, eds. Withrow and MacEwen's Small Animal Clinical Oncology. 6th ed. Elsevier Health Sciences; 2019.
- Data on File, Volition.
About Volition
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 or associated video or link 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 or associated video or link 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.
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