VolitionRx Highlights Commercial Momentum and Multi-Pillar Execution Across $27+ Billion Total Addressable Markets
Rhea-AI Summary
VolitionRx (NYSE American: VNRX) reported first-half 2026 revenue of $1.4 million, a 112% year-over-year increase, and highlighted progress across sepsis, cancer and veterinary pillars targeting an estimated $27+ billion in annualized total addressable markets.
Nu.Q® NETs was validated as an independent predictor of 28‑day mortality and renal replacement therapy in sepsis, ahead of a ~$7.3 million French DETECSEPS program expected to begin recruitment in the third quarter of 2026. Volition advanced a finger‑prick lateral flow Nu.Q® NETs assay correlated with its CE‑marked automated test, and is pursuing NGO and strategic partnerships, particularly in lower‑income countries.
The company plans a conditional lung cancer reimbursement submission in France by the end of 2026 and published peer‑reviewed Capture‑Seq™ data showing over 95% sensitivity for stage I–II cancers with 95% specificity. In companion animals, Volition submitted a Nu.Q® Vet feline lymphoma manuscript (86% sensitivity, 97% specificity) and anticipates a $5 million milestone after publication. Volition also transferred its Nu.Q® NETs assay onto Sysmex Corporation’s platform and is in active licensing discussions with more than a dozen leading diagnostic and liquid biopsy companies.
Positive
- H1 2026 revenue $1.4M, up 112% year-over-year
- French DETECSEPS program ~ $7.3M sepsis evaluation starting Q3 2026
- Capture-Seq™ validation >95% stage I–II cancer sensitivity with 95% specificity
- Feline lymphoma assay 86% sensitivity, 97% specificity; $5M milestone expected post-publication
- Nu.Q® NETs CE-marked and clinically available; sepsis/NETosis TAM estimated at $3.8B
- Active licensing pipeline discussions with 12+ global diagnostic and liquid biopsy companies
Negative
- None.
Market Reaction – VNRX
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Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 13 | Q2 earnings report | Neutral | -14.8% | Revenue growth was offset by losses, financing activity, and going-concern concerns. |
| Aug 12 | Sepsis diagnostic update | Positive | -7.7% | Finger-prick assay correlated with laboratory testing in critically ill sepsis patients. |
| Aug 11 | Earnings call scheduling | Neutral | -7.7% | Company scheduled its second-quarter earnings and business update conference call. |
| Aug 05 | Capture-Seq publication | Positive | +1.2% | Peer-reviewed paper detailed liquid biopsy technology and early cancer detection results. |
| Jul 30 | NETs platform update | Positive | +3.5% | Clinical evidence supported Nu.Q NETs commercialization and diagnostic-company discussions. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent operational and clinical announcements were followed by negative reactions in four of five events, while the Capture-Seq publication was followed by a positive reaction.
Key Terms
netosis medical
nucleosomes medical
lateral flow assay technical
cfDNA medical
chIP-seq technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Key Highlights:
- Sepsis & NETosis Validation: Peer-reviewed paper and independent Editorial published demonstrating that Nu.Q® NETs is an independent predictor of 28-day mortality and the need for renal (kidney) replacement therapy (RRT) in sepsis and septic shock patients.
$7.3 France due to start recruitment in September 2026. - Demonstrates Clinical Utility of Breakthrough Finger-Prick Detection of Nucleosomes: Expanding global market potential for sepsis testing using lateral flow, thereby potentially greatly expanding the addressable market and utility.
- European Lung Cancer Reimbursement: Plans formal conditional reimbursement submission in
France by the end of 2026 to enable routine clinical use. - First Half Revenue Growth: Reported
$1.4M 112% increase year-over-year. - Feline Lymphoma Manuscript Submission: Submitted for publication the clinical manuscript for the Nu.Q® Vet cancer test in cats;
$5 million - Global Licensing Momentum: Confirms active discussions with more than a dozen of the world's leading diagnostic and liquid biopsy companies, including for technical evaluations.
- Newly Announced Collaboration: successfully transferred Volition Nu.Q® NETs assay onto Sysmex Corporation's platform, in preparation for anticipated broader agreement. Sysmex Corporation is a multi-billion dollar market capitalization company listed on the Tokyo Stock Exchange.
- Capture-Seq™ Platform: Peer-reviewed paper published: validation cohort detected over
95% of Stage I and II cancers, Underscores a$23 billion
Sepsis & NETosis Validation
We were honored that Nu.Q® NETs H3.1 featured in an editorial1 in Critical Care Medicine, a prominent journal for Critical Care doctors around the world and were excited that the findings of another large-scale independent clinical study were peer-reviewed and published2 in that journal. These findings confirm high-predictive accuracy for severe sepsis outcomes, driving commercial momentum across Volition's
The inclusion of our Nu.Q® NETs assay in a real-world interventional evaluation of early detection of sepsis, in a government-backed (
In the first half of 2026, we also reported two new, potentially large, clinical use cases for our Nu.Q® NETs assay beyond sepsis. In conjunction with the Mayo Clinic4, we demonstrated Nu.Q® NETs' potential clinical utility in aiding early risk identification which could inform targeted preventive strategies in acute trauma care4. We plan to further validate with Mayo the use of Nu.Q® NETs in trauma patients.
We have also demonstrated the potential use of Nu.Q® NETs for patient management of a chronic disease, Hidradenitis Suppurativa5, which affects about
NETosis-related diseases beyond sepsis provide an additional
Breakthrough Finger-Prick Detection of Nucleosomes
Excitingly for Nu.Q® NETs we have also made excellent progress in the development and evaluation of our lateral flow prototype assay. This has the potential to strengthen our product portfolio. In April, we reported the technical breakthrough of being able to detect nucleosomes in capillary blood (or finger prick blood) and more recently in August, we reported we have demonstrated correlation of the lateral flow prototype assay and our established CE marked automated Nu.Q® NETs assay in samples of critically ill, confirmed sepsis patients in the Intensive Care Unit.
The ability to rapidly identify high-risk patients at the Point-of-Care by quantifying their nucleosome levels using a finger-prick sample and simple lateral flow device aims to enable quicker clinical decision making and consequently better patient outcomes.
This finger prick sample test could be used at the bedside, in the ER, or even at home in a self-test lateral flow kit, similar to COVID-19 or pregnancy testing, thereby greatly expanding the potential market beyond centralized lab testing.
With recent estimates indicating approximately 166 million cases of sepsis worldwide, the addressable market is huge. All-cause sepsis related deaths in 2021 represented
We are now actively targeting NGO partnerships and strategic collaborations with companies operating in low income countries to accelerate the commercialization and market penetration of our breakthrough Lateral Flow Assay.
Nu.Q® Lung Cancer Reimbursement Submission
Lung Cancer remains the major cause of cancer-related mortality worldwide.
We believe that 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.
Research conducted by our long-term collaborators in
This evidence provides the basis of our European lung cancer reimbursement submission supported by our long-term collaborators at the Hospices Civils de
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. This quarter we participated in our first pre-submission meeting with the authorities and anticipate a follow-up meeting and ultimately a submission in 2026.
Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q® in the human cancer field and, assuming achievement, we anticipate the introduction into routine clinical use in
Capture-Seq™ Breakthrough in Cancer Detection.
We were delighted thar our 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" has been peer-reviewed and published14. This, our first peer-reviewed paper for Capture-Seq™, showcasing both a new method and new biomarkers for the detection of cancer, holding the promise of accurate, low-cost tests for a wide range of cancers.
We also announced over
We are in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development of our Capture-Seq™ technology and undertake technical evaluations with potential licensors. We believe that this technology could, with further development, become very widely used and are actively advancing structured discussions with potential commercial partners to accelerate the integration and launch of this technology as soon as possible.
We believe MCED represents a significant commercial opportunity with Total Addressable Markets on an annualized basis of approximately
Companion Animal Health: Nu.Q® Vet Feline Milestone
We announced the submission of a clinical manuscript reporting the high accuracy of our Nu.Q® Vet Feline prototype assay in detecting lymphoma in cats, the most common cancer in the species17. At
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 - 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 space3.
Our Goal and Vision
We have developed a truly remarkable, versatile platform and have further strengthened our Intellectual Property portfolio as we continue our licensing discussions with more than a dozen of the world's leading diagnostic and liquid biopsy companies. Our goal is to enter into licensing agreements and other arrangements that will bring revenue in the form of up front milestone payments, royalties and/or other recurring revenue.
We are delighted to have grown the commercial interest in the first half with an increase in discussions, including technical evaluations. Discussions are at various stages of the negotiation process across all our different pillars; our laser focus is on executing licensing agreements and we will update you as they progress.
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 realize the opportunities better than Volition.
The Total Addressable Markets3 (TAMs) for our technologies, on an annualized 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)3
Pillar | Estimated Annualized TAM | Status |
Capture-Seq™ Cancer Detection | Peer-reviewed Publication | |
Nu.Q® NETs (Sepsis/NETosis) | CE-Marked / Clinically Available | |
Nu.Q® Vet (Canine/Feline) | Canine is Commercially Available. |
- Crowley H., Rachoin J-S., Crit Care Medicine 2026 https://doi.org/10.1097/ccm.0000000000007321
- Neumann C. et al., H3.1 Nucleosomes to Predict Renal Replacement Therapy and Mortality in Sepsis—A Secondary Analysis of the SISPCT Randomized Control Trial Crit Care Med, 2026 DOI: 10.1097/CCM.0000000000007270
- Data on File: Volition TAM Model
- Navarro, Sergio M. et al., Circulating Nucleosomes Are Elevated In Trauma Patients With Venous Thromboembolism: A Prospective Case-Cohort Study. Shock, 2026.DOI: 10.1097/SHK.0000000000002807
- Styliani Theohar et al., Plasma H3.1-Nucleosomes to Classify Severity and Surrogate Response to Treatment in Hidradenitis Suppurativa : A Cohort Study. medRxiv https://doi.org/10.64898/2026.01.13.26343988
- Bouazzi D, Nielsen SM, Hagan PG, et al. JAMA Dermatol. 2025. https://doi.org/10.1001/jamadermatol.2025.2373
- 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
- Kotronoulas A,et al., Prognostic value of circulating H3K27Me3-nucleosomes in newly diagnosed lung cancer patients: Real-world evidence. PrePrint
- Piecyk M. et al., Prognostic value of baseline circulating trimethylated H3K27 nucleosomes in treatment-intent cohorts of non-small cell lung cancer. PrePrint
- 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
- Couraud S., et al., Baseline values of circulating nucleosomes in Lung Cancer: NUCLEO-LUNG study. Poster ELCC 2024
- Piecyk M. 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
- Pei-Hsing Chen et al., "Nucleosome Liquid Biopsy for Prognostic Stratification in Lung Cancer With Treatment Correlation" Poster 244P ELCC 2026
- Pamart, D., et al., 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. Clin Epigenet (2026). https://doi.org/10.1186/s13148-026-02205-x
- Data on File, Volition
- Canale, Annalisa et al., Evaluation of Circulating H3.1 Nucleosomes in the Plasma of Cats with Intermediate-large Cell Lymphoma, 2026, Available at SSRN: http://dx.doi.org/10.2139/ssrn.6657098
- Vail D, Thamm D, Liptak J, eds. Withrow and MacEwen's Small Animal Clinical Oncology. 6th ed. Elsevier Health Sciences; 2019.
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.
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 contained or referenced herein, including in any 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. Forward-looking statements are those that are not statements of historical fact and instead address predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance. 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 such statements.
These forward-looking statements relate to, among other topics, Volition's expectations regarding revenue opportunities and growth; the effectiveness and availability of its blood-based diagnostic, prognostic and disease monitoring tests; its ability to develop and successfully commercialize such test platforms for the early detection and monitoring of cancer and other diseases; its expectations regarding future publications; and its success in securing, and the terms of, licensing and/or distribution agreements with third parties.
Forward-looking statements are based on current expectations, estimates and projections about Volition's business, in part on assumptions made by management. They are not guarantees of future performance and involve risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those anticipated. These risks and uncertainties include, without limitation: the results of studies testing the efficacy of Volition's tests; failure to develop and commercialize its products, which may prevent it from executing its plan of operations; failure to obtain necessary regulatory clearances or approvals; failure to achieve healthcare system or insurance reimbursement; failure of the marketplace to accept its products; failure to secure adequate intellectual property protection; the highly competitive and rapidly evolving nature of the diagnostics and disease monitoring market, which may render its products obsolete; downturns in domestic and foreign economies; and other risks identified in Volition's most recent Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and other documents filed with the Securities and Exchange Commission.
Forward-looking statements are made as of the date hereof and, except as required by law, Volition undertakes no obligation to update them to reflect future events or circumstances.
Nu.Q®, Nucleosomics™, Capture-PCR™, Capture-Seq™ and rNuQ™ 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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SOURCE VolitionRx Limited