Volition Announces Landmark Clinical Validation of Nu.Q® NETs Biomarker in Sepsis
Rhea-AI Summary
Volition (NYSE American: VNRX) announced peer-reviewed clinical validation of its Nu.Q® NETs H3.1 biomarker in sepsis, published in Critical Care Medicine alongside an independent editorial. The study reports Nu.Q® NETs H3.1 as an independent predictor of 28-day mortality and need for renal replacement therapy in sepsis and septic shock patients.
The paper shows higher biomarker levels in septic shock than sepsis, and a dose-response relationship with acute kidney injury severity, suggesting potential utility for early risk stratification and intervention. Volition noted that these findings support ongoing licensing discussions in a sepsis-related diagnostics market it estimates at a $2.8 billion total addressable market.
Positive
- Peer-reviewed validation of Nu.Q® NETs H3.1 as independent predictor for 28-day mortality and renal replacement therapy in sepsis
- Large-scale independent clinical study published in Critical Care Medicine with accompanying editorial highlighting potential biological subgroup identification
- Clear dose-response relationship between H3.1 levels and acute kidney injury severity in sepsis patients
- Supports commercial licensing discussions in diagnostics, including sepsis, linked to a stated $2.8 billion total addressable market
Negative
- None.
Market reaction after Sepsis clinical data: VNRX +7.07%
Following this news, VNRX has gained 7.07%, reflecting a notable positive market reaction. Our momentum scanner has triggered 7 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $0.41. Trading volume is exceptionally heavy at 31.2x the average, suggesting very strong buying interest.
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Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 13 | 2Q26 earnings report | Neutral | -14.8% | Revenue was broadly consistent while losses, cash use, and financing activity remained material. |
| Aug 12 | Sepsis test update | Positive | -7.7% | Finger-prick Nu.Q NETs testing showed strong correlation with the laboratory assay. |
| Aug 11 | Earnings call scheduling | Neutral | -7.7% | The company scheduled its second-quarter earnings and business update conference call. |
| Aug 05 | Liquid biopsy publication | Positive | +1.2% | Volition published its first peer-reviewed paper on Capture-Seq liquid biopsy technology. |
| Jul 30 | Nu.Q NETs platform update | Positive | +3.5% | New clinical evidence supported Nu.Q H3.1 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 positive platform news had mixed reactions, with two aligned gains and one divergence; neutral scheduling and earnings updates also diverged.
Key Terms
renal replacement therapy medical
nucleosomes medical
dose-response relationship medical
netosis medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Published in Critical Care Medicine, findings confirm high-predictive accuracy for severe sepsis outcomes, driving commercial momentum across Volition's
Entitled "H3.1 Nucleosomes to Predict Renal Replacement Therapy and Mortality in Sepsis—A Secondary Analysis of the SISPCT Randomized Control Trial1" and published in Critical Care Medicine, the findings demonstrate Nu.Q® NETs H3.1 is a promising novel biomarker for early mortality and organ dysfunction in sepsis, with significantly higher levels found in septic shock than sepsis patients and a clear dose-response relationship with acute kidney injury severity. These findings indicate that Nu.Q® NETs H3.1 has potential clinical utility for risk stratification and early intervention in critically ill patients presenting with sepsis.
Critical Care Medicine also published an Editorial entitled "H3.1 Nucleosomes in Sepsis: A Biomarker, a Mechanism or Both?2" which concludes:
"Ultimately, the clinical value of H3.1 may lie less in its ability to predict outcomes than in its potential to identify a biologically distinct subgroup of patients with NET-mediated organ injury."
Dr Andrew Retter, Medical Consultant, Volition, said:
"We are honored that Nu.Q® NETs H3.1 featured in an editorial2 in Critical Care Medicine, a prominent journal for Critical Care doctors around the world and are excited to publish the findings of this large-scale independent clinical study.
"Nu.Q® NETs, Volition's nucleosome quantification technology, is a simple, low-cost, accessible test to detect diseases associated with NETosis. Although NETs play a critical role in our normal immune response, elevated levels of NETs can lead to tissue damage and, in severe cases, sepsis, organ failure, and death. These findings advance our understanding of nucleosome biology in critical illness and help inform future therapeutic strategies.
"Introducing Nu.Q® NETs into hospitals, as a treatable, trackable trait, could lead to new ways of treating sepsis, improve patient survival and the quality of life of survivors."
Professor Michael Bauer, Chair of the Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital,
"Our study establishes H3.1 nucleosomes as a biomarker delineating organ dysfunction in sepsis, particularly for early mortality and the need for RRT. The clear stratification of risk and independence from conventional markers suggests clinical utility.
"Being able to predict a sepsis patient's clinical course early, by using Nu.Q® NETs in clinical practice, could significantly enhance sepsis management, enabling physicians more time to intervene and improve patient outcomes."
Mr. Remi Rabeuf, VP Corporate Alliances and Strategic Partnership, Volition added:
"We are currently advancing several active commercial discussions with significant players in the diagnostic space, including large markets such as sepsis; the findings from this peer-reviewed paper support this ongoing licensing process.
"This paper, together with previously published evidence1,3-5, demonstrates that Nu.Q® NETs should enable clinicians and researchers to anticipate disease, guide treatment decisions, and monitor patients over time, across both acute and chronic conditions.
"Nu.Q® NETs is a simple, low-cost, accessible test to detect diseases associated with NETosis such as sepsis. The market opportunity is significant with a Total Addressable Market of
About Sepsis
Sepsis carries a heavy social, economic and health burden worldwide; there were approximately 166 million cases worldwide resulting in 21.4 million deaths in 20217. Moreover, even survivors of sepsis go on to have significant health problems with
Early detection of sepsis in people with an infection and at risk of deteriorating is likely to have favorable public health impact.
For more information about Volition's technology go to: www.volition.com
- 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
- Crowley H., Rachoin J-S. Crit Care Medicine 2026 https://doi.org/10.1097/ccm.0000000000007321
- Morimont et al. Biomolecules, 2022. https://doi.org/10.3390/biom12081038
- Rahimi et al, Ann Intensive Care 2023. https://doi.org/10.1186/s13613-023-01204-y
- Daan F.L. Filippini et al.. Critical Care, 2025. https://doi.org/10.1186/s13054-025-05415-6
- Data on File: Volition Sepsis 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
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 diagnose and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early diagnosis and monitoring have the potential not only to prolong the life of patients but also 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 additional offices in London and Singapore.
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