VolitionRx Limited Announces Inclusion of its Nu.Q® NETs Assay as Innovative Biomarker in France's Real-World Evaluation of Early Detection of Sepsis

Rhea-AI Summary

Volition (NYSE AMERICAN: VNRX) announced that its Nu.Q® NETs H3.1 assay has been included as the sole biomarker in DETECSEPS, a French real-world program for early detection of sepsis funded under France 2030.

The DETECSEPS consortium received approximately €6.3 million (~$7.3 million) in government financing. Results cited show H3.1 accurately distinguishes sepsis from non-infectious inflammation, correlates with disease severity, and outperforms APACHE II and SOFA for ICU admission prognostic power. H3.1 can be run on the IDS i10® analyzer with results within one hour. The release highlights a potential national rollout and cites ~166 million annual sepsis cases as a large testing opportunity.

Positive

• €6.3M government financing for DETECSEPS consortium
• Nu.Q® H3.1 selected as the sole biomarker in DETECSEPS
• H3.1 distinguishes sepsis from non-infectious inflammation
• H3.1 shows superior prognostic power vs APACHE II and SOFA
• H3.1 results available within one hour on IDS i10 analyzer

Negative

• None.

Insights

Clinical diagnostics strategist

Inclusion in France's government-funded DETECSEPS consortium strengthens clinical validation and potential clinical deployment for Volition's Nu.Q® NETs H3.1 assay.

VolitionRx Limited gains a clear pathway to real-world evaluation as the sole biomarker partner within the DETECSEPS consortium, which received approximately €6.3 million financing from the French government under the France 2030 plan and was publicly recognised at a ceremony on December 3, 2025. The program pairs the Nu.Q® H3.1 biomarker with the IDS i10® automated analyzer provided by Euroimmun, enabling assay results reportedly available within one hour; this creates a practical operational route to test the biomarker in emergency settings alongside the NEWS2 clinical score.

The main dependencies and risks are execution and demonstrated performance in the planned real-world context: acceptance by emergency clinicians, integration with the IDS i10® workflow, and reproducible diagnostic and prognostic performance versus existing clinical scores. The announcement cites prior evidence that H3.1 distinguishes sepsis from non‑infectious inflammation and correlates with severity, but real-world program results will determine clinical adoption and pathway changes.

Watch for concrete, monitorable outputs from the DETECSEPS program such as published sensitivity/specificity or prognostic metrics, operational throughput on the IDS i10® platform, and any stated timelines for data readouts; the press release date is December 4, 2025, so early program milestones over the next 12–24 months are the most relevant horizon.

HENDERSON, Nev., Dec. 4, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the inclusion of its Nu.Q® NETs H3.1 assay in "DETECSEPS", a real-world evaluation of early detection of sepsis. DETECSEPS Consortium was awarded winner of the "Challenge Prevention" call for proposals launched by the French Health Innovation Agency and operated by the Banque Publique d'Investissement, as part of the France 2030 plan, during the official ceremony held yesterday,  December 3, in Paris, France.  This consortium will be financed with approximately €6.3 million (~$7.3 million) by the French government and is a key national strategic axis. As industry partners, Volition (XASE:VNRX) will provide the sole biomarker and Euroimmun, part of Revvity, will provide the  Immunodiagnostic Systems (IDS) i10® automated analyzer.

Professor Sébastien Beaune, Emergency Department, IHU SEPSIS, Ambroise Paré Hospital (AP-HP)  and Coordinating Investigator of DECTECSEPS program commented:

"DETECSEPS aims to significantly contribute to reducing the socio-economic burden of sepsis by proposing a radical change in the emergency care pathway for patients with an infection and at risk of progressing to sepsis.

"Sepsis carries a heavy social, economic and health burden worldwide; there are approximately 166 million cases worldwide resulting in 21.4 million deaths in 2021¹. Moreover, even survivors of sepsis go on to have significant health problems with 33% mortality within one year, 40% of survivors being re-admitted to hospital within 90 days of discharge and one sixth of survivors experiencing significant morbidity such as functional limitations.

"Early detection of sepsis in people with an infection and at risk of deteriorating is likely to have favorable public health impact."

Professor Djillali Annane, Intensive Care Department, IHU SEPSIS, Raymond Poincaré Hospital (AP-HP) and Scientific Director of DETECSEPS commented:

"DETECSEPS aims to implement in real life an original early screening strategy based on the combination of a clinical score (NEWS2) and Volition's Nu.Q® H3.1 biomarker as the sole biomarker, whose diagnostic performance is well established.

"Results show that H3.1 accurately distinguishes sepsis from non-infectious systemic inflammation, is highly correlated with disease severity, and provides excellent prognostic utility for outcomes such as organ failure and mortality². The prognostic power of H3.1 measured at ICU admission significantly exceeded existing severity scores such as APACHE II and SOFA scores³.

"We believe that combining the two diagnostic tests (NEWS2 and Nu.Q® H3.1) could improve test performance and make a huge difference in terms of early detection in an emergency setting.

"Our aim is to have a positive impact on the care pathway, including early discharge to home (progression to sepsis unlikely or very unlikely), hospitalization in ICU or non-ICU ward, and initiation of the "3-hour bundle" measures recommended by the Surviving Sepsis Campaign (progression to sepsis likely or very likely)."

Dr Andrew Retter, Chief Medical Officer, Volition, added:

"H3.1 levels can be routinely measured using the Immunodiagnostic Systems (IDS) i10® automated analyzer, provided by Euroimmun, with results available within one hour. The addition of the value of our biomarker could potentially enhance the application and reliability of NEWS 2 to triage the sickest patients. I believe that this is both a huge and realistic expectation.

"DETECSEPS aligns with Volition's core purpose of operationalizing our understanding of epigenetics and in particular, of H3.1 in clinical practice, to help identify and monitor the severity of disease. The DETECSEPS program provides an opportunity to receive individualized or personalized care, adjusted to the risk of deterioration and progression to sepsis."

Mr. Remi Rabeuf, VP Corporate Alliances and Strategic Partnership, Volition concluded:

"We are proud to be, alongside Euroimmun, industry members of this Consortium and are delighted that the program has been approved and financed by the French government.

"We hope that through the earlier identification of sepsis lives can be saved, the quality of life of survivors can be improved and importantly that the burden on healthcare systems can be reduced.

"As Professor Beaune said, sepsis carries a heavy social, economic and health burden worldwide; we believe this program could be rolled out not only nationally in France, but also in many other countries around the world. With approximately 166 million cases annually the opportunity for testing represents a multi-billion dollar Total Addressable Market."

1. 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
2. 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
3. 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

About the Consortium

The Hospital-University Institute (IHU 3) SEPSIS (ex-PROMETHEUS) has been accredited under the France 2030 program. Led by Université Paris-Saclay, CEA, AP-HP, Inserm, and their academic, non-profit, and industrial partners, this world-class comprehensive center integrating research, training, and healthcare aims to halve, within ten years, the mortality and long-term complications caused by sepsis.

The institute's interdisciplinary approach places it in a unique position to break down barriers in sepsis research and thereby develop new diagnostic tests and therapeutics. The IHU brings together 60 research teams comprising 275 researchers, as well as several hospitals from AP-HP and the Hospices Civils de Lyon, representing 94 clinician-researchers. Over the past five years, the IHU's scientific community has produced more than 6,800 scientific publications and filed 115 patents.

In the DETECSEPS project, the two hospital partners of the IHU, AP-HP and HCL, are joining forces with two leading industrial partners (IDS France and Volition) to advance sepsis prevention.

About Assistance Publique – Hôpitaux de Paris (AP-HP)

The Assistance Publique – Hôpitaux de Paris (AP-HP), Europe's largest university hospital system, is a Founding Member of the IHU SEPSIS (ex-PROMETHEUS) and contributes its hospital and research expertise to support the institute's ambitions.

With its three core missions—care, training, research and innovation—AP-HP provides care to all individuals who come to its hospitals, trains today's and tomorrow's professionals, and plays a major role in medical research. AP-HP comprises 38 hospitals grouped into six university hospital groups (GHUs). It includes 773 departments organized into 80 medical-university divisions. In the field of research, AP-HP is involved in 11 Hospital-University Institutes (IHUs)—including in which AP-HP is a founding member, and three in which AP-HP is a direct partner—23 active Hospital-University Research Programs (RHUs), including nine coordinated by AP-HP, 26 Hospital-University Federations (FHUs), four Integrated Cancer Research Sites (SIRICs), including one pediatric site, and 181 rare disease reference centers.

The 38 AP-HP hospitals treat nearly 8 million patients each year in outpatient visits, emergency care, scheduled hospitalizations, or home hospitalization, for people of all ages.

Research at AP-HP continuously improves patient care and enables the development of new treatments. Any patient may benefit from the most innovative therapies by participating in a clinical trial. In France, half of all clinical research is conducted within AP-HP hospitals. At the heart of a broad network of partners, AP-HP is the first university hospital in France to receive the Carnot Institute label, recognizing the excellence of its collaborative research.

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.

HCL has recognized expertise in sepsis management, supported by an extensive network of specialized services structured around patient pathways, beginning with emergency departments. HCL includes three major emergency care sites located at Edouard Herriot Hospital, Croix-Rousse Hospital, and Lyon Sud Hospital, which together receive more than 300,000 visits annually. These sites are connected to 15 critical care units across the main hospitals, including multidisciplinary intensive care units (ICUs) in general, medical, surgical, infectious disease, and neonatal care.

Thanks to multidisciplinary teams bringing together emergency physicians, infectious disease specialists, intensivists, biologists, and pharmacists, the response to sepsis is rapid, coordinated, and based on up-to-date protocols and structured patient pathways. 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.

Volition is providing the Nu.Q® H3.1 Assay pro-bono to enable this important evaluation.

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

Investor Relations:
Jeremy Feffer, LifeSci Advisors, jfeffer@lifesciadvisors.com +1-212-915-2568

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.

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SOURCE VolitionRx Limited

FAQ

What did Volition announce about Nu.Q® NETs H3.1 on December 4, 2025 (VNRX)?

Volition announced inclusion of Nu.Q® NETs H3.1 as the sole biomarker in France's DETECSEPS program on December 4, 2025.

How much government funding supports DETECSEPS and when was it awarded?

DETECSEPS received approximately €6.3 million (~$7.3 million) in financing from the French government; the award was announced December 3, 2025.

What clinical performance is reported for H3.1 in the DETECSEPS announcement?

The announcement says H3.1 accurately distinguishes sepsis from non-infectious inflammation and has strong prognostic utility for organ failure and mortality.

Can hospitals get H3.1 results quickly using existing analyzers (VNRX)?

Yes—H3.1 can be measured on the Euroimmun/IDS i10® automated analyzer with results available within one hour.

How might Nu.Q® H3.1 affect emergency triage with NEWS2 for VNRX?

The company says combining NEWS2 and Nu.Q® H3.1 could improve early detection and triage of patients at risk of progressing to sepsis.

What is the implied market opportunity mentioned in the release for VNRX?

The release cites approximately 166 million annual sepsis cases and describes a multi-billion dollar testing opportunity.