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.

News Market Reaction – VNRX

+9.49%

11 alerts

+9.49% News Effect

+13.4% Peak Tracked

-5.1% Trough Tracked

+$4M Valuation Impact

$41M Market Cap

1.0x Rel. Volume

On the day this news was published, VNRX gained 9.49%, reflecting a notable positive market reaction. Argus tracked a peak move of +13.4% during that session. Argus tracked a trough of -5.1% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $4M to the company's valuation, bringing the market cap to $41M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Program funding: €6.3 million (~$7.3 million) Global sepsis cases: 166 million cases Sepsis deaths: 21.4 million deaths +5 more

8 metrics

Program funding €6.3 million (~$7.3 million) French DETECSEPS sepsis early-detection program financing

Global sepsis cases 166 million cases Annual global sepsis incidence cited for 2021

Sepsis deaths 21.4 million deaths Global deaths associated with sepsis in 2021

Post-sepsis 1-year mortality 33% Mortality among sepsis survivors within one year

Readmission within 90 days 40% Sepsis survivors re-admitted to hospital within 90 days

Turnaround time Within one hour Time to get H3.1 results on IDS i10® analyzer

3-hour bundle 3 hours Timeframe for Surviving Sepsis Campaign bundle measures

Journal volume/issue 13(12) Lancet Global Health citation for sepsis incidence study

Market Reality Check

Price: $0.2027 Vol: Volume 2,022,950 is about...

normal vol

$0.2027 Last Close

Volume Volume 2,022,950 is about 0.75x the 20-day average of 2,703,608, indicating muted trading interest pre-news. normal

Technical Shares traded below the 200-day MA of 0.56, with the last price at 0.2873, near the 52-week low of 0.2719 and well off the 0.94 high.

Peers on Argus

Pre-news, VNRX was down 7.38% while peers showed mixed moves: ICCM (-2.65%), TEL...

1 Up

Pre-news, VNRX was down 7.38% while peers showed mixed moves: ICCM (-2.65%), TELA (-5.04%), APYX (-0.99%) declined, whereas LUNG (+1.62%) and CTSO (+6.77%) rose, pointing to stock-specific pressure rather than a uniform sector trend.

Historical Context

5 past events · Latest: Nov 10 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 10	Earnings call notice	Neutral	+0.6%	Scheduled Q3 2025 earnings and business update conference call.
Nov 13	Earnings update	Positive	-4.4%	Reported Q3 2025 revenue growth, lower expenses, reduced net loss, and capital raise.
Nov 25	Commercial milestone	Positive	-10.0%	Announced first commercial sale of Nu.Q® Cancer assays for clinical certification.
Dec 04	Clinical collaboration	Positive	+9.5%	Nu.Q® NETs H3.1 named sole biomarker in French DETECSEPS sepsis program.
Dec 08	Clinical data	Positive	-0.7%	Presented lung cancer Nu.Q® Cancer data at a major conference, highlighting prognostic value.

Pattern Detected

Recent VNRX news has often been fundamentally positive but met with mixed or negative price reactions, with only the French sepsis DETECSEPS inclusion showing a clearly positive alignment.

Recent Company History

Over the last month, VNRX reported several milestones and updates. On Nov 10, it scheduled its Q3 2025 earnings call, followed by Q3 results on Nov 13 showing revenue of $0.6M and reduced losses. On Nov 25, it announced the first Nu.Q® Cancer assay sale for clinical certification. The Dec 4 DETECSEPS inclusion highlighted H3.1 as the sole biomarker in a €6.3M French sepsis program, and on Dec 8 lung cancer abstracts underscored Nu.Q® Cancer’s prognostic potential.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-07-03

The company has an effective S-3 shelf registration dated 2025-07-03, expiring on 2028-07-03, with at least 4 recorded uses via 424B filings in 2025, indicating an established framework for raising additional capital when needed.

Market Pulse Summary

The stock moved +9.5% in the session following this news. A strong positive reaction aligns with pri...

Analysis

The stock moved +9.5% in the session following this news. A strong positive reaction aligns with prior trading around the DETECSEPS news, which previously saw a 9.49% gain on similar details. The announcement underscored Nu.Q® H3.1 as the sole biomarker in a €6.3M French sepsis initiative and highlighted rapid one-hour turnaround on an automated platform. However, the stock’s history of selling off after other positive catalysts and the presence of an active shelf registration suggested that enthusiasm could later moderate.

Key Terms

epigenetics, biomarker, sepsis, icu, +3 more

7 terms

epigenetics medical

"Volition, a multi-national epigenetics company, today announces..."

Epigenetics is the study of how environmental factors and experiences can influence how genes are turned on or off without changing the underlying genetic code. Think of it like a dimmer switch for a light, adjusting the brightness without altering the bulb itself. This process can affect health, behavior, and even how diseases develop, which is important for investors interested in long-term trends in medicine, wellness, and biotech industries.

biomarker medical

"Nu.Q® NETs H3.1 assay in "DETECSEPS", a real-world evaluation..."

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

sepsis medical

"a real-world evaluation of early detection of sepsis."

Sepsis is a dangerous medical condition in which an infection triggers the body's defenses to damage its own tissues and organs, often leading to organ failure and emergency hospital care. For investors it matters because sepsis drives demand for diagnostics, antibiotics, intensive-care treatments and hospital resources, affects healthcare costs and insurer payouts, and can influence the commercial prospects and valuation of companies developing related tests, drugs and devices.

icu medical

"H3.1 measured at ICU admission significantly exceeded existing severity scores..."

An ICU, or intensive care unit, is a hospital ward equipped and staffed to monitor and treat patients with life‑threatening illnesses or injuries that require constant attention and advanced medical support, like breathing machines or continuous medication. For investors, ICU capacity and related costs matter because high demand can signal increased use of hospital services, drive revenue for medical device and healthcare providers, strain a facility’s resources and margins, and influence regulatory and reimbursement pressures—similar to how a factory’s production line affects a manufacturer’s output and costs.

apache ii medical

"exceeded existing severity scores such as APACHE II and SOFA scores"

APACHE II is a scoring system used by hospitals to assess the severity of a patient's illness and predict their chance of survival. It combines various health measurements into a single number, much like a car’s diagnostic code, helping doctors determine the best treatment approach. For investors, it reflects healthcare quality and efficiency, which can influence the financial performance of medical facilities and related industries.

sofa scores medical

"exceeded existing severity scores such as APACHE II and SOFA scores"

Sofa scores are numerical ratings that assess the overall health or performance of a company, project, or investment, much like a report card that summarizes various aspects into a single number. They help investors quickly gauge the stability or quality of an opportunity, guiding decisions by providing a clear snapshot of potential risks and strengths. These scores simplify complex information, making it easier to compare options and make informed choices.

nucleosome medical

"NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients"

A nucleosome is the basic unit of DNA packaging in cells, where a short length of DNA is wrapped around a core of proteins like thread wound on a spool. This arrangement helps control which genes are turned on or off, so changes to nucleosomes can affect disease processes and how cells respond to drugs. Investors watch nucleosome-related science because it underpins many diagnostics, drug targets and regulatory decisions in biotechnology and life sciences.

AI-generated analysis. Not financial advice.

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.