VolitionRx Limited Announces Inclusion of its Nu.Q® NETs Assay as Innovative Biomarker in France's Real-World Evaluation of Early Detection of Sepsis
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."
- 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
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.
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Louise Batchelor, Volition, [email protected] +44 (0)7557 774620
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