VolitionRx's Sepsis Biomarker Selected for €6.3 Million French National Healthcare Initiative
核心洞察
VolitionRx (搜索)'s Nu.Q NETs H3.1 assay (搜索) has been selected as the exclusive biomarker for DETECSEPS, a French government-funded initiative evaluating early sepsis (搜索) detection methods with €6.3 million in funding.
The biomarker shows strong correlation with disease severity and provides excellent prognostic utility for outcomes including organ failure (搜索) and mortality, with prognostic power exceeding established severity scores like APACHE II and SOFA.
The assay can deliver results within one hour using automated analyzers, potentially transforming emergency care pathways for patients with infection and sepsis (搜索) risk.
VolitionRx (搜索) Ltd. has achieved a significant milestone with the selection of its Nu.Q NETs H3.1 assay (搜索) as the exclusive biomarker for DETECSEPS, a French government-funded initiative aimed at transforming early sepsis (搜索) detection. The program, part of the France 2030 plan, has been awarded approximately €6.3 million (~$7.3 million) by the French government and represents a key national strategic axis led by the IHU SEPSIS (搜索).
Clinical Validation and Performance
Professor Djillali Annane, Scientific Director of DETECSEPS and head of the Intensive Care Department at IHU SEPSIS (搜索), Raymond Poincaré Hospital, highlighted the biomarker's robust clinical performance. "Results show that H3.1 (搜索) accurately distinguishes sepsis (搜索) from non-infectious systemic inflammation, is highly correlated with disease severity, and provides excellent prognostic utility for outcomes such as organ failure (搜索) and mortality," Annane stated.
The biomarker's diagnostic capabilities have demonstrated superiority over existing clinical tools. According to Annane, "The prognostic power of H3.1 (搜索) measured at ICU admission significantly exceeded existing severity scores such as APACHE II and SOFA scores." This enhanced performance could significantly improve early sepsis (搜索) identification when combined with the clinical NEWS2 (搜索) score in emergency settings.
Rapid Diagnostic Implementation
Dr. Andrew Retter, Volition's Chief Medical Officer, emphasized the practical advantages of the technology in emergency care. "H3.1 (搜索) levels can be routinely measured using the Immunodiagnostic Systems (IDS) i10 automated analyzer, provided by Euroimmun (搜索), with results available within one hour," Retter explained. This rapid turnaround time represents a crucial advancement for emergency decision-making processes where time-sensitive interventions can be life-saving.
The DETECSEPS program aims to implement a novel early screening strategy that combines the NEWS2 (搜索) clinical score with Volition's Nu.Q H3.1 (搜索) biomarker. Professor Sébastien Beaune, Emergency Department Coordinating Investigator at IHU SEPSIS (搜索), Ambroise Paré Hospital, noted that this approach could enable more precise care pathways, including early discharge decisions for low-risk patients and immediate initiation of the "3-hour bundle" measures recommended by the Surviving Sepsis (搜索) Campaign for high-risk cases.
Addressing Global Healthcare Burden
The initiative addresses sepsis (搜索) as a critical global healthcare challenge with substantial socioeconomic impact. According to data cited in the program, sepsis affects approximately 166 million cases worldwide annually, resulting in 21.4 million deaths in 2021. The disease's impact extends beyond acute mortality, with 33% of patients dying within one year of sepsis, 40% of survivors requiring hospital readmission within 90 days, and one-sixth experiencing significant long-term morbidity including functional limitations.
Professor Beaune emphasized the program's potential for broader impact: "DETECSEPS aims to significantly contribute to reducing the socio-economic burden of sepsis (搜索) by proposing a radical change in the emergency care pathway for patients with an infection and at risk of progressing to sepsis."
Strategic Partnership and Market Implications
The collaboration represents a model for public-private partnerships in medical innovation, with Volition providing the Nu.Q H3.1 (搜索) Assay pro-bono to support the national evaluation. Remi Rabeuf, VP Corporate Alliances and Strategic Partnership at Volition, highlighted the program's scalability potential: "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."
The DETECSEPS consortium brings together leading institutions including Université Paris-Saclay, CEA, AP-HP, Inserm, and their academic and industrial partners. As industry partners, Volition provides the sole biomarker while Euroimmun (搜索), part of Revvity, supplies the automated analyzer technology.
Clinical Research Foundation
The IHU SEPSIS (搜索), which leads the initiative, represents a comprehensive center integrating research, training, and healthcare with the ambitious goal of halving sepsis (搜索) mortality and long-term complications within ten years. The institute's research community comprises 60 research teams with 275 researchers and has produced over 6,800 scientific publications and filed 115 patents over the past five years.
The program's real-world evaluation approach reflects growing recognition of the need for molecular diagnostics in critical care settings, where traditional diagnostic methods often lack the speed and accuracy required for optimal patient outcomes. Successful implementation could establish new standards for sepsis (搜索) management across healthcare systems globally.