Volition Announces MARS Consortium Clinical Study Suggests Nu.Q® H3.1. Concentrations are Closely Associated with Sepsis and Organ Failure
- Large-scale independent study of 1,713 patients validates Nu.Q® H3.1 biomarker's clinical effectiveness
- Study demonstrates potential commercial opportunity in multi-billion dollar market
- Nu.Q® H3.1 shown to be effective in monitoring multiple critical conditions including sepsis and organ failure
- Peer-reviewed publication adds credibility to the technology's clinical applications
- Product positioned as monitoring tool rather than traditional diagnostic test, which may limit market applications
- Commercial timeline and regulatory pathway not specified in the announcement
Insights
Volition's Nu.Q® H3.1 biomarker shows promise for sepsis assessment in ICU patients, validating its technology for a potential multi-billion dollar market.
This newly published clinical study on Volition's Nu.Q® H3.1 biomarker represents significant scientific validation through a large-scale (1,713 patients) independent, peer-reviewed investigation. The findings demonstrate that this biomarker specifically measures NETosis—a biological process increasingly recognized as crucial in critical illness—and correlates with sepsis presence, organ dysfunction severity, and hyperinflammatory responses.
What sets this biomarker apart is its biological specificity. Rather than being a general inflammatory marker, Nu.Q® H3.1 detects H3.1 nucleosomes released during NETosis, providing mechanistic insight into the underlying pathophysiology. This specificity could enable more targeted interventions compared to current ICU assessment tools.
The biomarker shows particular promise for patients with acute kidney injury, disseminated intravascular coagulation, and acute respiratory distress syndrome—all devastating complications with high mortality rates. The study positions Nu.Q® H3.1 not merely as a diagnostic but as a "dynamic tool" for prognostic enrichment and therapeutic monitoring, suggesting potential applications throughout the patient journey.
Most intriguingly, the researchers highlight the possibility of treating excessive NETosis in patients with elevated Nu.Q® H3.1 levels, pointing toward potential companion diagnostic applications. This aligns with the growing trend toward precision medicine in critical care, where treatments are tailored to specific biological mechanisms rather than syndromic presentations.
While the study doesn't provide traditional diagnostic performance metrics (sensitivity/specificity), its focus on biological mechanisms and patient stratification represents a more sophisticated approach to critical care diagnostics than simple binary assessments.
Peer Reviewed Clinical Study for H3.1 Biomarker Published in Critical Care
Dr. Andrew Retter, Chief Medical Officer, Volition said:
"This independent peer-reviewed and published study (1713 patients) clearly demonstrates that Nu.Q® H3.1 is a clinically meaningful, biologically specific marker of NETosis, with actionable potential in defined patient subgroups."
"H3.1 nucleosomes reflect the biological process 'NETosis,' supporting the emerging paradigm of "treatable traits" and biologically-informed risk stratification of patients."
"This evidence positions the assay not as a traditional rule-in/rule-out diagnostic, but as a dynamic tool for prognostic enrichment, therapeutic targeting, and clinical monitoring."
Lieuwe D.J. Bos, PhD, ICU Research, Principle Investigator at the Amsterdam University Medical Center,
"In this large observational study, we demonstrated that plasma nucleosomes, represented by H3.1 nucleosome concentration, are associated with the presence of sepsis, the severity of organ dysfunction, and a hyperinflammatory host response."
"Patients with acute kidney injury (AKI), disseminated intravascular coagulation (DIC), and acute respiratory distress syndrome (ARDS) exhibit significantly higher Nu.Q® H3.1 levels compared to those without these conditions."
"The implications of our results are that NETosis, and H3.1 nucleosomes in particular, play at the intersection of infection, organ failure and inflammation and is not simply a surrogate marker of these conditions."
"This in turn opens up the opportunity of how excessive NETosis can be treated in patients with evidence of a high NETosis phenotype as measured by Nu.Q®H3.1."
Gael Forterre, Chief Commercial Officer, Volition commented:
"This is significant, not only for clinicians, patients and their families, but also for Volition: a peer reviewed publication of a large independent clinical study strongly supports our efforts to commercialize our Nu.Q® NETs product in this multi-billion dollar market."
The published study can be found HERE.
About the Study
This study aimed to evaluate H3.1 nucleosomes in critical illness, assessing their relationship with sepsis, organ failure, inflammatory subphenotypes and outcomes.
The MARS cohort was used, comprising of consecutive Intensive Care Unit patients (n=1713 patients), with plasma samples collected on days 0, 2 and 4 (n=3671 plasma samples).
H3.1 nucleosome concentrations were measured using the Nu.Q® NETs Immunoassay at baseline and longitudinally.
The relationship between H3.1 nucleosome concentrations and clinical outcomes was investigated.
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
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:
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Safe Harbor Statement
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SOURCE VolitionRx Limited
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