VolitionRx Limited has announced the publication of a significant clinical study demonstrating that its Nu.Q H3.1 biomarker shows strong associations with sepsis and organ failure in critically ill intensive care unit patients. The peer-reviewed study, published in Critical Care, analyzed 1,713 consecutive ICU patients and represents one of the largest investigations into H3.1 nucleosomes as clinical biomarkers.
Study Demonstrates Clinical Utility in Critical Care
The MARS consortium study evaluated H3.1 nucleosome concentrations across 3,671 plasma samples collected from ICU patients on days 0, 2, and 4. Using Volition's Nu.Q NETs Immunoassay, researchers measured H3.1 nucleosome levels both at baseline and longitudinally to assess their relationship with clinical outcomes.
Dr. Andrew Retter, Chief Medical Officer at Volition, emphasized the clinical significance of the findings: "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."
Strong Associations with Organ Dysfunction
The study revealed that plasma nucleosomes, represented by H3.1 nucleosome concentration, are associated with the presence of sepsis, the severity of organ dysfunction, and hyperinflammatory host response. Particularly notable were the findings regarding specific organ failures.
Lieuwe D.J. Bos, PhD, Principal Investigator at Amsterdam University Medical Center and Senior Author of the study, reported: "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."
Beyond Traditional Diagnostics
The research positions the H3.1 biomarker as more than a conventional diagnostic tool. According to Dr. Retter, "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."
The biomarker reflects NETosis, a biological process involving neutrophil extracellular trap formation. Dr. Bos explained the broader implications: "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."
Therapeutic Targeting Potential
The study's findings suggest new therapeutic opportunities in critical care medicine. Dr. Bos noted: "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."
The research supports the emerging paradigm of "treatable traits" and biologically-informed risk stratification of patients, moving beyond traditional one-size-fits-all approaches to critical care management.
Commercial Implications
Gael Forterre, Chief Commercial Officer at Volition, highlighted the commercial significance: "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 study represents a substantial validation of Volition's epigenetics-based approach to disease monitoring and detection. The company is developing blood-based tests for various diseases, including cancers and conditions associated with NETosis such as sepsis, with research and development activities centered in Belgium and facilities in the U.S. and London.
