VolitionRx’s Nu.Q® NETs Test Shows Promise in Study as Sepsis Severity Biomarker
VolitionRx Limited announced that the company’s Nu.Q® NETs test has been identified as a potential biomarker for assessing disease severity in patients with septic shock based upon the results of a new clinical study. The study featuring 150 patients suffering from septic shock, published in the Annals of Intensive Care aimed to assess nucleosome levels in septic shock patients using Volition’s automated nucleosome quantification assay, Nu.Q® NETs, and determine whether these levels correlate with patient mortality.
Nu.Q® NETs represents a new approach to sepsis diagnosis. It is a straightforward, cost-effective, and routine blood test designed to detect elevated levels of NETs (Neutrophil Extracellular Traps) by identifying the unique biomarker H3.1. NETs are composed of decondensed chromatin and play a vital role in the immune system by trapping and neutralizing bacteria, fungi, and viruses. However, when overproduced, they can lead to tissue damage, severe sepsis, organ failure, and even death.
The study found that nucleosome H3.1 levels showed a significant and consistent elevation in nucleosome levels at all time points in septic shock patients when compared to a control group. Importantly, a significant positive correlation was identified between nucleosome levels and multiple markers of disease severity, including organ failure and various scoring systems, IL-6 concentrations, and neutrophil count. These findings extended to mortality, where non-survivor patients displayed significantly higher nucleosome levels (both at day 1–2 and 3–4), with this association remaining significant even after multivariate analysis, particularly at the highest concentrations. Furthermore, early elevated nucleosome levels (day 1–2) were independently linked to 5-day mortality. Overall, nucleosome levels show strong associations with key immunological markers and, crucially, with mortality assessed at different time points. This indicates that nucleosome concentration holds promise as a potential biomarker for detecting a hyper-inflammatory phenotype when patients are admitted with sepsis.
Professor Guillaume Monneret, the leader of the trial, emphasized the significance of the study, stating, “This was the first study to investigate both nucleosomes and immunological parameters in septic shock. We saw a significant elevation of nucleosomes in septic shock patients. We also found a significant positive correlation between nucleosome levels and a range of disease severity indicators including SOFA, SAPS II, IL–6 concentrations, and neutrophil count. Additionally, significantly elevated nucleosome levels were independently associated with both five and 28-day mortality, even after adjusting for typical confounding factors such as age, severity scores, and IL-6.”
Sepsis is a pressing global health concern, responsible for an estimated 11 million deaths worldwide annually, accounting for 20% of all global fatalities. Mortality associated with a diagnosis of septic shock is between 20-50% in patients receiving medical intervention.