VolitionRx Limited (NYSE American: VNRX) announced the publication of a peer-reviewed study in Critical Care Medicine finding that its Nu.Q NETs H3.1 biomarker is an independent predictor of 28-day mortality and need for renal replacement therapy in sepsis and septic shock patients.

The study, a secondary analysis of the SISPCT randomized controlled trial, found significantly higher H3.1 nucleosome levels in septic shock patients compared to those with sepsis, and identified a dose-response relationship with acute kidney injury severity. The authors concluded the biomarker has potential clinical utility for risk stratification and early intervention in critically ill patients.

Critical Care Medicine also published an accompanying editorial stating that "the clinical value of H3.1 may lie less in its ability to predict outcomes than in its potential to identify a biologically distinct subgroup of patients with NET-mediated organ injury."

Professor Michael Bauer, Chair of the Department of Anesthesiology and Intensive Care Medicine at Jena University Hospital in Germany and co-author of the paper, said the findings establish H3.1 nucleosomes as a biomarker for organ dysfunction in sepsis, noting that early prediction of a patient's clinical course "could significantly enhance sepsis management."

Volition said it is engaged in commercial discussions with diagnostic companies and that the publication supports its ongoing licensing process. The company cited a total addressable market of $2.8 billion for the sepsis segment, based on its own internal model.

According to data cited in the press release from The Lancet Global Health, there were approximately 166 million sepsis cases worldwide in 2021, resulting in 21.4 million deaths.

Volition is a multinational epigenetics company with research and development operations in Belgium and additional offices in the U.S., London, and Singapore.