Volition Announces MARS Consortium Clinical Study Suggests Nu.Q® H3.1. Concentrations are Closely Associated with Sepsis and Organ Failure

Peer Reviewed Clinical Study for H3.1 Biomarker Published in Critical Care , /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announced the publication of a new clinical manuscript suggesting that the Nu.Q® H3.1 biomarker has the potential to inform clinical care in critically-ill Intensive Care Unit (ICU) patients in the assessment of sepsis, organ failure and subphenotypes. 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, Amsterdam and Senior Author of the paper added: "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 StudyThis 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 Belgium, with an innovation laboratory and office in the U.S. and an office in London. 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, [email protected], +44 (0)7557 774620 Investor Relations:Jeremy Feffer, LifeSci Advisors, [email protected] +1-212-915-2568 Safe Harbor Statement Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to, among other topics, the exercise of the milestone-linked warrants upon the achievement of such milestone events or otherwise prior to their expiration, Volition's expectations related to revenue opportunities and growth, the timing, completion, success and delivery of data from clinical studies, the timing of publications, the effectiveness of Volition's cost reduction measures, the effectiveness and availability of Volition's blood-based diagnostic, prognostic and disease monitoring tests, Volition's ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases as well as serving as a diagnostic, prognostic or disease monitoring tools for such diseases, and Volition's success in securing licensing and/or distribution agreements with third parties for its products. Volition's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including, without limitation, results of studies testing the efficacy of its tests. For instance, if Volition fails to develop and commercialize diagnostic, prognostic or disease monitoring products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition's failure to obtain necessary regulatory clearances or approvals to distribute and market future products; a failure by the marketplace to accept the products in Volition's development pipeline or any other diagnostic, prognostic or disease monitoring products Volition might develop; Volition's failure to secure adequate intellectual property protection; Volition will face fierce competition and Volition's intended products may become obsolete due to the highly competitive nature of the diagnostics and disease monitoring market and its rapid technological change; downturns in domestic and foreign economies; and other risks, including those identified in Volition's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances. Nucleosomics™, Capture-PCR™, Capture-Seq™ and Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners. Additionally, unless otherwise specified, all references to "$" refer to the legal currency of the United States of America. 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Volition Announces MARS Consortium Clinical Study Suggests Nu.Q® H3.1. Concentrations are Closely Associated with Sepsis and Organ Failure

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