Large clinical study establishes Nu.Q® NETs H3.1 as an independent predictor of 28-day mortality in sepsis
Rhea-AI Summary
VolitionRx (NYSE AMERICAN: VNRX) has announced significant results from a large-scale study of its Nu.Q®NETs H3.1 biomarker in sepsis patients. The study, analyzing plasma samples from 971 patients with sepsis and septic shock, demonstrates that the biomarker can independently predict 28-day mortality and need for renal replacement therapy.
The research reveals higher biomarker levels in septic shock compared to sepsis patients, showing a dose-response relationship with acute kidney injury severity. The study suggests Nu.Q® NETs H3.1's potential for risk stratification and early intervention in critically ill sepsis patients.
The company is currently engaged in commercial discussions with major diagnostic industry players, particularly focusing on the sepsis market. The technology aims to provide simple, cost-effective blood tests for disease diagnosis and monitoring in both humans and animals.
Positive
- Large-scale validation study with 971 patients demonstrates Nu.Q®NETs H3.1's effectiveness as mortality predictor
- Active commercial discussions ongoing with major diagnostic industry players
- Technology shows potential for early risk stratification in sepsis patients
Negative
- Study results still undergoing peer review
- Commercial partnerships not yet finalized
News Market Reaction
On the day this news was published, VNRX gained 2.88%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Findings published in the paper currently undergoing peer review and accessible on MEDRXIV, demonstrate Nu.Q® NETs H3.1 is a promising novel biomarker for early mortality and organ dysfunction in sepsis, with significantly higher levels found in septic shock than sepsis patients and a clear dose-response relationship with acute kidney injury severity. The findings indicate Nu.Q® NETs H3.1's potential clinical utility for risk stratification and early intervention in critically ill patients presenting with sepsis.
The study is a secondary analysis of circulating H3.1 nucleosomes in plasma samples collected from 971 patients with sepsis and septic shock who participated in the multicentre, randomised, bifactorial, prospective SISPCT trial (Clinicaltrials.gov identifier, NCT00832039).
Professor Michael Bauer, Chair of the Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital,
"Our study establishes H3.1 nucleosomes as a biomarker delineating organ dysfunction in sepsis, particularly for early mortality and RRT. The clear stratification of risk and independence from conventional markers suggests clinical utility.
"Being able to predict a sepsis patient's clinical course early, by using Nu.Q® NETs in clinical practice, could significantly enhance sepsis management, enabling physicians more time to intervene and improve patient outcomes."
Dr Andrew Retter, Chief Medical Officer at Volition said:
"We are excited to report the findings of this large-scale independent clinical study, the culmination of many years work. Nu.Q® NETs, Volition's nucleosome quantification technology, is a simple, low-cost, accessible test to detect diseases associated with NETosis. Although NETs play a critical role in our normal immune response, elevated levels of NETs can lead to tissue damage and in severe cases, sepsis, organ failure, and death. These findings advance our understanding of nucleosome biology in critical illness and help inform future therapeutic strategies.
Introducing Nu.Q® NETs into hospitals could lead to new ways of treating sepsis, improve patient survival and the quality of life of survivors."
Volition is currently advancing several active commercial discussions with significant players in the diagnostic space, including large markets such as sepsis; the findings from the latest study support this ongoing licensing process. Volition is developing simple, easy-to-use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases in both humans and animals.
For more information about Volition's technology go to: www.volition.com
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 diagnose and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early diagnosis and monitoring have the potential not only to prolong the life of patients but also 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/Debra Daglish, Volition, mediarelations@volition.com +44 (0)7557 774620
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, 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 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 press 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™ 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.
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SOURCE VolitionRx Limited
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