Large clinical study establishes Nu.Q® NETs H3.1 as an independent predictor of 28-day mortality in sepsis
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.
VolitionRx (NYSE AMERICAN: VNRX) ha annunciato risultati significativi da uno studio su larga scala del suo biomarker Nu.Q®NETs H3.1 nei pazienti con sepsi. Lo studio, che ha analizzato campioni di plasma di 971 pazienti con sepsi e shock settico, dimostra che il biomarker può prevedere indipendentemente la mortalità a 28 giorni e la necessità di terapia di sostituzione renale.
La ricerca rivela livelli più elevati del biomarker nei casi di shock settico rispetto ai pazienti con sepsi, mostrando una relazione dose-risposta con la gravità dell'infortunio renale acuto. Lo studio suggerisce il potenziale di Nu.Q® NETs H3.1 per la stratificazione del rischio e l'intervento precoce nei pazienti critici con sepsi.
L'azienda è attualmente impegnata in discussioni commerciali con i principali attori dell'industria diagnostica, concentrandosi in particolare sul mercato della sepsi. La tecnologia mira a fornire test sanguigni semplici ed economici per la diagnosi e il monitoraggio delle malattie sia negli esseri umani che negli animali.
VolitionRx (NYSE AMERICAN: VNRX) ha anunciado resultados significativos de un estudio a gran escala de su biomarcador Nu.Q®NETs H3.1 en pacientes con sepsis. El estudio, que analiza muestras de plasma de 971 pacientes con sepsis y shock séptico, demuestra que el biomarcador puede predecir de forma independiente la mortalidad a 28 días y la necesidad de terapia de reemplazo renal.
La investigación revela niveles más altos del biomarcador en el shock séptico en comparación con los pacientes con sepsis, mostrando una relación dosis-respuesta con la gravedad de la lesión renal aguda. El estudio sugiere el potencial de Nu.Q® NETs H3.1 para la estratificación del riesgo y la intervención temprana en pacientes críticos con sepsis.
La empresa está actualmente involucrada en discusiones comerciales con importantes actores de la industria diagnóstica, centrándose en particular en el mercado de la sepsis. La tecnología tiene como objetivo proporcionar pruebas de sangre simples y rentables para el diagnóstico y el monitoreo de enfermedades tanto en humanos como en animales.
VolitionRx (NYSE AMERICAN: VNRX)는 패혈증 환자에서 Nu.Q®NETs H3.1 바이오마커에 대한 대규모 연구의 중요한 결과를 발표했습니다. 이 연구는 패혈증 및 패혈성 쇼크가 있는 971명의 환자에서 혈장 샘플을 분석하여 바이오마커가 28일 사망률과 신장 대체 요법의 필요성을 독립적으로 예측할 수 있음을 보여줍니다.
연구 결과, 패혈성 쇼크에서 바이오마커 수준이 패혈증 환자에 비해 더 높고, 급성 신장 손상 정도와의 용량 반응 관계를 나타냅니다. 이 연구는 Nu.Q® NETs H3.1이 위중한 패혈증 환자의 위험 계층화 및 조기 개입에 미치는 잠재력을 시사합니다.
회사는 현재 주요 진단 산업 업체들과 상업적 논의에 참여하고 있으며, 특히 패혈증 시장에 중점을 두고 있습니다. 이 기술은 인체 및 동물 모두의 질병 진단 및 모니터링을 위한 간단하고 비용 효율적인 혈액 검사를 제공하는 것을 목표로 하고 있습니다.
VolitionRx (NYSE AMERICAN: VNRX) a annoncé des résultats significatifs d'une étude à grande échelle de son biomarqueur Nu.Q®NETs H3.1 chez des patients septicémiques. L'étude, qui analyse des échantillons de plasma de 971 patients atteints de sepsis et de choc septique, démontre que le biomarqueur peut prédire de manière indépendante la mortalité à 28 jours et le besoin de thérapie de remplacement rénal.
La recherche révèle des niveaux de biomarqueurs plus élevés dans le cas de choc septique par rapport aux patients atteints de sepsis, montrant une relation dose-réponse avec la gravité des lésions rénales aigües. L'étude suggère le potentiel de Nu.Q® NETs H3.1 pour la stratification des risques et l'intervention précoce chez les patients gravement malades atteints de sepsis.
L'entreprise est actuellement engagée dans des discussions commerciales avec des acteurs majeurs de l'industrie diagnostique, en se concentrant particulièrement sur le marché de la sepsis. La technologie vise à fournir des tests sanguins simples et rentables pour le diagnostic et le suivi des maladies chez les humains et les animaux.
VolitionRx (NYSE AMERICAN: VNRX) hat bedeutende Ergebnisse aus einer umfassenden Studie zu seinem Nu.Q®NETs H3.1 Biomarker bei Patienten mit Sepsis bekannt gegeben. Die Studie, die Plasmaproben von 971 Patienten mit Sepsis und septischem Schock analysiert, zeigt, dass der Biomarker unabhängig die 28-Tage-Mortalität und den Bedarf an Nierenersatztherapie vorhersagen kann.
Die Forschung zeigt höhere Biomarkerwerte bei septischem Schock im Vergleich zu Sepsis-Patienten und zeigt eine Dosis-Wirkungs-Beziehung mit der Schwere der akuten Nierenschädigung. Die Studie legt nahe, dass das Nu.Q® NETs H3.1 Potenzial für die Risikostratifizierung und die frühzeitige Intervention bei kritisch kranken Sepsis-Patienten hat.
Das Unternehmen führt derzeit kommerzielle Gespräche mit bedeutenden Akteuren der Diagnostikbranche, insbesondere mit Fokus auf den Sepsis-Markt. Die Technologie zielt darauf ab, einfache und kostengünstige Bluttests zur Diagnose und Überwachung von Krankheiten sowohl bei Menschen als auch bei Tieren bereitzustellen.
- 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
- Study results still undergoing peer review
- Commercial partnerships not yet finalized
Insights
The publication of this large-scale clinical study (n=971) marks a significant milestone for Volition's Nu.Q® NETs H3.1 biomarker. The results demonstrate two important clinical applications: prediction of 28-day mortality and identification of patients requiring renal replacement therapy in sepsis cases.
The study's strengths are particularly noteworthy: it's multi-centered, randomized and prospective, providing robust Level 1 evidence. The biomarker shows a clear dose-response relationship with acute kidney injury severity, which is essential for clinical validity. The independence from conventional markers suggests it provides unique, complementary information to existing diagnostic tools.
From a clinical utility perspective, early risk stratification in sepsis is important as mortality rates increase significantly with delayed intervention. Current sepsis biomarkers have limitations in predicting outcomes and organ dysfunction. Nu.Q® NETs' ability to identify high-risk patients early could enable more aggressive interventions and closer monitoring of at-risk individuals.
The commercial implications are substantial. The global sepsis diagnostics market is projected to reach several billion dollars and there's a critical need for better prognostic tools. Volition's mention of 'active commercial discussions with significant players' suggests potential licensing deals or partnerships could be forthcoming. The test's described attributes - simple, low-cost and accessible - align well with market demands for point-of-care diagnostics.
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
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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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