Volition Announces First Patient Enrolled in NTU Hospital's Prospective Validation Study of Nu.Q® Lung Cancer Test
VolitionRx (NYSE AMERICAN: VNRX) has announced the enrollment of its first patient in a clinical validation study for its Nu.Q® Cancer technology at National Taiwan University Hospital. The study aims to evaluate the technology's ability to differentiate between malignant and benign pulmonary nodules in patients undergoing low-dose computed tomography (LDCT) screening for lung cancer.
The 500-patient prospective validation study follows promising results from a previous study published on March 7th, 2025, which showed Nu.Q® Cancer's high sensitivity in identifying malignant nodules. The current study is expected to be completed by the end of 2025.
If successful, the Nu.Q® test could be integrated into national lung cancer screening programs, potentially reducing false positives and unnecessary invasive procedures. The blood-based test aims to support physicians in clinical decision-making by identifying high-risk patients and those who might avoid unnecessary biopsies.
VolitionRx (NYSE AMERICAN: VNRX) ha annunciato l'arruolamento del suo primo paziente in uno studio di validazione clinica per la sua tecnologia Nu.Q® Cancer presso l'Ospedale Nazionale Universitario di Taiwan. Lo studio mira a valutare la capacità della tecnologia di differenziare tra noduli polmonari maligni e benigni in pazienti sottoposti a screening con tomografia computerizzata a bassa dose (LDCT) per il cancro ai polmoni.
Lo studio di validazione prospettico, che coinvolge 500 pazienti, segue risultati promettenti da uno studio precedente pubblicato il 7 marzo 2025, che ha mostrato l'alta sensibilità di Nu.Q® Cancer nell'identificare noduli maligni. Si prevede che lo studio attuale venga completato entro la fine del 2025.
Se avrà successo, il test Nu.Q® potrebbe essere integrato nei programmi nazionali di screening per il cancro ai polmoni, riducendo potenzialmente i falsi positivi e le procedure invasive non necessarie. Il test basato sul sangue mira a supportare i medici nella decisione clinica identificando pazienti ad alto rischio e quelli che potrebbero evitare biopsie non necessarie.
VolitionRx (NYSE AMERICAN: VNRX) ha anunciado la inscripción de su primer paciente en un estudio de validación clínica para su tecnología Nu.Q® Cancer en el Hospital Universitario Nacional de Taiwán. El estudio tiene como objetivo evaluar la capacidad de la tecnología para diferenciar entre nódulos pulmonares malignos y benignos en pacientes que se someten a un cribado de tomografía computarizada de baja dosis (LDCT) para el cáncer de pulmón.
El estudio de validación prospectivo de 500 pacientes sigue a resultados prometedores de un estudio anterior publicado el 7 de marzo de 2025, que mostró la alta sensibilidad de Nu.Q® Cancer para identificar nódulos malignos. Se espera que el estudio actual se complete a finales de 2025.
Si tiene éxito, la prueba Nu.Q® podría integrarse en los programas nacionales de cribado del cáncer de pulmón, lo que podría reducir los falsos positivos y los procedimientos invasivos innecesarios. La prueba basada en sangre tiene como objetivo apoyar a los médicos en la toma de decisiones clínicas al identificar a pacientes de alto riesgo y aquellos que podrían evitar biopsias innecesarias.
VolitionRx (NYSE AMERICAN: VNRX)는 대만 국립대학교 병원에서 Nu.Q® Cancer 기술에 대한 임상 검증 연구에 첫 번째 환자를 등록했다고 발표했습니다. 이 연구는 폐암을 위한 저선량 컴퓨터 단층촬영(LDCT) 검사를 받는 환자에서 악성 및 양성 폐 결절을 구별하는 기술의 능력을 평가하는 것을 목표로 합니다.
500명의 환자를 대상으로 한 이 전향적 검증 연구는 2025년 3월 7일에 발표된 이전 연구의 유망한 결과를 따릅니다. 이 연구는 악성 결절을 식별하는 데 있어 Nu.Q® Cancer의 높은 민감도를 보여주었습니다. 현재 연구는 2025년 말까지 완료될 것으로 예상됩니다.
성공할 경우, Nu.Q® 테스트는 국가 폐암 검진 프로그램에 통합될 수 있으며, 이는 잘못된 양성 결과와 불필요한 침습적 절차를 줄일 수 있습니다. 혈액 기반 테스트는 높은 위험 환자와 불필요한 생검을 피할 수 있는 환자를 식별하여 의사의 임상 결정 지원을 목표로 합니다.
VolitionRx (NYSE AMERICAN: VNRX) a annoncé l'inscription de son premier patient dans une étude de validation clinique pour sa technologie Nu.Q® Cancer à l'Hôpital Universitaire National de Taïwan. L'étude vise à évaluer la capacité de la technologie à différencier les nodules pulmonaires malins et bénins chez les patients subissant un dépistage par tomodensitométrie à faible dose (LDCT) pour le cancer du poumon.
L'étude de validation prospective de 500 patients fait suite à des résultats prometteurs d'une étude précédente publiée le 7 mars 2025, qui a montré la haute sensibilité de Nu.Q® Cancer dans l'identification des nodules malins. L'étude actuelle devrait être achevée d'ici la fin de 2025.
Si elle réussit, le test Nu.Q® pourrait être intégré dans les programmes nationaux de dépistage du cancer du poumon, réduisant potentiellement les faux positifs et les procédures invasives inutiles. Le test basé sur le sang vise à soutenir les médecins dans la prise de décision clinique en identifiant les patients à haut risque et ceux qui pourraient éviter des biopsies inutiles.
VolitionRx (NYSE AMERICAN: VNRX) hat die Einschreibung seines ersten Patienten in eine klinische Validierungsstudie für die Nu.Q® Cancer-Technologie am Nationalen Taiwan-Universitätskrankenhaus bekannt gegeben. Die Studie zielt darauf ab, die Fähigkeit der Technologie zu bewerten, zwischen bösartigen und gutartigen Lungenknoten bei Patienten zu unterscheiden, die sich einem Screening mit Niedrigdosis-Computertomographie (LDCT) auf Lungenkrebs unterziehen.
Die prospektive Validierungsstudie mit 500 Patienten folgt vielversprechenden Ergebnissen aus einer früheren Studie, die am 7. März 2025 veröffentlicht wurde und die hohe Sensitivität von Nu.Q® Cancer bei der Identifizierung bösartiger Knoten zeigte. Es wird erwartet, dass die aktuelle Studie bis Ende 2025 abgeschlossen sein wird.
Im Erfolgsfall könnte der Nu.Q®-Test in nationale Programme zur Lungenkrebsfrüherkennung integriert werden, was potenziell falsch-positive Ergebnisse und unnötige invasive Eingriffe reduzieren könnte. Der blutbasierte Test zielt darauf ab, Ärzte bei der klinischen Entscheidungsfindung zu unterstützen, indem er hochriskante Patienten und solche identifiziert, die unnötige Biopsien vermeiden könnten.
- Previous study demonstrated high sensitivity in identifying malignant nodules
- Potential to reduce unnecessary biopsies and surgeries
- Blood-based test could complement existing LDCT screening programs
- Large market opportunity if adopted in national screening programs
- Study results not expected until end of 2025
- No guarantee of successful validation or market adoption
- Requires additional clinical validation before potential commercialization
Insights
Volition's announcement of first patient enrollment in a prospective validation study for its Nu.Q® Lung Cancer blood test represents a meaningful clinical development milestone. This 500-patient study at National Taiwan University Hospital aims to validate whether their proprietary epigenetic test can differentiate between malignant and benign pulmonary nodules found during LDCT screening.
The company is addressing a significant clinical challenge with LDCT screening — while effective at detecting nodules, it produces numerous false positives leading to unnecessary invasive procedures. A recently published study suggests Nu.Q® can identify malignant nodules with high sensitivity, including small ones that are typically difficult to characterize.
If validated in this larger cohort, Volition's blood test could potentially be incorporated into national lung cancer screening programs, starting with Taiwan. This represents a substantial market opportunity given lung cancer's position as a leading cause of cancer mortality globally.
The aggressive timeline targeting completion by end of 2025 suggests strong institutional support for this program. However, investors should recognize that while first patient enrollment is positive progress, numerous steps remain between validation and potential commercialization, including regulatory approval pathways that weren't addressed in this announcement.
Volition's first patient enrollment in this 500-patient validation study represents incremental progress for its Nu.Q® diagnostic platform in the competitive cancer detection market. The clinical problem being addressed is substantial — LDCT screening for lung cancer suffers from high false positive rates, leading to unnecessary invasive procedures with associated costs and complications.
From a market perspective, a blood-based test that could reliably differentiate between malignant and benign nodules would find immediate clinical utility within established screening programs. The company is smartly positioning this as complementary to LDCT rather than replacing imaging, which aligns with how diagnostic tests are typically adopted into clinical workflows.
What's particularly noteworthy is the potential inclusion in national screening programs, which would provide a clear commercialization pathway with predictable volumes. Taiwan could serve as the initial market, potentially followed by other countries with established lung cancer screening initiatives.
However, this announcement represents early-stage clinical validation, with the full 500-patient study not expected to complete until late 2025. Even with positive results, regulatory approval and clinical adoption would still take additional time. For a company with Volition's market capitalization (
Published study shows Nu.Q® Lung Cancer Test differentiated malignant and benign nodules found by Low Dose CT screening.
The study is expected to be completed by the end of 2025
Professor Jin-Shing Chen, Department Chief, Department of Surgery, National Taiwan University Hospital, said:
"We are delighted to have recruited the first patient into our 500-patient prospective validation study.
"Lung cancer is a leading cause of cancer-related deaths globally. LDCT is the gold standard for lung cancer screening and has been instrumental in reducing mortality in high-risk patients. However, it is highly sensitive and can result in a large number of false positives and over-diagnosis, meaning patients with benign nodules face unnecessary and invasive biopsy and surgery.
"Results from our previous study, published on March 7th 2025 in the 2nd Edition of Cancer Epigenetic Biomarkers, indicate that Nu.Q® Cancer can accurately identify malignant nodules, including small ones, with high sensitivity.
"This validation study is expected to be completed this year; if the findings align with previous results, the Nu.Q® test may be considered for use in combination with any national lung cancer screening programs, such as in
"More accurate screening could lead to greater uptake of screening by patients and greater adoption of screening programs by governments. This should, in turn, lead to lung cancer being diagnosed earlier, saving many, many lives."
Jasmine Kway, Chief Executive Officer of Singapore Volition, said:
"First patient enrolment is an important milestone and the results of this study could lead to the inclusion of our groundbreaking Nu.Q® Cancer test in national lung cancer screening programs.
"The Nu.Q® Cancer test could support physicians with clinical decision-making following LDCT by identifying the patients at highest risk and whose nodules are more likely to be cancerous, while potentially identifying patients who present with a low risk of lung cancer for follow-up, to avoid unnecessary biopsy.
"A blood-based test that can help distinguish between cancerous and non-cancerous nodules would be tremendously valuable in clinical practice and a strong addition to any lung cancer screening program."
About
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About Volition
Volition is a multi-national epigenetics 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.
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.
Media Enquiries:
Louise Batchelor, Volition, mediarelations@volition.com +44 (0)7557 774620
Investor Relations
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SOURCE VolitionRx Limited
FAQ
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