Study shows Nu.Q® Lung Cancer Test differentiated malignant and benign nodules found by Low Dose CT screening
VolitionRx (NYSE AMERICAN: VNRX) announced results from an 800-patient study showing its Nu.Q® Cancer Test can differentiate between malignant and benign pulmonary nodules found by Low Dose CT (LDCT) scan in lung cancer screening. The study, led by Professor Jin-Shing Chen at National Taiwan University Hospital, revealed that a panel of two Nu.Q® nucleosome quantification assays achieved 92% diagnostic sensitivity and 89% Positive Predictive Value when combined with LDCT screening.
A 500-patient validation study in a real-world setting is planned to begin this year, with completion expected in 2025. If successful, the test could be included in Taiwan's National Lung Cancer Screening Program, potentially reducing unnecessary biopsies and surgeries for patients with benign nodules.
VolitionRx (NYSE AMERICAN: VNRX) ha annunciato i risultati di uno studio su 800 pazienti che mostra come il suo Nu.Q® Cancer Test possa distinguere tra noduli polmonari maligni e benigni identificati tramite scansione CT a bassa dose (LDCT) per lo screening del cancro ai polmoni. Lo studio, condotto dal Professor Jin-Shing Chen presso il National Taiwan University Hospital, ha rivelato che un pannello di due test di quantificazione dei nucleosomi Nu.Q® ha raggiunto una sensitivity diagnostica del 92% e un valore predittivo positivo dell'89% quando combinato con lo screening LDCT.
È previsto l'avvio di uno studio di validazione su 500 pazienti in un contesto reale entro quest'anno, con completamento atteso nel 2025. Se avrà successo, il test potrebbe essere incluso nel Programma Nazionale di Screening per il Cancro ai Polmoni di Taiwan, riducendo potenzialmente biopsie e interventi chirurgici non necessari per pazienti con noduli benigni.
VolitionRx (NYSE AMERICAN: VNRX) anunció los resultados de un estudio con 800 pacientes que muestra que su Nu.Q® Cancer Test puede diferenciar entre nódulos pulmonares malignos y benignos encontrados mediante un escaneo CT de baja dosis (LDCT) en el cribado de cáncer de pulmón. El estudio, dirigido por el Profesor Jin-Shing Chen en el Hospital Universitario Nacional de Taiwán, reveló que un panel de dos ensayos de cuantificación de nucleosomas Nu.Q® logró una sensibilidad diagnóstica del 92% y un valor predictivo positivo del 89% cuando se combina con el cribado LDCT.
Se planea un estudio de validación con 500 pacientes en un entorno real que comenzará este año, con finalización prevista para 2025. Si tiene éxito, la prueba podría incluirse en el Programa Nacional de Cribado del Cáncer de Pulmón de Taiwán, lo que podría reducir biopsias y cirugías innecesarias para pacientes con nódulos benignos.
VolitionRx (NYSE AMERICAN: VNRX)는 800명 환자를 대상으로 한 연구 결과를 발표했으며, Nu.Q® 암 검사를 통해 폐암 검진에서 저선량 CT(LDCT) 스캔으로 발견된 악성 및 양성 폐결절을 구별할 수 있음을 보여줍니다. 이 연구는 국립 타이완 대학교 병원 Jin-Shing Chen 교수의 주도로 진행되었으며, 두 가지 Nu.Q® 핵소체 정량 분석 패널이 LDCT 스크리닝과 결합 시 92%의 진단 민감도와 89%의 양성 예측 가치를 달성했음을 밝혔습니다.
올해 시작될 실제 환경에서의 500명 환자 검증 연구가 계획되어 있으며, 2025년 완료가 예상됩니다. 성공할 경우, 이 검사는 대만의 국가 폐암 검진 프로그램에 포함될 수 있으며, 양성 결절을 가진 환자들에게 불필요한 생검 및 수술을 줄일 수 있습니다.
VolitionRx (NYSE AMERICAN: VNRX) a annoncé les résultats d'une étude portant sur 800 patients montrant que son Nu.Q® Cancer Test peut différencier les nodules pulmonaires malins et bénins détectés par un scanner CT à faible dose (LDCT) lors du dépistage du cancer du poumon. L'étude, dirigée par le Professeur Jin-Shing Chen à l'Hôpital Universitaire National de Taïwan, a révélé qu'un panel de deux tests de quantification de nucléosomes Nu.Q® a atteint une sensibilité diagnostique de 92% et un valeur prédictive positive de 89% lorsqu'il est combiné avec le dépistage LDCT.
Une étude de validation sur 500 patients dans un environnement réel est prévue pour commencer cette année, avec une achèvement attendu en 2025. Si cela réussit, le test pourrait être inclus dans le Programme National de Dépistage du Cancer du Poumon de Taïwan, réduisant potentiellement les biopsies et les chirurgies inutiles pour les patients présentant des nodules bénins.
VolitionRx (NYSE AMERICAN: VNRX) hat Ergebnisse einer Studie mit 800 Patienten bekannt gegeben, die zeigt, dass der Nu.Q® Krebs-Test zwischen bösartigen und gutartigen Lungenknoten, die durch Low-Dose-CT (LDCT)-Scans bei der Lungenkrebsfrüherkennung gefunden wurden, unterscheiden kann. Die Studie, die von Professor Jin-Shing Chen am National Taiwan University Hospital geleitet wurde, ergab, dass eine Kombination aus zwei Nu.Q® Nukleosomenquantifizierungs-Assays eine 92% diagnostische Sensitivität und einen 89% positiven prädiktiven Wert in Verbindung mit dem LDCT-Screening erreichte.
In diesem Jahr ist eine Validierungsstudie mit 500 Patienten in einer realen Umgebung geplant, deren Abschluss für 2025 erwartet wird. Bei Erfolg könnte der Test in das nationale Lungenkrebsfrüherkennungsprogramm Taiwans aufgenommen werden, was potenziell unnötige Biopsien und Operationen für Patienten mit gutartigen Knoten reduzieren könnte.
- High diagnostic sensitivity (92%) and Positive Predictive Value (89%) in identifying cancerous nodules
- Potential inclusion in Taiwan's National Lung Cancer Screening Program
- Technology could reduce unnecessary biopsies and surgeries, leading to cost savings
- Validation study results not yet available
- Study findings still undergoing peer review
Insights
The 800-patient prospective study was led by Professor Jin-Shing Chen and his team at National Taiwan University Hospital.
Findings published in a paper that is currently undergoing peer review and accessible on MedRXIV, conclude that a panel of two Nu.Q® nucleosome quantification assays (H3.1 and H3K27Me3) showed a diagnostic sensitivity of
Professor Chen, Department Chief, Department of Surgery, National Taiwan University Hospital, said:
"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.
"Our findings suggest that the Nu.Q® Cancer blood test could provide an accurate method for classifying and identifying pulmonary nodules across different Lung-RADS categories, the standard for lung cancer screening CT reporting and management recommendations, including small nodules.
"Our team will now embark on a 500-patient, prospective validation study, taking place in a real-world setting at the National Taiwan University Hospital and National Taiwan University Hospital Cancer Centre. The validation study is set to begin this year and due for completion in 2025, potentially leading to the inclusion of the Nu.Q® Cancer test in
Jasmine Kway, Chief Executive Officer of Singapore Volition, said:
"There is an unmet clinical need for accurate non-invasive tests to differentiate between malignant and benign nodules in combination with LDCT screening.
"The study conducted by the National Taiwan University Hospital showed that our Nu.Q® biomarkers exhibited high sensitivity and accuracy. These biomarkers demonstrated a high Positive Predictive Value (PPV), which we believe can aid in the precise diagnosis of lung cancer in patients.
"We believe our groundbreaking Nu.Q® Cancer test could support physicians with clinical decision-making following LDCT. It could enable them to identify 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."
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.
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SOURCE VolitionRx Limited
FAQ
What were the results of VolitionRx's (VNRX) Nu.Q® Lung Cancer Test study in 2024?
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