Volition has announced significant progress in the clinical validation of its proprietary Nu.Q® Cancer technology, with two major developments that could transform early cancer detection and screening programs.
First Patient Enrolled in Lung Cancer Nodule Differentiation Study
VolitionRx Limited (NYSE AMERICAN: VNRX) has enrolled the first patient in a prospective validation study evaluating its Nu.Q® Cancer technology for distinguishing between malignant and benign pulmonary nodules in patients undergoing low-dose computed tomography (LDCT) screening for lung cancer.
The 500-patient study, conducted in collaboration with National Taiwan University Hospital, aims to address a critical challenge in lung cancer screening. While LDCT is the gold standard for early detection, its high sensitivity often results in false positives and over-diagnosis, leading to unnecessary invasive procedures.
Professor Jin-Shing Chen, Department Chief of Surgery at National Taiwan University Hospital, highlighted the potential impact: "Results from our previous study, published on March 7th, 2025, indicate that Nu.Q® Cancer can accurately identify malignant nodules, including small ones, with high sensitivity."
The validation study is expected to be completed by the end of 2025. If successful, the Nu.Q® test could be incorporated into national lung cancer screening programs, potentially increasing screening uptake and saving lives through earlier diagnosis.
"First patient enrollment is an important milestone," said Jasmine Kway, Chief Executive Officer of Singapore Volition. "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."
Breakthrough in Pan-Cancer Detection
In a separate development, Volition has announced results from a study showing that an automated Nu.Q® Cancer immunoassay test in development successfully detected a range of 21 different cancers with high accuracy.
The study, currently undergoing peer review and available on medRxiv, investigated a novel immunoassay method for measuring small amounts of cell-free nucleosomes in blood samples from 229 cancer patients (including 70 with early-stage cancer) and 150 healthy subjects.
The test demonstrated an overall AUC (Area Under the Curve) of 86% in detecting common fatal cancers, including lung, breast, prostate, colon, and liver cancers, with very low false positive rates.
"This is a breakthrough based on 15 years of development work by our scientific team at Volition," said Dr. Jake Micallef, Chief Scientific Officer at Volition. "The accuracy, low-cost and routine nature of the Nu.Q® Cancer test means it may be useful, alongside current cancer screening methods, for detecting cancer before symptoms become apparent."
Commercial Strategy and Market Potential
Volition is positioning its Nu.Q® technology to disrupt the liquid biopsy industry, which represents a $20 billion Total Annual Accessible Market in the U.S. alone.
Gael Forterre, Chief Commercial Officer at Volition, outlined the company's strategy: "We are in active discussions regarding our cancer portfolio with several large diagnostic and liquid biopsy companies, with the goal of signing multiple licensing agreements this year, including milestone payments in addition to ongoing revenue."
A key advantage of Volition's approach is that its nucleosome assays can run on existing automated chemiluminescence platforms worldwide without requiring new hardware. This could accelerate adoption and make the technology widely accessible through licensing and partnership arrangements.
Professor Léa Payen from the Department of Biochemistry and Molecular Biology at Hospices Civils de Lyon, who co-authored the pan-cancer study, noted: "Circulating nucleosome levels show great promise as clinically useful biomarkers in oncology. We are working with Volition to advance the use of nucleosome measurements not only in early cancer detection but also in the management of cancer patients, particularly in the detection of Minimal Residual Disease for assessment of treatment efficacy."
About Volition's Nu.Q® Technology
Volition's Nu.Q® technology is based on the science of epigenetics, focusing on nucleosomes—structures consisting of DNA wrapped around histone proteins. The company's proprietary tests measure and analyze these nucleosomes in blood samples to detect cancer and other diseases.
The technology has potential applications across the cancer care continuum, from early detection and screening to treatment monitoring and minimal residual disease assessment.
As a multi-national epigenetics company, Volition conducts its research and development primarily in Belgium, with additional facilities in the U.S. and London. The company's mission is to save lives and improve outcomes through earlier detection and better monitoring of life-altering diseases.
