Volition Announces First Patient Enrolled in NTU Hospital's Prospective Validation Study of Nu.Q® Lung Cancer Test

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

HENDERSON, Nev., March 11, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, announces first patient enrollment in a clinical study evaluating the company's proprietary 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 study, in collaboration with National Taiwan University Hospital, is entitled "Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation." Details of the validation study can be found at https://www.clinicaltrials.gov/.

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 7^th 2025 in the 2^nd 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 Taiwan.

"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 Taiwan

The population of Taiwan is around 23.5 million people and it was estimated in 2020 that approximately 2.7¹ million people smoked, a known risk factor for lung cancer.

¹ https://gsthr.org/countries/profile/twn/1/

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 Belgium, with an innovation laboratory and office in the U.S. and London.  

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, [email protected] +44 (0)7557 774620

Investor Relations

Jeremy Feffer, LifeSci Advisors, [email protected], +1-212-915-2568

SOURCE VolitionRx Limited