Henderson, Nevada, December 10, 2024 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-national epigenetics company, today announced the results of a large-scale study which shows that its Nu.Q® Cancer Test differentiated between malignant and benign pulmonary nodules, found by Low Dose CT (LDCT) scan, in patients suspected of lung cancer.
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 92% and a Positive Predictive Value of 89% in identifying cancerous nodules when used in combination with LDCT screening.
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 Taiwan’s National Lung Cancer Screening Program.”
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
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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 Belgium, with an innovation laboratory and office in the U.S. and additional offices in London and Singapore.
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
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.
Released December 10, 2024
