Volition's Nu.Q® Cancer Diagnostics Test Aims To Disrupt the Multi-Billion Dollar Liquid Biopsy Industry

Volition study shows rapid, low-cost, automated Nu.Q® Cancer test accurately detects human cancers at high specificity

HENDERSON, Nev., March 21, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ('Volition'), a multi-national epigenetics company, today announces the results of a study which shows that an automated Nu.Q® Cancer immunoassay test in development detected a range of 21 different cancers. This could potentially be used as a standalone pan-cancer test or, given its low false positive rate among healthy people, be licensed out for use in conjunction with other liquid biopsy technologies to improve accuracy.

Gael Forterre, Chief Commercial Officer at Volition, commented:

"Our mission since the company was incorporated was to help detect cancer early, with the aim of saving lives and improving outcomes.

"We are excited to publish this further validation of our Nu.Q® platform; it represents a potential opportunity to disrupt the $20 billion Total Annual Accessible Market for liquid biopsy for multi-cancer early detection in the U.S.¹.

"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.

"Volition's nucleosome assays can be run on existing automated chemiluminescence platforms worldwide and do not need new hardware. Our commercial strategy is to leverage this base to make Nu.Q® Cancer testing accessible to patients as widely as possible on existing platforms through licensing and partnership arrangements."

About the study

The study investigated a novel immunoassay method for the measurement of small amounts of cell-free nucleosomes in the blood of 229 cancer patients (including 70 early-stage cancer patients) and 150 healthy subjects. Findings published in the paper currently undergoing peer review and accessible on medRxiv, demonstrated the Nu.Q® Cancer test detected common fatal cancer diseases, including cancers of the lung, breast, prostate, colon and liver (overall AUC=86%) with very low false positive rates.

Dr Jake Micallef, Chief Scientific Officer at Volition, said:

"This is a breakthrough based on 15 years of development work by our scientific team at Volition. Presently, cancer is often diagnosed symptomatically at a late stage when it has spread to other parts of the body, is difficult to treat and can be deadly. Early detection of cancer at stage I or II is therefore a long-term goal in clinical practice. 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, helping to reduce unnecessary invasive biopsies, facilitating early treatment and improving patient outcomes."

Professor Léa Payen, Department of Biochemistry and Molecular Biology, Hospices Civils de Lyon (where a portion of the samples were independently processed) and co-author of the manuscript, said:

"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."

^{1.Data on file, Volition TAM model.}

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 to 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.

Media Enquiries:
Louise Batchelor, Volition, mediarelations@volition.com +44 (0)7557 774620

Investor Relations
Jeremy Feffer, LifeSci Advisors, jfeffer@lifesciadvisors.com +1-212-915-2568

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.

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SOURCE VolitionRx Limited