VolitionRx Limited Announces the First Sale of the Nu.Q® Cancer Assays for Clinical Certification in Preparation for Routine Clinical Use

Rhea-AI Summary

VolitionRx (NYSE AMERICAN: VNRX) announced the first commercial sale of its Nu.Q® Cancer assays to Hospices Civils de Lyon in Lyon, France on November 25, 2025.

The order is to complete internal clinical certification ahead of introducing Nu.Q® into routine clinical practice for cancer management, with cited evidence that methylated nucleosome biomarkers at non‑small cell lung cancer (NSCLC) diagnosis correlate with survival and progression‑free survival and can help identify patients who may benefit from curative care.

Company executives described the sale as a commercialization milestone and a step toward clinical use and licensing of Nu.Q® in human cancer.

Insights

Clinical-commercial analyst

First institutional sale to Hospices Civils de Lyon positions Nu.Q® for near-term clinical certification and routine use.

Volition secured an initial order of its Nu.Q® Cancer assays from Hospices Civils de Lyon on Nov 25, 2025, marking a move from research validation toward clinical certification and routine deployment. This sale is a commercial validation step: an accredited European cancer centre will complete internal certification before using the test clinically, which directly links the product to real-world diagnostic workflows rather than purely academic study.

Key dependencies and risks include the outcome of the internal certification process, the reproducibility of the published biomarker findings (citations from 2023–2025 are cited), and the operational integration in hospital pathways. The announcement presents clinical utility claims about prognostication and treatment-selection support; those claims rest on the referenced studies and the hospital’s internal verification rather than new regulatory approvals.

Watch for three concrete, monitorable items over the next 12 months: completion of the Hospices Civils de Lyon internal certification, any published or presented validation metrics tied to the cited cohorts (including the interim analysis of up to 832 patients), and details on broader commercial licensing or rollout plans. Each item will materially affect adoption momentum and commercial scale-up.

HENDERSON, Nev., Nov. 25, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the first sale of its Nu.Q® Cancer assays to one of Europe's leading cancer centers, the Hospices Civils de Lyon, in Lyon, France.

Professor Léa Payen, Professor in Toxicology and Biochemistry, Claude Bernard University of Lyon I and Hospices Civils de Lyon, France commented:
"We are delighted to place this first order of the Nu.Q® Cancer assays to complete the internal certification process ahead of introducing the test into routine clinical practice in our hospital network for cancer management.

"We have worked closely with the Volition team over several years to develop the strong scientific and clinical evidence to support the use of Nu.Q® in the management of cancer patients. Our results indicate that measuring methylated nucleosome biomarker levels at Non Small Cell Lung Cancer diagnosis can provide valuable information about survival, progression-free survival and, crucially, enhance the identification of patients who may benefit from curative care.^1-3"

Dr. Andrew Retter, Chief Medical Officer, Volition, added:
"Research conducted by the team at Lyon demonstrates that Nu.Q® Cancer technology empowers clinicians to make more informed treatment decisions and provides valuable new monitoring capabilities throughout the patient journey. By enriching clinical prognostication, Nu.Q® Cancer helps identify the most appropriate treatment pathway for an individual patient, supporting efforts to improve overall survival and deliver patient-centred care. 

"Nu.Q® Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring."

Mr. Gael Forterre, Chief Commercial Officer, Volition concluded:
"This is a major milestone for Volition in the commercialization and licensing of Nu.Q® in the human cancer field. We are now on the path to the first use of Nu.Q® in clinical practice, an exciting prospect which is core to Volition's mission, using our tests to help save lives. We look forward to providing more details soon."

^1. Grolleau E, et al. Circulating H3K27 Methylated Nucleosome Plasma Concentration: Synergistic Information with Circulating Tumor DNA Molecular Profiling. Biomolecules. 2023;13(8):1255. https://doi.org/10.3390/biom13081255
^2. Couraud S, et al  Baseline values of circulating nucleosomes in Lung Cancer: NUCLEO-LUNG study. ELCC 2024 Poster
^3. Marie Piecyk et al, "H3K27Me3-nucleosome is a strong prognostic biomarker in Non-Small Cell Lung Cancer: interim results from the analysis of up to 832 patients at baseline" Poster 395 ELCC 2025

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 detect and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early detection 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 an office in 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 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, Volition's expectations regarding future publications, Volition's success in securing licensing and/or distribution agreements with third parties for its products, and Volition's expectations regarding the terms of such agreements. 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 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™, Capture-Seq™ 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. Additionally, unless otherwise specified, all references to "$" refer to the legal currency of the United States of America.

 

 

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SOURCE VolitionRx Limited

FAQ

What did VolitionRx (VNRX) announce on November 25, 2025 about Nu.Q® Cancer?

VolitionRx announced its first sale of Nu.Q® Cancer assays to Hospices Civils de Lyon to complete clinical certification ahead of routine clinical use.

Which hospital bought the first Nu.Q® Cancer assays from VNRX and where is it located?

Hospices Civils de Lyon in Lyon, France purchased the first Nu.Q® Cancer assays.

Why is Hospices Civils de Lyon ordering Nu.Q® Cancer assays from VNRX?

The assays will be used to complete internal certification so the test can be introduced into routine clinical practice for cancer management.

What clinical benefit does VolitionRx claim for Nu.Q® Cancer in NSCLC?

The company cites evidence that methylated nucleosome levels at NSCLC diagnosis provide information on survival and progression‑free survival and can help identify patients who may benefit from curative care.

Does the November 25, 2025 announcement indicate Nu.Q® is in routine clinical use now?

No; the sale is described as completing certification ahead of introducing Nu.Q® into routine clinical practice, not as broad clinical deployment.

Where can clinicians find supporting studies referenced by VolitionRx for Nu.Q® Cancer?

The announcement references peer‑reviewed and conference sources including Biomolecules 2023 and ELCC posters from 2024 and 2025 cited in the announcement.