Volition Solves Liquid Biopsy's "Needle in a Haystack" Problem; Achieves 180-fold (18,000%) Enrichment

Rhea-AI Summary

Volition (NYSE: VNRX) announced a preprint describing Capture-Seq™, a method that physically enriches ultrashort transcription factor–bound cfDNA for liquid biopsy. The company reports a 180-fold (18,000%) enrichment, removal of ~99% background DNA, and two patent-pending separation technologies. In a small training cohort of 70 subjects (49 cancer patients), analysis reportedly achieved 100% sensitivity and 100% specificity. Volition projects a $23 billion annual TAM and is seeking commercial partners; results require independent validation in larger studies.

Positive

• Physical enrichment achieved: 180-fold
• Background DNA reduced by ~99%
• 100% sensitivity in 70-person training cohort
• 100% specificity in 70-person training cohort
• Two patent-pending separation technologies
• Company cites $23B annual total addressable market

Negative

• Training cohort size limited to 70 subjects
• Reported results are preprint and need validation
• No independent or large-scale validation reported
• Patent status is pending, not granted

Key Figures

Enrichment achieved 180-fold (18,000%) Capture-Seq™ enrichment of transcription factor-bound cfDNA fragments

Background DNA removed 99% Background DNA eliminated before extraction in liquid biopsy workflow

Training cohort size 70 people Initial training cohort for Capture-Seq™ cancer detection study

Cancer patients 49 patients Breast, prostate, lung or colorectal cancer cases in training cohort

Sensitivity 100% Detection of cancer patients in the initial Capture-Seq™ cohort

Specificity 100% No false positives in the initial Capture-Seq™ training cohort

DNA reduction 99% Reduction in DNA volume required to be sequenced per test

Total Addressable Market $23 billion Annualized TAM estimate for the new technology

Market Reality Check

$0.2800 Last Close

Volume Volume 1,639,024 is below the 20-day average of 2,703,608, suggesting limited pre‑news positioning. low

Technical Shares at $0.28 were trading below the 200-day MA of $0.56 and about 70% under the 52-week high, near the 52-week low of $0.2719 before this announcement.

Peers on Argus 1 Up

Peers in medical devices showed mixed moves, with names like LUNG up 6.96% and CTSO down 6.2%, indicating today’s setup around VNRX looked more stock‑specific than a clear sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 08	Clinical data update	Positive	-0.7%	New Nu.Q® Cancer data and initial hospital order for clinical deployment.
Dec 04	Biomarker program news	Positive	+9.5%	Nu.Q® NETs H3.1 named sole biomarker in France’s DETECSEPS sepsis program.
Nov 25	Commercialization milestone	Positive	-10.0%	First Nu.Q® Cancer assay sale for clinical certification in France.
Nov 13	Q3 2025 earnings	Negative	-4.4%	Low revenue, ongoing losses, but lower cash burn and recent capital raise.
Nov 10	Earnings call notice	Neutral	+0.6%	Scheduling details for Q3 2025 earnings and business update conference call.

Pattern Detected

Recent history shows a mixed pattern: some positive clinical and commercialization updates saw negative price reactions, while macro or funding-related news (earnings, large programs) tended to align more closely with the subsequent price move.

Recent Company History

Over the last month, Volition reported several milestones. On Nov 25, it announced the first commercial sale of its Nu.Q® Cancer assays in France, framed as a commercialization milestone, yet the stock fell 9.97%. Earlier, Q3 2025 results on Nov 13 showed modest revenue of $0.6 million and reduced losses, but also ongoing challenges, with shares down 4.37%. More recently, inclusion of the Nu.Q® NETs assay in France’s DETECSEPS program on Dec 4 coincided with a 9.49% gain. The current Capture‑Seq™ breakthrough fits into this arc of recurring technical advances.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-07-03

The company has an effective S-3 shelf registration dated 2025-07-03, expiring on 2028-07-03, which has been used multiple times (at least 4 prospectus supplements, including 424B5 filings in August and October 2025). This structure provides flexibility to raise additional capital, which can support operations but may also introduce future equity issuance risk.

Market Pulse Summary

This announcement details a Capture‑Seq™ liquid biopsy method achieving 180-fold enrichment and removal of about 99% of background DNA, with an initial 70-person cohort showing 100% sensitivity and specificity. It follows recent Nu.Q® assay milestones and comes against a backdrop of ongoing losses and active capital-raising capacity via an S-3 shelf. Key factors to watch include larger independent validation studies, progress toward commercial partnerships, and how this technology integrates with the existing Nu.Q® portfolio.

Key Terms

liquid biopsy medical

"a novel biomarker for liquid biopsy". This paper showcases both a new method"

A liquid biopsy is a laboratory test that looks for tiny pieces of tumor or disease-related material — such as DNA, proteins, or cells — circulating in blood or other body fluids, allowing detection and monitoring without a surgical tissue sample. For investors, it matters because these tests can speed diagnosis, guide treatment choices, enable easier repeat testing, and create recurring revenue streams if adopted widely, affecting a medical company's growth and regulatory risk profile.

cfDNA medical

"factor protected cfDNA in plasma by ChIP-seq: Measurement of altered"

Cell-free DNA (cfDNA) is short fragments of genetic material that float freely in the bloodstream after cells die and release their contents. Investors care because cfDNA can be sampled with a simple blood draw to reveal signs of pregnancy complications, organ damage, or cancer without invasive procedures, making it the basis for high-growth diagnostic tests, monitoring tools and companion products that can change how diseases are detected and treated.

ChIP-seq medical

"cfDNA in plasma by ChIP-seq: Measurement of altered CTCF binding"

ChIP‑seq is a laboratory method that maps where specific proteins bind to DNA across the genome by isolating those DNA fragments and reading their sequences. For investors, it matters because the results reveal regulatory “on/off” sites that guide gene activity, helping drug developers identify targets, validate mechanisms, or create diagnostic markers—like a city map showing where key workers operate during rush hour.

transcription factor medical

"DNA fragments bound to a transcription factor is a key breakthrough"

A transcription factor is a protein that binds to specific spots on DNA to turn genes on or off, acting like a light switch or conductor that controls which cellular instructions are followed. For investors, transcription factors matter because they are common drug targets and biomarkers: understanding or altering their activity can create new therapies, influence clinical trial prospects, and affect the value of biotech and pharmaceutical companies.

biomarker medical

"binding in cancer is a novel biomarker for liquid biopsy". This paper"

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

AI-generated analysis. Not financial advice.

HENDERSON, Nev., Dec. 11, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, announces preprint availability of a new manuscript entitled "Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: Measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy". This paper showcases both a new method, Capture-Seq™, and new biomarkers for the detection of cancer, holding the promise of accurate, low-cost tests for a wide range of cancers.

Physical enrichment of ultrashort DNA fragments bound to a transcription factor is a key breakthrough allowing for the quantification in blood of combinations of potentially hundreds of binding sites associated with cancer that represent a new class of ultrashort DNA biomarkers not available to previous DNA analysis methods^{1, 2}. Volition has achieved 180-fold enrichment (18,000%) through our unique focus on chromosome fragments – the form in which DNA actually exists in the blood. In contrast, current methods focus on the DNA itself after it has been chemically extracted from the blood, when its context within a chromosome has been lost. 

Dr Jake Micallef, Chief Scientific Officer, Volition commented:

"This is, I believe, a world-first breakthrough – it is the first time that transcription factor-bound DNA has been physically separated from the massive amounts of background DNA in the blood, and could, in my opinion, represent the biggest scientific breakthrough in cancer testing in recent years.

"There is excitement in the world of liquid biopsy cancer DNA testing around the recent discoveries of ultrashort DNA fragments in the blood (including transcription factor-bound DNA), which hold great promise not only for accurate low-cost early cancer detection and cancer management, but also potentially for identifying the type of cancer present ³.

"Previous DNA liquid biopsy tests involve extraction of all DNA in the blood. A challenge faced by current technologies is that the overwhelming majority of DNA extracted from the blood is not cancer related but in fact "background" DNA. This background DNA interferes in DNA based liquid biopsy tests, especially tests for early-stage cancer. However, by isolating ultrashort DNA fragments bound to transcription factors using an antibody, Volition's technology removes 99% of background DNA before DNA extraction. Only ultrashort transcription factor-bound DNA is extracted and sequenced and the background DNA is washed away, solving the classic needle in a haystack problem. Moreover, this ultrashort transcription factor-bound DNA holds a great deal of additional information not available in the remaining 99% of DNA ⁴.

"In this paper we report that we have successfully separated out ultrashort transcription factor-bound DNA from blood and removed the background DNA, allowing accurate analysis, by sequencing, of those genes which are epigenetically altered in cancer – and hence to identify patients with cancer - with a relatively simple low-cost blood test. Reducing the amount of DNA to be sequenced by ~99% is also likely to make testing significantly less costly.

"Volition has now developed not one, but two, different patent-pending technologies that can separate ultrashort DNA from background blood DNA. The first of these and its potential use for accurate detection of cancer is described in the paper.

"In a first small training cohort of 70 people, including 49 patients with breast, prostate lung or colorectal cancer, analysis of ultrashort transcription factor-bound DNA was able to detect all the patients with cancer (100% sensitivity), including those with early stage I or stage II disease, with no false positives (100% specificity). This initial result needs to be confirmed in larger independent validation studies but holds great promise for the technology."

Mr Gael Forterre, Chief Commercial Officer, Volition added:

"This scientific breakthrough has not only generated a lot of interest within Volition but also with potential licensing partners. This new technology expands our existing Nu.Q® portfolio of tests in canine cancer screening and human lung cancer management which we are currently commercializing.

"We feel that this technology could, with further development, become very widely used and are actively seeking large commercial partner/s to work with us to accelerate the integration and launch of this technology as soon as possible.

"We believe this represents a significant commercial opportunity with a Total Addressable Market on an annualised basis of approximately $23 billion⁵."

1. Snyder et al, Cell 2016 Jan 14;164(1-2):57-68. https://doi.org/10.1016/j.cell.2015.11.050  
2. Hudecova et al, Genome Res. 2022 Feb;32(2):215-227. doi: 10.1101/gr.275691.121.
3. Fang et al, Genome Biol 21, 247 (2020). https://doi.org/10.1186/s13059-020-02152-7
4. Mundade et al, Cell Cycle. 2014;13(18):2847-52. https://doi.org/10.4161/15384101.2014.949201
5. Data on File : Volition TAM Model

About Volition

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 or associated video or link 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 or associated video or link are the property of their respective owners. Additionally, unless otherwise specified, all references to "$" refer to the legal currency of the United

Video - https://www.youtube.com/watch?v=WaKr17hKKBU

View original content to download multimedia:https://www.prnewswire.com/news-releases/volition-solves-liquid-biopsys-needle-in-a-haystack-problem-achieves-180-fold-18-000-enrichment-302639218.html

SOURCE VolitionRx Limited

FAQ

What did Volition (VNRX) announce on December 11, 2025 about Capture-Seq™?

Volition announced a preprint describing Capture-Seq™, reporting 180-fold enrichment of transcription factor–bound cfDNA and ~99% background removal.

How accurate was Volition's test in the December 2025 training cohort for VNRX?

In a small 70-person training cohort (49 cancer patients), the company reports 100% sensitivity and 100% specificity.

Does Volition (VNRX) have regulatory approval for Capture-Seq™ as of December 11, 2025?

No regulatory approval is reported; the results are from a preprint and require further validation.

What commercial opportunity did Volition (VNRX) cite for the new technology?

Volition cited an annualized $23 billion total addressable market and is seeking large commercial partners.

What are the main limitations of Volition's December 2025 announcement (VNRX)?

Key limitations are the small cohort (70), preprint status, and absence of independent large-scale validation.