Volition Issues Business Review 2025

Rhea-AI Summary

Volition (NYSE AMERICAN: VNRX) issued its Business Review 2025 outlining commercial, clinical, and IP milestones as it commercializes the Nu.Q platform.

Key points: first clinical order for the Nu.Q Cancer assays for lung cancer, inclusion of the Nu.Q NETs assay in a government-backed ~$7.3 million French sepsis evaluation, first revenue from the CE‑Marked Nu.Q NETs automated assay, signed human‑licensing agreements with Werfen and Hologic, and a payable $5 million contractual milestone tied to feline lymphoma results.

Scientific advances highlighted include Capture-Seq™ with 180-fold (18,000%) ultrashort DNA enrichment and peer‑reviewed NETs data (1,713 patients) supporting clinical utility.

Positive

• First clinical order for Nu.Q Cancer assays for lung cancer
• Inclusion in a government-backed ~ $7.3 million French sepsis program
• First revenue from CE‑Marked Nu.Q NETs automated assay in Q1 2025
• Signed human-licensing agreements with Werfen and Hologic
• Capture-Seq™ achieved 180-fold (18,000%) ultrashort DNA enrichment

Negative

• None.

Key Figures

France sepsis program funding $7.3 million Government-backed early detection of sepsis program including Nu.Q® NETs assay

Hospitals evaluating Nu.Q NETs More than 20 hospitals Clinical evaluations across multiple NETs-related indications

Countries evaluating assay 10 countries Nu.Q® NETs evaluations across different healthcare systems

Clinical use cases 15 indications Nu.Q® NETs evaluations across 15 clinical use cases

NETs study size 1,713 patients Independent peer-reviewed Nu.Q® NETs study

Capture-Seq enrichment 180-fold (18,000%) Ultrashort DNA enrichment claimed as potential world-first breakthrough

Feline lymphoma milestone $5 million Contractual milestone expected upon publication of cat lymphoma study results

MCED / liquid biopsy TAM $23 billion Annualized total addressable market for multi-cancer early detection / liquid biopsy

Market Reality Check

$0.2674 Last Close

Volume Volume 1,066,213 is only 0.38x the 20-day average of 2,828,548, showing muted trading interest ahead of this update. low

Technical Shares at $0.2421 are well below the $0.55 200-day MA and 74.24% under the 52-week high, trading just 3.68% above the 52-week low.

Peers on Argus 1 Up

Sector peers show mixed moves, with several names down despite this upbeat business review. Momentum scanners flagged ICCM up 4.71%, while other close peers like Pulmonx, Apyx, and Cytosorbents show negative price changes, pointing to stock-specific rather than broad sector dynamics.

Common Catalyst ICCM’s peer news centers on FDA clearance and expected record North America sales, indicating company-specific clinical and commercial catalysts within the diagnostics/medical devices space.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 11	Liquid biopsy advance	Positive	+2.6%	Capture-Seq™ preprint with 180-fold cfDNA enrichment and large liquid biopsy TAM.
Dec 08	Clinical data lung	Positive	-0.7%	Nu.Q® Cancer lung abstracts showing prognostic value and first hospital order.
Dec 04	Sepsis program France	Positive	+9.5%	Nu.Q® NETs H3.1 chosen as sole biomarker in DETECSEPS sepsis initiative.
Nov 25	First cancer sale	Positive	-10.0%	First commercial sale of Nu.Q® Cancer assays for clinical certification in France.
Nov 13	Q3 2025 earnings	Negative	-4.4%	Q3 results with small revenue, continued losses, and cost controls highlighted.

Pattern Detected

Recent news often reads positively, but share reactions have been mixed, with several instances of sell-offs on favorable clinical or commercial milestones alongside aligned declines on weaker financial updates.

Recent Company History

Over the last six weeks, Volition reported multiple scientific and commercial milestones. A Dec 11 preprint detailed Capture-Seq™ with 180-fold cfDNA enrichment and a projected $23 billion TAM, following French DETECSEPS sepsis inclusion on Dec 4 and the first Nu.Q® Cancer clinical certification sale on Nov 25. Earlier, Q3 2025 results on Nov 13 highlighted small but growing revenue and ongoing losses. Today’s 2025 Business Review ties these strands together, emphasizing commercialization, licensing, and large TAMs.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-07-03

The company has an effective Form S-3 shelf registration filed on 2025-07-03, expiring on 2028-07-03. It has been used multiple times, as indicated by at least 4 associated prospectus supplements, suggesting ongoing access to registered capital-raising tools.

Market Pulse Summary

The stock surged +10.3% in the session following this news. A strong positive reaction aligns with the company’s emphasis on commercialization progress and large TAMs highlighted in this review. Recent history shows both aligned and divergent moves on good news, so sustained gains have not been guaranteed. Investors have also faced ongoing capital-raising, supported by an effective shelf filed on 2025-07-03. Monitoring future licensing deals, clinical deployments, and any new issuance against today’s $0.2421 baseline would remain important.

Key Terms

epigenetics medical

"a multi-national epigenetics company, issues a Business Review of 2025."

Epigenetics is the study of how environmental factors and experiences can influence how genes are turned on or off without changing the underlying genetic code. Think of it like a dimmer switch for a light, adjusting the brightness without altering the bulb itself. This process can affect health, behavior, and even how diseases develop, which is important for investors interested in long-term trends in medicine, wellness, and biotech industries.

antiphospholipid syndrome medical

"The first for Antiphospholipid Syndrome ("APS") with Werfen, and a Co-Marketing"

A disorder in which the immune system mistakenly targets certain blood-coating proteins, causing the blood to clot more easily and sometimes leading to strokes, deep vein clots, pregnancy loss, or other organ damage. Investors should care because the condition affects demand for diagnostics, therapies and monitoring, can influence clinical trial design and regulatory risk for related drugs, and may create liability or market opportunity similar to a new safety standard reshaping an industry.

netosis medical

"NETs, or more specifically NETosis, goes far beyond just sepsis, and is"

Netosis is a process where a type of white blood cell ejects a sticky web-like mesh to trap germs, sacrificing itself in the process. While intended as a protective response, these nets can also spark inflammation, blood clots or tissue damage, so they matter to investors because drugs that alter netosis can become new therapies or safety risks, affect clinical trial outcomes, and influence regulatory and market value for companies working on related diagnostics or treatments.

neutrophil extracellular traps medical

"High Throughput NETs method that measures Neutrophil Extracellular Traps ("NETs")"

Neutrophil extracellular traps (NETs) are web-like strands of DNA and proteins expelled by certain white blood cells to trap and neutralize invading germs, like a spider spinning a sticky web to catch insects. For investors, NETs matter because they are linked to inflammation, blood clots and chronic disease, making them potential targets for new diagnostics and therapies and a factor in safety and efficacy assessments for drug and device development.

phase 1/2b medical

"Nu.Q® Discover biomarkers in a longitudinal Phase 1/2b study, the first human"

Phase 1/2b is a combined early-stage clinical trial that first tests a drug or vaccine for safety and appropriate dosing in a small group, then expands to a larger group to look for initial signs that it works and to refine the best dose. For investors this matters because successful results reduce scientific and regulatory risk, create clear development milestones and can materially increase a company’s value much earlier than separate, slower trials—think of it as first testing a recipe with a few cooks, then inviting a bigger tasting to confirm it really works.

lateral flow test medical

"announced the groundbreaking Lateral Flow Test for Point-of-Care Quantification"

A lateral flow test is a quick, portable diagnostic strip that detects a specific substance from a small sample (like a nasal swab or saliva) and shows a visible line if the target is present—similar to how a home pregnancy test works. Investors care because these tests can generate rapid sales, face regulatory approvals, and depend on manufacturing and supply chains, so changes in demand, rules, or production affect company revenue and stock value.

nucleosomes medical

"Lateral Flow Test for Point-of-Care Quantification of Nucleosomes. This technological"

Nucleosomes are the basic units of DNA packaging in cells, where long strands of DNA are wrapped around small protein “spools” called histones, like thread wound on a bobbin. They matter to investors because how tightly DNA is wound affects which genes are turned on or off, making nucleosomes central to drug targets, diagnostics and epigenetic therapies that can alter gene activity and influence the value of biotech and pharma pipelines.

total addressable markets financial

"The Total Addressable Markets4 (TAMs) for our technologies, on an annualised"

An estimate of the total revenue opportunity available for a product or service if every potential customer in a defined market were to buy it, essentially the full size of the market 'pie.' Investors use it to judge how big a business could grow and to compare opportunities across companies; think of it as the pizza’s total size, not the slice a company is likely to actually capture.

AI-generated analysis. Not financial advice.

HENDERSON, Nev., Dec. 17, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, issues a Business Review of 2025.

Review of the Year by Cameron Reynolds, Group Chief Executive Officer

As 2025 draws to a close, I would like to take this opportunity to look back on the year's key milestones and look to the opportunities ahead.

Before diving into the detail, I would like to take a moment to reflect on our founding mission. We set out over fifteen years ago to help save lives and improve outcomes for millions of patients worldwide, and I could not be prouder of the progress we are making towards that goal.

In this fourth quarter we not only received our first order for the Nu.Q® Cancer assays for clinical certification ahead of routine clinical use in lung cancer, but we also announced the inclusion of our Nu.Q® NETs assay in a real-world interventional evaluation of early detection of sepsis, in a government-backed (~$7.3 million) program in France. Our tests are about to be used in both these devastating diseases to help save lives in real world hospital settings: an extremely proud moment for our entire team.

Cancer and sepsis are leading causes of death, accounting for approximately a third of deaths worldwide^1-3. With the first clinical use now imminent, we are about to be part of the solution, through simple, easy to use, low-cost tests.

I believe we will look back on 2025, and indeed in time, the next few quarters, as transformational for the company.

2025 efforts for Volition have focused on commercializing our groundbreaking Nu.Q® platform in the human diagnostics market. We were excited to start the implementation of our human licencing strategy; with the signing of not one, but two agreements. The first for Antiphospholipid Syndrome ("APS") with Werfen, and a Co-Marketing and Services Agreement with Hologic. Both are multi-billion-dollar companies, and worldwide leaders in their specialized fields, and we are delighted to report that both have very much hit the ground running.

We have further strengthened our Intellectual Property portfolio and are continuing our licensing discussions with around 10 of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of the negotiation process across all our different pillars, and we anticipate announcing additional agreements throughout 2026.

Our goal is to secure a wide range of licensing agreements in the human diagnostics space, mirroring our successful strategy in the veterinary market, and we anticipate diverse deal structures, with potential for up-front and milestone payments, and future recurring revenue. We have developed a truly remarkable, versatile platform and now we are working with governments and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide as quickly as possible.

Beyond licensing, we have achieved several significant commercial milestones:

• In the first quarter, we recorded our first revenue from sales of our CE-Marked Nu.Q® NETs automated assay, a regulated, clinically approved product.
  NETs, or more specifically NETosis, goes far beyond just sepsis, and is implicated in a very wide range of diseases.  Currently more than 20 hospitals in 10 countries are evaluating our Nu.Q® NETs assay across 15 different clinical use cases and indications. We believe NETs testing will become a key part of routine blood testing.
  
  
• In February, we announced our first commercial sale of Volition's proprietary High Throughput NETs method that measures Neutrophil Extracellular Traps ("NETs") activation and inhibition in whole blood in real time, helping companies develop new therapeutics to combat sepsis and other NETs-related disease.
  
  
• In March, we signed an agreement with a leading pharmaceutical company to utilize Volition's Nu.Q® Discover biomarkers in a longitudinal Phase 1/2b study, the first human clinical study with a pharmaceutical company sponsor that our test supports. Through our Nu.Q® Discover pillar we are now serving over 20 clients worldwide, including many top pharma and diagnostic companies, accelerating disease research and drug development across multiple therapeutic areas. 
  
  
• The Nu.Q® Vet Cancer Test is the number one canine cancer screening blood test in the world, available in over 20 countries.

We have also achieved significant scientific and clinical progress:

• Pre-print paper showcases both a new method, Capture-Seq™, and new biomarkers for the detection of cancer, with the potential for accurate, low-cost tests for a wide range of cancers. The 180-fold (18,000%) enrichment of ultrashort DNA, separating out the massive amounts of background DNA, is, we believe, a world-first breakthrough, and has generated significant interest from potential licensing partners. 
  
  
• Independent peer-reviewed and published study (1713 patients) clearly demonstrates that Nu.Q® NETs is a clinically meaningful, biologically specific marker of NETosis, with actionable potential in defined patient subgroups. This evidence positions the assay not as a traditional rule-in/rule-out diagnostic, but as a dynamic tool for prognostic enrichment, therapeutic targeting, and clinical monitoring.
  
  
• In July, Volition announced the groundbreaking Lateral Flow Test for Point-of-Care Quantification of Nucleosomes. This technological breakthrough is the first report of a bedside lateral flow test to quantify nucleosomes, a marker of NETosis. It is not simply a positive/ negative test but provides a quantitative readout to facilitate clinical decision-making.
  
  
• In January, we announced the results of a large-scale study which shows that  our Nu.Q®NETs H3.1 biomarker is an independent predictor of 28-day mortality and need for renal replacement therapy (RRT) in sepsis and septic shock patients.
  
  
• In May, we announced the successful detection of nucleosomes in cats and the publication of a peer-reviewed pre-analytics paper. We have subsequently completed our first clinical study to detect lymphoma in cats and look forward to publishing the results early in 2026, a development which will unlock a $5 million contractual milestone payment in due course.

Our Commercial Opportunities:

Our vision is for our tests to be used first by millions, then by tens, then hundreds of millions of people and animals a year, with our platform licensed to a range of large diagnostic and liquid biopsy companies (and governments) worldwide. Combining our groundbreaking technology with their installed base of laboratories, analyzer machines and sales forces around the world will achieve the optimal outcome for us – large companies have the resources to realise the opportunities better than Volition.

The Total Addressable Markets⁴ (TAMs) for our technologies, on an annualised basis, are considerable, multi-billion-dollar opportunities, not only for Volition, but for our licensing partners:

• $2.3 billion Lung Cancer Screening & Management
  
  
• $23 billion Multi-Cancer Early Detection / Liquid Biopsy
  
  
• $2.8 billion Sepsis Early Detection & Management
  
  
• $1 billion Broader NETosis (Trauma, Antiphospholipid Syndrome, Hidradenitis Suppurativa)
  
  
• $128 million Canine and Feline Cancer Screening
  
  
• $991 million Pharma Companion Diagnostic

We have dedicated the last fifteen years to revolutionizing the diagnosis and monitoring of life-altering diseases by advancing the science of epigenetics. When we started, we believed epigenetics would be an important part of oncology diagnostics in humans. Since then, our platform has shown an even broader utility by becoming the biggest selling test in canine cancer, and we are on the way to becoming a leader in NETs detection and monitoring.

While there is no doubt it has been a tough couple of years in the market, Volition has made strong progress, both clinically and commercially, and our technology is now poised to  be used very widely in a wide range of clinical utilities.

1.        UN, World Population Prospects (2024) (accessed on 15^th December 2025)

2.        Global Cancer Observatory 2022 (accessed on 15^th December 2025)

3.        Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. Rudd, Kristina E et al. The Lancet, 2020. https://doi.org/10.1016/S0140-6736(19)32989-7

4.        Data on File: Volition TAM

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

 

 

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SOURCE VolitionRx Limited

FAQ

What did Volition announce about Nu.Q Cancer assays on December 17, 2025 (VNRX)?

Volition reported its first clinical order for Nu.Q Cancer assays for clinical certification ahead of routine lung cancer use.

How is Volition involved in sepsis testing under the December 2025 business review (VNRX)?

Volition announced Nu.Q NETs inclusion in a government-backed ~ $7.3 million real-world interventional evaluation of early sepsis detection in France.

What commercial milestones did Volition report for 2025 (VNRX)?

Volition recorded first revenue from the CE‑Marked Nu.Q NETs automated assay and announced agreements with Werfen and Hologic.

What scientific breakthrough did Volition disclose in the 2025 review (VNRX)?

Volition disclosed Capture-Seq™ with a reported 180-fold (18,000%) enrichment of ultrashort DNA for cancer detection.

Is there any near-term contractual revenue noted in Volition's 2025 review (VNRX)?

Yes; Volition expects a $5 million contractual milestone payment tied to feline lymphoma study results to be unlocked after publication.

What clinical evidence supports Volition's Nu.Q NETs assays according to the 2025 review (VNRX)?

An independent peer‑reviewed study of 1,713 patients demonstrated Nu.Q NETs as a biologically specific marker with actionable clinical potential.