Volition Introduces Nu.Q® Cancer Blood Test in New Industry Primer for Lung Cancer

Rhea-AI Summary

VolitionRx (NYSE AMERICAN: VNRX) has released a new lung cancer primer titled 'Lung Cancer: Hope of a Brighter Tomorrow,' showcasing their Nu.Q® Cancer blood test technology. The report highlights the potential of Nu.Q® Cancer assays in revolutionizing lung cancer diagnosis, treatment, and monitoring in the $4 billion lung cancer market.

The technology offers easy-to-administer, low-cost blood tests that can be integrated with existing methods like Low Dose Computed Tomography and Next Generation Sequencing (NGS). A notable 1050-patient retrospective study on Non-Small Cell Lung Cancer associated with NGS will be presented at the upcoming European Lung Cancer Congress in Paris.

The company is currently in discussions with major diagnostics and liquid biopsy companies, aiming to secure multiple licensing agreements this year. Nu.Q® Cancer tests can be run on existing automated chemiluminescence platforms worldwide, making them potentially widely accessible through licensing and partnership arrangements.

Positive

• Large market opportunity with $4 billion Total Annual Accessible Market for lung cancer applications
• Advanced commercialization discussions with major diagnostics companies for potential licensing agreements
• Technology compatible with existing worldwide platforms, requiring no new hardware investment
• Substantial clinical validation with 1050-patient retrospective study

Negative

• No current revenue or commercial agreements announced yet
• Product still in development phase without regulatory approvals mentioned

Insights

Medical Diagnostics Expert

Volition's announcement introduces their Nu.Q® Cancer blood test as a potential advancement in lung cancer detection and monitoring. This technology targets multiple intervention points in the patient journey - from initial screening to treatment selection and post-treatment monitoring.

The company's approach leverages nucleosome-based biomarkers (specifically H3.1 and H3K27Me3) which can be detected through blood samples. The key technical advantage is compatibility with existing automated chemiluminescence platforms, eliminating the need for specialized equipment and potentially accelerating clinical adoption.

The referenced 1050-patient retrospective study of treatment-naïve Non-Small Cell Lung Cancer in conjunction with Next Generation Sequencing represents a meaningful data set, though specific performance metrics (sensitivity, specificity) aren't disclosed in this release. Publication at the European Lung Cancer Congress will likely provide these critical details.

The diagnostic strategy of combining Nu.Q® Cancer with established methods like Low Dose Computed Tomography and NGS follows a sensible complementary approach rather than attempting to replace existing standards of care. This integration strategy typically faces fewer clinical adoption barriers when supported by robust data.

While promising, Volition must demonstrate how their technology meaningfully improves existing diagnostic paradigms through enhanced accuracy, earlier detection capability, or cost advantages to capture market share in the competitive liquid biopsy space.

Biotech Investment Analyst

Volition's strategic positioning in the $4 billion lung cancer diagnostics market merits attention as the company advances its Nu.Q® technology platform. Rather than pursuing direct commercialization, management has adopted a licensing-focused approach to maximize market penetration through existing diagnostic infrastructure.

The company reports active discussions with several large diagnostics and liquid biopsy companies with the explicit goal of signing multiple licensing agreements this year. This strategy leverages Volition's intellectual property while minimizing the capital requirements of building a commercial organization.

From a commercial perspective, the compatibility with existing automated platforms represents a significant advantage. This approach eliminates the adoption barrier of capital equipment purchases while enabling Volition to potentially generate royalty streams across multiple partner platforms.

The addressable market segmentation across screening, prognostication, and minimal residual disease monitoring creates multiple revenue opportunities. However, each segment has distinct reimbursement pathways and adoption challenges that will require targeted evidence development.

For investors, the key metrics to monitor will be: 1) The number and quality of licensing partnerships secured, 2) The performance metrics from the forthcoming clinical publication, and 3) Progress toward regulatory approvals. While the market opportunity is substantial, commercial execution through effective partnerships will determine whether Volition can capture meaningful market share in this competitive diagnostic space.

 "Lung Cancer: Hope of a Brighter Tomorrow" illustrates how Nu.Q® Cancer Test aims to transform the diagnosis, treatment and monitoring in the $4 billion lung cancer market¹

HENDERSON, Nev., March 20, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the release of Volition's new lung cancer primer, "Lung Cancer: Hope of a Brighter Tomorrow." The report introduces Volition's Nu.Q® Cancer assays² in development to revolutionize the early detection and monitoring of lung cancer via easy to administer and low-cost assays which will utilize only a small amount of blood.

Dr Andrew Retter, Chief Medical Officer, Volition noted:
"We are delighted to publish this report ahead of the European Lung Cancer Congress due to be held in Paris 26^th to 29^th March and would like to thank our collaborators for their contributions.

"The data included in this report demonstrates a compelling case for the use of Nu.Q® Cancer at multiple points in the patient journey.  From screening and aiding treatment selection, to monitoring patients during and after treatment, using Nu.Q® Cancer alongside existing methods such as Low Dose Computed Tomography and/or Next Generation Sequencing (NGS) could significantly improve survival from this deadly disease.

 "We are excited that evidence from a 1050-patient retrospective study of treatment naïve Non-Small Cell Lung Cancer associated with NGS will be published by the Hospices Civils de Lyon team at the Congress."

Gael Forterre, Chief Commercial Officer at Volition commented:
"We are in active discussions regarding our cancer portfolio with several large diagnostics and liquid biopsy companies, with the goal of signing multiple licensing agreements this year. The Total Annual Accessible Market for lung cancer (screening, prognostication and identification of minimal residual disease) is estimated to be approximately $4 billion, representing a significant revenue opportunity for Volition¹.

"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. This report provides invaluable insight and evidence in support of Nu.Q® Cancer throughout a lung cancer patient's journey."

Download Volition's full report titled: "Lung Cancer: Hope of a Brighter Tomorrow".

Footnotes

1. Data on file Volition TAM model (Countries limited to U.S., Japan, France, Germany, UK)
2. Nu.Q® Lung Cancer assays: Nu.Q® H3.1 and Nu.Q® H3K27Me3

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 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

FAQ

What is the market size for Volition's Nu.Q® Cancer test in lung cancer?

The Total Annual Accessible Market for lung cancer applications is approximately $4 billion, covering screening, prognostication, and minimal residual disease identification.

How does VNRX plan to commercialize the Nu.Q® Cancer test?

Volition aims to secure multiple licensing agreements with major diagnostics companies and utilize existing automated chemiluminescence platforms through partnerships.

What is the scope of the lung cancer study being presented for VNRX's Nu.Q® test?

A 1050-patient retrospective study of treatment naïve Non-Small Cell Lung Cancer associated with NGS will be presented by Hospices Civils de Lyon at the European Lung Cancer Congress.

What are the key applications of VNRX's Nu.Q® Cancer test in lung cancer?

The test can be used for screening, aiding treatment selection, and monitoring patients during and after treatment, complementing existing diagnostic methods.