Volition Announces Groundbreaking Lateral Flow Test for Point-of-Care Quantification of Nucleosomes

Rhea-AI Summary

VolitionRx (NYSE AMERICAN: VNRX) has achieved a significant breakthrough in medical diagnostics by developing a lateral flow test that can quantify nucleosomes in whole venous blood within minutes. The company conducted a blinded study under the SUMMIT program, testing blood samples from 25 hospital patients in Intensive Care and Emergency Departments.

The new test shows strong correlation with Volition's established Nu.Q® nucleosome assay, enabling rapid detection of immune disruptions associated with conditions like sepsis. Unlike traditional positive/negative tests, this innovation provides quantitative results at the point-of-care, eliminating the need for laboratory processing.

The company plans to advance the SUMMIT program by developing a finger-prick version using capillary blood for broader applications.

Positive

• None.

Negative

• Technology still requires validation with capillary blood samples
• Currently limited to venous blood samples only
• Study sample size relatively small at 25 patients

Insights

Medical Diagnostics Specialist

Volition's new lateral flow test for quantifying nucleosomes represents significant diagnostic advancement with potential to revolutionize point-of-care sepsis detection.

This technological breakthrough marks a significant advancement in point-of-care diagnostics by enabling quantitative measurement of nucleosomes in whole blood within minutes. Traditional lateral flow tests typically provide only qualitative (positive/negative) results, but Volition's device delivers precise quantification comparable to their laboratory-based Nu.Q® platform.

Nucleosomes are DNA-protein complexes released during cell death and NETosis (Neutrophil Extracellular Trap formation), a process strongly implicated in sepsis pathophysiology. Elevated nucleosome levels serve as early biomarkers for immune dysregulation and potential septic shock, where time-to-treatment is critically linked to survival rates.

The clinical implications are substantial. Sepsis requires urgent intervention, with mortality increasing approximately 8% for each hour treatment is delayed. Current diagnosis relies on laboratory tests that can take hours. This device could dramatically compress the diagnostic timeline, enabling rapid triage and treatment initiation in emergency settings.

The technology's versatility extends beyond sepsis to potentially monitor other conditions characterized by excessive cell death or NETosis, including severe trauma, COVID-19 complications, and autoimmune flares. The planned progression to capillary blood testing would further enhance accessibility, particularly in resource-limited settings where laboratory infrastructure is minimal.

While promising, validation in larger cohorts across diverse clinical settings will be essential to establish definitive sensitivity and specificity parameters before widespread clinical adoption.

Biotech Investment Analyst

Volition's announcement represents a potential inflection point for the company's commercial trajectory. This lateral flow technology significantly expands their addressable market by bridging the gap between central laboratory testing and point-of-care diagnostics—a segment projected to reach $50.6 billion globally by 2025.

The technology offers three distinct competitive advantages: (1) quantitative results rather than binary outcomes, (2) rapid turnaround without specialized equipment, and (3) versatility across multiple high-need indications. The sepsis diagnostic market alone is estimated at $700 million annually and growing at 8-10% CAGR.

This development potentially accelerates Volition's path to broader commercialization. Their Nu.Q® platform has shown promise but faced adoption barriers due to laboratory infrastructure requirements. This point-of-care solution could drive faster market penetration, particularly in emergency departments where immediate results significantly impact clinical decision-making.

The technology also creates substantial opportunities in resource-limited settings and developing markets where laboratory capacity constraints have limited diagnostic testing. With plans to advance to capillary blood testing, Volition could further reduce implementation barriers.

While encouraging, investors should note several hurdles remain: regulatory approval timelines, manufacturing scale-up challenges, and market education requirements. The announcement doesn't specify timeline to commercial availability or projected costs, key factors that will determine ultimate market penetration and revenue potential.

HENDERSON, Nev., July 8, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces it has demonstrated quantification of nucleosomes in whole venous blood in minutes utilizing a simple lateral flow device. The blinded study, part of the SUMMIT program,  tested blood samples from 25 hospital patients in Intensive Care or at the Emergency Department. The results correlated strongly with those of Volition's established automated central laboratory Nu.Q® nucleosome assay, demonstrating the feasibility of early detection of immune disruptions that can occur in a range of conditions including sepsis, simply and rapidly in a doctor's office, Emergency Department or Intensive Care setting without the need to send a blood sample to a hospital laboratory for testing.

Mr. Gael Forterre, Chief Commercial Officer, Volition said:

"The ability to rapidly identify high-risk patients at the Point-of-Care by quantifying their nucleosome levels using a simple lateral flow device could enable quicker clinical decision making and consequently better patient outcomes.

"This is a potential gamechanger, not only in diseases where time is critical such as sepsis, but also in providing our tests to lower-income countries where laboratory infrastructure may be weak or non-existent.

"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.

"The next phase of the SUMMIT program is to demonstrate use with capillary blood, with the ultimate goal of providing a finger-prick test for additional use cases."

About SUMMIT (Sepsis: addressing unmet needs for disease monitoring with a rapid test)

This innovative project, aimed at developing a capillary blood-based Lateral Flow test for the early diagnosis of sepsis, is carried out with the financial support of the Walloon Region.

About Lateral Flow Tests

The first commercial Lateral Flow Test (LFT), the Clearblue pregnancy test, was launched in the late 1980s. More recently, LFTs for COVID-19 virus were widely used during the COVID-19 pandemic. LFTs are designed to rapidly detect a molecule of interest in a simple test that can be conducted immediately on a patient's blood, urine or saliva sample in a doctor's office or even a home setting by a person with no scientific training and using no specialized equipment.

About Volition's Nu.Q® Nucleosome Assay

The Volition Nu.Q® nucleosome assay is a chemiluminescent immunoassay (ChLIA) that runs on the  Immunodiagnostic Systems (IDS) i10® automated analyzer platform. It holds a CE Mark to aid in the detection and evaluation of diseases associated with NETosis and is available in 27 European Countries.

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, the exercise of the milestone-linked warrants upon the achievement of such milestone events or otherwise prior to their expiration, 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 of Volition's cost reduction measures, 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 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 breakthrough did VolitionRx (VNRX) announce in their lateral flow test development?

VolitionRx announced the development of the first-ever lateral flow test that can quantify nucleosomes in whole venous blood within minutes, correlating strongly with their established laboratory Nu.Q® assay.

How many patients were included in VolitionRx's SUMMIT program study?

The blinded study included 25 hospital patients from Intensive Care and Emergency Departments.

What are the potential applications of VolitionRx's new lateral flow test?

The test can be used for early detection of immune disruptions in conditions like sepsis, and has potential applications in doctor's offices, Emergency Departments, and Intensive Care settings, particularly in regions with limited laboratory infrastructure.

What is the next phase of VolitionRx's SUMMIT program?

The next phase aims to demonstrate the test's effectiveness with capillary blood, working toward developing a finger-prick test for additional use cases.

How does VolitionRx's new lateral flow test differ from traditional tests?

Unlike traditional positive/negative tests, this innovation provides a quantitative readout to facilitate clinical decision-making, marking the first bedside lateral flow test to quantify nucleosomes.