VolitionRx Limited (NYSE: VNRX) published the first peer-reviewed paper describing its Capture-Seq™ liquid biopsy technology on Aug. 5, 2026. The publication in Clinical Epigenetics validates a method that isolates >99% pure circulating tumor-derived DNA (ctDNA) from plasma. This development positions the company to target a $36 billion total addressable market (TAM) by combining applications in Multi-Cancer Early Detection (MCED) and Minimal Residual Disease (MRD). Volition is currently in active discussions with global diagnostic leaders to accelerate commercialization through licensing agreements.

The study, titled "Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq," details a two-step process involving physical enrichment followed by bioinformatic removal of non-tumor cell-free DNA sequences. Dr. Jake Micallef, Chief Scientific Officer at Volition, stated that the technology reveals almost no CTCF-bound DNA in healthy plasma, whereas nearly all such DNA in cancer patients is tumor-derived. This approach allows for the creation of virtually pure cancer DNA datasets from blood samples.

Clinical Validation Results

Early blinded validation results reported in the paper demonstrate high sensitivity across independent cohorts. In the first cohort, the technology detected 49/49 cancers, including 23 early-stage (Stage I/II) cases, with no false positives among 21 controls. A second blinded cohort validated these findings, detecting 13/14 later-stage cancers with zero false positives among 10 additional controls. Subsequent data from a separate blinded validation cohort of 81 subjects showed a 95% detection rate for Stage I and II cancers.

Market Opportunity and Commercialization

Gael Forterre, Chief Licensing Officer at Volition, highlighted the commercial potential of the technology, noting active technical evaluations with potential licensors. The company estimates an annualized TAM of approximately $23 billion for human MCED use and over $13 billion for MRD applications. Volition has filed multiple new patents to protect this technology, focusing on circulating cell-free nucleoproteins. Dr. Andrew Retter, Medical Consultant at Volition, emphasized that if validated in larger cohorts, CTCF Capture-Seq™ could fulfill a significant unmet clinical need in early detection and treatment monitoring.

What the Numbers Show

The divergence between traditional liquid biopsy limitations and Volition’s reported purity levels represents a structural shift in diagnostic capability. By achieving >99% purity of ctDNA, the technology mitigates the signal-to-noise ratio issues that typically require expensive deep sequencing to overcome. The 100% detection rate in the initial cohort of 49 patients suggests that the physical enrichment step effectively concentrates low-abundance tumor signals. However, the transition to larger validation sets shows a slight decrease in early-stage detection sensitivity (from 100% to 95%), indicating that performance metrics may stabilize as sample complexity increases.

VolitionRx Limited (NYSE: VNRX) advanced its Nu.Q® NETs platform toward commercialization on July 30, 2026, citing consistent international clinical data that positions the technology as a potential game changer in sepsis management. The multi-national epigenetics company identified a Total Addressable Market (TAM) of approximately $3.8 billion on an annualized basis, driven by the need for accurate differentiation between sepsis and non-infectious systemic inflammation. This development signals a shift from research to potential revenue generation as Volition engages with major diagnostic partners to scale its nucleosome quantification technology.

The company released a comprehensive update detailing the scientific evidence amassed for Nu.Q® NETs, alongside a video featuring Critical Care Lead Dr Andrew Retter. The findings indicate that Nu.Q® H3.1 accurately distinguishes sepsis from other inflammatory conditions and correlates highly with disease severity. Professor Djillali Annane of IHU SEPSIS noted that the consistency of data across different countries and sepsis types provides significant prognostic utility for outcomes such as organ failure and mortality.

Commercial Strategy and Market Opportunity

Gael Forterre, Chief Commercial Officer at Volition, confirmed that the company is in active discussions with several large diagnostic companies to accelerate the development of Nu.Q® NETs. These partnerships aim to leverage the test’s potential use cases within a $3.8 billion annualized market. The strategy focuses on integrating Nu.Q® NETs into hospital settings to modify patient trajectories through early detection of elevated H3.1 nucleosome levels.

Clinical Validation and Scientific Evidence

Dr Andrew Retter emphasized that a significant body of scientific and clinical evidence now supports the use of Volition’s Nu.Q® NETs assay in diseases associated with NETosis. Most of these papers have been peer-reviewed and published. The technology offers a simple, low-cost, and accessible test to detect diseases linked to elevated NETs, which can lead to tissue damage, organ failure, and death if left untreated.

Professor Annane highlighted that Nu.Q® H3.1 provides new information above standard organ failure scores such as APACHE II and SOFA scores. This additional layer of data allows for more precise treatment strategies, potentially improving patient survival rates and the quality of life for survivors. The company’s research centers in Belgium, the U.S., and London continue to drive these advancements.

What the Numbers Show

The valuation of the sepsis biomarker market at $3.8 billion underscores the high stakes for Volition’s commercialization efforts. Unlike general inflammatory markers, Nu.Q® H3.1’s ability to distinguish infectious from non-infectious causes addresses a critical gap in critical care diagnostics. The consistency of data across multiple international studies reduces the risk of false positives, a key barrier to adoption in hospital settings. Success in securing licensing agreements will depend on demonstrating cost-effectiveness and improved patient outcomes compared to existing standards.