Targets $36 Billion TAM in Early Cancer Detection and MRD.
Company in active discussions with global diagnostic leaders to accelerate commercialization.
Henderson, Nevada, August 5, 2026 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-national epigenetics company, was the first to demonstrate the isolation and analysis of >99% pure circulating tumor-derived DNA (ctDNA). Volition today announces the publication of the first peer-reviewed paper describing the technology in detail – 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 biopsy1”.
Most current liquid biopsy methods involve deep sequencing of plasma DNA and bioinformatic analysis of the data produced to identify the presence of cancer in a patient. The biggest problem facing all liquid biopsy methods worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not cancer cells. Volition’s new technology employs an entirely novel approach to liquid biopsy that has overcome this hurdle and produced >99% pure cancer associated plasma DNA sequence sets for liquid biopsy.
Mr. Gael Forterre, Chief Licensing Officer, Volition added:
“We are delighted that the paper detailing this breakthrough technology has been peer reviewed and published.
“We are in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development of this technology, “Capture-Seq™”, and indeed are in the process of undertaking technical evaluations with potential licensors.
“We believe the potential use cases for Capture-Seq™ represent a significant commercial opportunity with a Total Addressable Market on an annualized basis of approximately $23 billion2 for the human Multi-Cancer Early Detection (MCED) use, and over $13 Billion2 for Minimum Residual Disease (MRD).”
Dr Jake Micallef, Chief Scientific Officer, Volition commented:
“Distinguishing cancer derived plasma DNA from healthy DNA when the two are mixed is problematic as they are chemically similar. As the cancer DNA may make up 1% or less of the total DNA, it is extremely problematic.
“Our manuscript describes a new liquid biopsy chemistry for isolating CTCF-DNA from plasma. Our work on CTCF-bound DNA has revealed what we believe to be an unprecedented new discovery; that there is almost no CTCF-bound DNA in healthy plasma and almost all CTCF-bound DNA in the blood of a cancer patient is derived from cancer cells – i.e. it is virtually pure circulating tumor-derived DNA.
“Removal of background normal cell free DNA from the blood to reveal this level of tumor derived DNA has been a long term goal of liquid biopsy. I believe this is a world-first and could, in my opinion, represent the biggest scientific breakthrough in cancer testing and monitoring in recent years.
“In this published paper we report a new, two-step method for preparing pure circulating tumor DNA data sets for cancer patients:
- physical enrichment of the sample; and
- bioinformatic removal of virtually all remaining non-tumor cfDNA sequences from the DNA sequence data set.
“This new method produced >99% pure ctDNA sequencing data sets for blood samples from cancer patients and, whilst we capture a subset of the ctDNA (i.e. not all the ctDNA in a sample), it is virtually pure cancer DNA.
“These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers. Capture-Seq™ shows potential for both a multi-cancer early detection (MCED) approach, either alone or in combination with other tests, and the detection of Minimal Residual Disease (MRD).
“We are fast-tracking the development of Capture-Seq™ conducting further studies, including competing conditions and larger sample sets and working with oncology Key Opinion Leaders.
“Volition is, I believe, the first liquid biopsy company to focus on circulating cell free nucleoproteins and we have filed a number of new patents to protect this technology.”
Dr Andrew Retter, Medical Consultant, Volition commented:
“From a clinical perspective, the proof of concept and early blinded validation results reported in this paper are extremely encouraging. In two independent cohorts we reported no false positives and detected 49/49 cancers in the first cohort (including 23 early stage I/II and 21 controls) and validated it in a second blinded cohort with 13/14 later stage cancers detected with 10 additional controls.
“We have also subsequently reported data from a blinded validation cohort of 81 subjects (colorectal and lung cancer patients = 59, healthy controls = 22) and are extremely encouraged by the results; the early-stage cancer detection of 95% of stage I and II cancers is particularly noteworthy.
“For patients, the potential significance is huge. If validated in larger cohorts, CTCF Capture-Seq™ could contribute to Multi-Cancer Early Detection (MCED) fulfilling a significant unmet clinical need.
“We also believe that Capture-Seq™ has the potential to play a role in cancer management, including but not limited to, Minimal Residual Disease detection and treatment monitoring, either alone or potentially in combination with other technologies too.”
###
- Pamart, D., et al.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. Clin Epigenet (2026). https://doi.org/10.1186/s13148-026-02205-x
- Data on File : Volition TAM Model
