VolitionRx Achieves Breakthrough in Liquid Biopsy with 99% Pure Cancer DNA Isolation
Key Insights
VolitionRx Limited (search) becomes the first company to demonstrate isolation and analysis of over 99% pure circulating tumor-derived DNA from blood plasma, overcoming a major challenge in cancer (search) testing.
The company developed a novel two-step "Capture-Seq" method combining physical enrichment and bioinformatic filtering to isolate virtually pure tumor DNA for liquid biopsy applications.
The breakthrough targets a $36 billion total addressable market in early cancer (search) detection and minimal residual disease monitoring, with the company actively pursuing partnerships with global diagnostic leaders.
VolitionRx Limited (search) has announced what it describes as a scientific breakthrough in liquid biopsy technology, becoming the first company to demonstrate isolation and analysis of more than 99% pure circulating tumor-derived DNA (ctDNA (search)) from blood plasma. The achievement addresses a fundamental challenge in cancer (search) testing where the vast majority of circulating DNA typically comes from healthy cells rather than cancer cells.
The multi-national epigenetics company submitted an updated manuscript detailing its novel approach, which combines physical enrichment with bioinformatic filtering to isolate virtually pure tumor DNA. This two-step method, termed "Capture-Seq," represents what the company believes could be the biggest scientific breakthrough in cancer (search) testing and monitoring in recent years.
Revolutionary Technology Overcomes Key Limitation
Dr. Jake Micallef, Chief Scientific Officer at Volition, explained the significance of the breakthrough: "Distinguishing cancer (search) derived plasma DNA from healthy DNA when the two are mixed is problematic. When the cancer DNA makes up 1% or less of the total DNA it is extremely problematic. Moreover, DNA from cancer and healthy cells has the same double helix structure and has never before been separated chemically."
The company's research revealed that there is almost no CTCF (search)-bound DNA in healthy plasma, while almost all CTCF-bound DNA in the blood of cancer (search) patients is derived from cancer cells. This discovery enabled the development of their unprecedented purification method.
"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," Micallef noted. "I believe this is a world-first and could, in my opinion, represent the biggest scientific breakthrough in cancer (search) testing and monitoring in recent years."
Clinical Validation Shows Promise
The clinical validation results demonstrate the technology's potential effectiveness. Dr. Andrew Retter, Medical Consultant at Volition, reported encouraging proof of concept and early blinded validation results: "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."
The company is currently working on further validation cohorts of early stage cancers, with additional data expected soon. If validated in larger cohorts, CTCF (search) Capture-Seq could contribute to multi-cancer (search) early detection and disease management, particularly in combination with Volition's existing Nu.Q (search)® assay for lung cancer (search).
Significant Commercial Opportunity
Gael Forterre, Chief Commercial Officer at Volition, highlighted the commercial potential of the breakthrough technology. The company estimates a total addressable market of approximately $23 billion annually for human multi-cancer (search) early detection (MCED) applications and over $13 billion for minimal residual disease (MRD) detection.
"This scientific breakthrough has generated a lot of interest with potential licensing partners," Forterre stated. "We feel that this technology could, with further development, become very widely used, in both the human and potentially the veterinary market, not only for multi-cancer (search) early detection but also the detection of Minimal Residual Disease."
Active Partnership Discussions
VolitionRx is currently in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development and launch of this technology. The company has filed multiple new patents to protect the Capture-Seq technology and its applications.
The breakthrough technology shows potential for both standalone multi-cancer (search) early detection approaches and combination strategies with other tests. Volition's focus on circulating cell-free nucleoproteins represents a novel approach in the liquid biopsy field.
Market Response
The announcement generated significant investor interest, with VolitionRx shares surging 37.59% to $0.2628 on the New York Stock Exchange. Trading volume reached approximately 203.45 million shares, substantially above the average volume of about 2.02 million shares, reflecting strong market enthusiasm for the breakthrough.