The study describes Capture-Seq, a method that isolates more than 99% pure circulating tumor-derived DNA from plasma by targeting transcription factor-protected DNA fragments.
VolitionRx Limited announced the publication of a peer-reviewed paper detailing its Capture-Seq technology, which demonstrates the isolation of more than 99% pure circulating tumor-derived DNA (ctDNA).
The study, titled “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,” describes a method to overcome the high levels of healthy background DNA typically found in blood plasma. Most current liquid biopsy methods rely on deep sequencing of plasma DNA, but the majority of circulating DNA in these samples usually originates from healthy cells rather than cancer cells.
The new technology uses a two-step method to isolate DNA bound to the CTCF transcription factor. According to the company, research has revealed that there is almost no CTCF-bound DNA in healthy plasma, while nearly all CTCF-bound DNA in the blood of a cancer patient is derived from tumor cells.
“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,” says Jake Micallef, chief scientific officer at Volition, in a release.
The published paper reports results from two independent cohorts. In the first cohort, the technology detected 49 out of 49 cancers, including 23 stage I and II cases, with no false positives. A second blinded cohort detected 13 out of 14 later-stage cancers. The company also reported data from a subsequent blinded validation cohort of 81 subjects, which showed a 95% detection rate for stage I and II cancers.
“From a clinical perspective, the proof of concept and early blinded validation results reported in this paper are extremely encouraging,” says Andrew Retter, medical consultant at Volition, in a release. “If validated in larger cohorts, CTCF Capture-Seq could contribute to multi-cancer early detection fulfilling a significant unmet clinical need.”
The company is developing the technology for both multi-cancer early detection and minimal residual disease monitoring. Volition is currently conducting further studies with larger sample sets and is in discussions with diagnostic companies regarding technical evaluations and potential licensing.
“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 billion for the human multi-cancer early detection use and over $13 billion for minimum residual disease,” says Gael Forterre, chief licensing officer at Volition, in a release.
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