Blinded validation data presented at ESMO MAP demonstrated high sensitivity for stage I and II solid cancers using novel circulating nucleoprotein liquid biopsy technology.
VolitionRx Limited presented clinical data showing early-stage solid cancer detection using its Capture-Seq liquid biopsy technology, according to a company press release regarding its abstract presented at the European Society of Medical Oncology Molecular Analysis for Precision Oncology (ESMO MAP) Conference in London.
The presentation detailed direct chromatin immunoprecipitation sequencing of short CCCTC-binding factor (CTCF)-protected plasma circulating tumor DNA (ctDNA) to identify early-stage solid malignancies.
According to the company, the method was evaluated across two independent cohorts with no false positives reported. In the first cohort, the assay detected 49 of 49 cancers, which included 23 stage I and stage II cases alongside 21 healthy controls. A second blinded cohort validated the platform by identifying 13 of 14 later-stage cancers alongside 10 healthy controls, according to the release.
Volition also reported data from an additional blinded validation cohort of 81 subjects, including 59 colorectal and lung cancer patients and 22 healthy controls. In that cohort, the assay achieved a 95% detection rate in stage I and II cancers, according to the company.
“From a clinical perspective, the proof of concept and early blinded validation results reported are extremely encouraging,” says Andrew Retter, medical consultant at Volition, in a release. “For patients, the potential significance is huge. If validated in larger cohorts, CTCF Capture-Seq could contribute to multi-cancer early detection fulfilling a significant unmet clinical need.”
Retter noted that the assay could also serve applications across oncology care pathways, including minimal residual disease testing and longitudinal treatment monitoring, either as a standalone diagnostic or alongside complementary platforms, according to the release.
Isolating CTCF-Protected Biomarkers
The technical method isolates CTCF-protected plasma ctDNA from background cell-free DNA bound to nucleosomes, according to the company. Sequencing the isolated ctDNA produced distinct data profiles in blood samples from early-stage cancer patients that were entirely absent in healthy controls, according to the presentation data.
“These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers,” says Jake Micallef, chief scientific officer at Volition, in a release. “Capture-Seq shows potential for both a multi-cancer early detection approach, either alone or in combination with other tests, and the detection of minimal residual disease.”
Next Steps in Assay Development
Multi-cancer early detection and liquid biopsy assays remain an active focus for clinical laboratories seeking noninvasive tools capable of differentiating malignant disease from non-cancerous conditions at earlier, more treatable stages.
Volition stated in the release that it is fast-tracking assay development by initiating additional clinical studies that incorporate competing medical conditions, collaborating with oncology key opinion leaders, and filing patents covering the cell-free nucleoprotein isolation and sequencing technology.
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