Key Highlights
- VolitionRx (VNRX) shares climbed more than 70% during pre-market hours Wednesday
- The biotech firm achieved isolation of over 99% pure circulating tumor DNA (ctDNA) from patient blood samples
- Its proprietary Capture-Seq™ technology employs a dual-step approach merging physical enrichment with advanced bioinformatics
- Blinded testing revealed 49/49 successful cancer identifications in one study group, plus 13/14 in another cohort
- VolitionRx estimates a total addressable market approaching $36 billion and is pursuing licensing partnerships
Shares of VNRX experienced a dramatic surge exceeding 70% in Wednesday’s pre-market session following VolitionRx’s announcement of what the company characterized as a significant breakthrough in liquid biopsy diagnostics.
The biotechnology company revealed it had achieved successful isolation of circulating tumor-derived DNA (ctDNA) from patient blood samples at purity levels surpassing 99%. This advancement means virtually all non-cancerous DNA fragments were eliminated, producing an exceptionally clean tumor DNA specimen.
Liquid biopsy technology has long faced a fundamental obstacle: the vast majority of cell-free DNA circulating in blood originates from normal, healthy cells rather than malignant ones. Extracting a clear cancer signal from this background noise has proven exceptionally challenging. VolitionRx claims its innovative approach overcomes this barrier.
The company’s Capture-Seq™ methodology operates through a dual-phase process. Initially, it performs physical enrichment of the sample. Subsequently, sophisticated bioinformatics algorithms eliminate remaining background interference. According to VolitionRx, this produces a dataset with greater than 99% ctDNA purity.
Jake Micallef, the company’s Chief Scientific Officer, described the achievement as “a world-first.” He explained that CTCF-bound DNA — the particular DNA biomarker this technology isolates — shows minimal presence in plasma from healthy individuals but appears almost exclusively as cancer-derived material in cancer patients.
“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 stated in the company’s announcement.
Blinded Study Performance Data
VolitionRx disclosed findings from two separate blinded cohort investigations. The first trial successfully identified all 49 cancer cases tested. The second study detected 13 cancers out of 14 samples.
These figures represent preliminary-stage data, and the study populations remain relatively limited. More extensive clinical trials will be required prior to any potential commercial launch. Additionally, the technology captures only a specific fraction of ctDNA, meaning certain tumor DNA fragments may escape detection.
The company has submitted a revised manuscript to Research Square, a preprint repository. The research has not yet completed peer review, which represents a critical validation step before findings gain acceptance within the wider scientific establishment.
Commercial Opportunity and Market Outlook
VolitionRx referenced a combined addressable market opportunity valued at roughly $36 billion, encompassing both multi-cancer early detection (MCED) applications and minimal residual disease (MRD) surveillance.
According to the company, it is presently engaged in ongoing conversations with prospective diagnostic licensing collaborators. No formal agreements have been disclosed to date.
VNRX shares appeared positioned to finish above their 100-day moving average for the first occasion since October 8, 2025, assuming pre-market momentum sustained through regular trading hours.
The revised preprint manuscript is anticipated to appear on Research Square in the near term, per company statements.
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