VolitionRx Limited disclosed a 180‑fold (18,000%) enrichment of transcription‑factor‑bound cell‑free DNA in plasma using its Capture‑Seq™ platform, a first‑of‑its‑kind result that could dramatically improve the sensitivity and cost‑effectiveness of liquid‑biopsy cancer tests.
The breakthrough was demonstrated in a training cohort of 70 individuals, including 49 cancer patients with breast, prostate, lung, and colorectal disease. In this cohort the assay detected all cancer cases with 100 % sensitivity and 100 % specificity, including early‑stage patients. By physically isolating ultrashort DNA fragments bound to transcription factors, the technology removes 99 % of background DNA, potentially reducing sequencing costs and enabling rapid, low‑cost diagnostics.
VolitionRx estimates that the technology could open a $23 billion addressable market for early cancer detection and monitoring. The company stresses that the preprint findings must be confirmed in larger, independent validation studies, and it is actively pursuing licensing or distribution agreements with larger diagnostics or pharmaceutical partners to accelerate commercialization.
In its most recent quarterly report, VolitionRx reported revenue of $0.6 million, a 32 % year‑over‑year increase, but a net loss of $0.05 per share, missing consensus estimates of $0.0375. The revenue miss reflects limited commercial sales in the early‑stage product pipeline, while the loss is driven by ongoing investment in research and development and cost control measures that have not yet translated into profitability.
Dr. Jake Micallef, Chief Scientific Officer, said the breakthrough “represents the biggest scientific advance in cancer testing in recent years” and highlighted the 180‑fold enrichment and >99 % background removal. Chief Commercial Officer Gael Forterre noted that the assay “detected all patients with cancer, including early‑stage disease, with 100 % sensitivity and specificity” and emphasized the need for larger validation studies to confirm the findings.
The company’s financial statements reveal a cautious outlook: while revenue growth is modest, operating expenses have been reduced by 10 % year‑on‑year, and management is focused on securing strategic partnerships to offset the current loss. VolitionRx’s preprint status and the requirement for independent validation underscore the importance of continued investment and partnership development to translate the breakthrough into a commercially viable product.
The announcement has been well received by investors, reflecting confidence in the technology’s potential to transform liquid‑biopsy diagnostics, but the company’s ongoing financial challenges and the need for further validation remain key considerations for stakeholders.
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