VolitionRx announced that the company's first CE mark for its blood-based diagnostic assay, NuQX001S, for detection of colorectal cancer.
The NuQ test utilizes the Company’s proprietary Nucleosomics technology platform, which identifies and analyses fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of epigenetic cancer signals.
The NuQX001S assay is the first to be CE Marked out of a suite of NuQ assays developed by VolitionRx targeting different epigenetic modifications that indicate that cancer is present.
The Company plans to offer a commercial test consisting of a panel of 4-6 individual ELISA assays; it is currently conducting ongoing clinical trials and following the CE compliance process on further assays in order to refine the make-up of the panel and produce the highest accuracy detection rates.
VolitionRx anticipates launching its panel of CE Marked assays for clinical use in Europe during 2016.
This announcement follows the presentation earlier this month of interim data of a 4,800-subject trial, which demonstrated that VolitionRx’s NuQ blood tests detected 81% of colorectal cancers at 78% specificity equally well for both for early- and late-stage cancers, as well as 63% of potentially pre-cancerous adenomas and 67% of high-risk adenomas – the most likely to become cancerous.
Gaetan Michel, PhD, Chief Executive Officer of Belgian Volition SA, commented, "Our recent results showed that a panel test of 4 NuQ assays successfully detected both early- and late-stage cancer well, which is critical for improving five-year survival rates."
Cameron Reynolds, President and Chief Executive Officer of VolitionRx added, "This is yet another very important milestone for the Company on our path to making our blood tests available to patients."
VolitionRx currently has several ongoing clinical trials assessing the effectiveness of its NuQ assays.