NuQ diagnostic assay has received European CE mark approval for detection of colorectal cancer- VolitionRx

VolitionRx Limited announced the Company's first CE Mark for its blood-based diagnostic assay, NuQ X001S, for detection of colorectal cancer. The NuQ X001S 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.

Interim data from a 4,800-subject trial 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, which are the most likely to become cancerous.