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www.fdanews.com/articles/173224-volitionrx-receives-ce-mark-for-assay-detecting-colorectal-cancer

VolitionRx Receives CE Mark for Assay Detecting Colorectal Cancer

September 22, 2015

Belgium-based VolitionRx Limited has received its first CE Mark for its NuQ X001S blood-based diagnostic assay, which tests for detection of colorectal cancer.

The assay identifies and analyzes fragments of chromosomes circulating within blood for the presence of epigenetic cancer signals by utilizing the company’s Nucleosomics technology platform.

A 4,800-subject trial of the test detected 81 percent of colorectal cancers at 78 percent specificity equally well for both for early- and late-stage cancers. It also found 63 percent of potentially pre-cancerous adenomas and 67 percent of high-risk adenomas.

VolitionRx anticipates launching the assays for clinical use in Europe during 2016. — Michael Cipriano