NuQ Blood Assay CE-Marked for Colorectal Cancer Detection

A blood-based diagnostic assay for detection of colorectal cancer has received Conformité Européenne (CE) marking, which enables European Clinical Use/Sale in 33 Countries with nearly 600 million people.

The test utilizes a proprietary technology platform that identifies and analyses fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of epigenetic cancer signals.

The announcement of the CE marking follows the presentation earlier this month of interim data of a 4,800-subject trial, which demonstrated that the NuQX001S (VolitionRx Limited; Namur Belgium) 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. The NuQ test utilizes the Company's proprietary Nucleosomics technology platform.

The Company plans to offer a commercial test consisting of a panel of four to six individual enzyme-linked immunosorbent assays (ELISA); 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.

Gaetan Michel, PhD, CEO of Belgian Volition SA, commented, “Our recent results showed that a panel test of four NuQ assays successfully detected both early- and late-stage cancer well, which is critical for improving five-year survival rates. Achieving the first CE mark for our NuQX001S diagnostic assay demonstrates VolitionRx's clear commitment to deliver these first-class quality products to physicians and their patients.”

Cameron Reynolds, MBA, president and CEO of VolitionRx, said, “We are now able to sell this assay clinically in the 28 member states of the European Union, as well as Switzerland, Turkey, Iceland, Norway, and Liechtenstein, an area with a total population of nearly 600 million people including over 150 million of screening age.”

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