VolitionRx Ltd delighted with European approval for two blood assays


(MENAFN- ProactiveInvestors - N.America) Cancer diagnostics and life sciences group VolitionRx Ltd (NYSE:VNRX) reached yet another milestone - with the award of CE marks for two of its blood-based tests for detecting colorectal cancer.

It means the group can sell three biomarker assays clinically in the 28 member states of the EU as well as Switzerland Turkey Iceland Norway and Liechtenstein- potentially reaching a population of nearly 600mln.

It says it expects to launch a panel test for clinical use in Europe towards the end of 2016.

The assays in question are NuQV001 and NuQT003 which can analyse nucleosomes circulating in blood for the presence of cancer signatures.

It follows VolitionRx's first CE mark in September - for the NuQX001S biomarker assay for detecting colorectal cancer.

VolitionRx plans to sell a test for colorectal cancer consisting of a panel of up to six NuQ biomarker assays that requires only a single drop of blood from patients.

Gaetan Michel the chief executive of Belgian Volition SA said: "In recent months VolitionRx has achieved consistently excellent results for colorectal cancer detection using a panel test of NuQ assays and has successfully detected both early- and late-stage cancer which is critical for improving five-year survival rates.

"Since we announced our first CE marked biomarker assay last September the company has continued its strategic work toward additional CE marking that will allow us to deliver first-class quality products to physicians and their patients.

He added: "The CE marks mean that these NuQ products are compliant with EU legislation and meet EU in-vitro diagnostic medical device requirements for clinical use in the European market."

Cameron Reynolds president and chief executive of the group added: "We are currently in the process of CE marking other assays to finalise the panel for the anticipated European launch of our tests late this year.

"We are also progressing toward our goal of making our assays available for clinical use in the U.S. and the rest of the world.

"Due to the non-invasive low-cost and patient friendly nature of NuQ blood tests we believe our technology has the potential to gain market acceptance and save lives in Europe the US and worldwide."

Today's news follows the recent release of data from a 430-subject trial which demonstrated that the group's blood tests accurately detected 86% of early-stage colorectal cancers at 78% specificity as well as 75% of high-risk colorectal adenomas or pre-cancerous polyps that were most likely to become cancerous.


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