VolitionRx Limited's Novel Cancer Diagnostic Test Achieves CE Marking as it Prepares for Launch Across Europe
NAMUR, Belgium, Jan. 3, 2017 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX) today announced that the Company achieved CE marking on its Nu.QTM Colorectal Cancer Screening Triage Test on December 28, 2016, paving the way for its expected launch across the EU. The novel blood test, developed at Volition's laboratories in Belgium in conjunction with Hvidovre Hospital (University of Copenhagen), has demonstrated the potential to reduce colonoscopies by up to 25% while maintaining almost 97% detection of colorectal cancer when combined with the fecal immunochemical test (FIT) score. The Nu.QTM Triage Test is the first in a pipeline of cancer screening tests that Volition hopes to bring to market.
Speaking about the CE marking, Cameron Reynolds, CEO of Volition said: "This is a very exciting time for Volition as we are coming to market with a product that we believe meets a pressing and immediate need in many European countries. This is easily our biggest achievement yet, and is the result of many years of work from our dedicated team. This milestone signals our transition from a research and development phase to a commercial one."
Louise Day, Volition's Chief Marketing and Communications Officer said, "Being able to offer European healthcare systems a simple and easy to use blood test which can be used to triage FIT positive populations for colorectal cancer has the potential to make a significant difference in many people's lives and to help health care systems better serve patients. We have identified the first wave of European countries for launch and are pleased with the progress we are making."
The most frequently used first line test for colorectal cancer screening across Europe is the FIT test. Patients with a positive score following FIT are then referred for colonoscopy. However, approximately 94.8% of people who test FIT positive do not have colorectal cancer. This means that there are a significant number of unnecessary expensive and invasive colonoscopies performed, placing a severe burden on both the patient and the healthcare system. Now that it has achieved CE marking, European patients with a positive FIT score could subsequently be given the blood-based Nu.QTM Colorectal Cancer Screening Triage Test and then only be referred for colonoscopy if the combined test results indicate that it is necessary; thus potentially reducing colonoscopy referrals by up to 25%.
There are organized colorectal cancer screening programs in 14 of the 28 EU states with a further 10 states offering some form of public or privately accessible screening. Volition has identified the initial target governments for its launch in Europe and then intends to roll out the Nu.QTM test across further territories as part of a five year plan.
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Volition is a life sciences company focused on developing diagnostic tests for cancer. The tests are based on the science of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.
Volition's goal is to make the tests as easy and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. Volition's research and development activities are currently centered in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.
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Media / Investor Contacts
Louise Day, Volition
+44 (0)7557 774620
Scott Powell, Volition
+1 (646) 650 1351
Tirth Patel, Edison Advisors
+1 (646) 653 7035
Rachel Carroll, Edison Advisors
+44 (0)20 3077 5711
Sarah Roberts, Vane Percy & Roberts
+44 (0)1737 821 890
Safe Harbor Statement
Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will," "hopes" and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of the Company's bodily-fluid-based diagnostic tests as well as the Company's ability to develop and successfully commercialize such test platforms for early detection of cancer. The Company's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include the Company's failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in the Company's development pipeline or any other diagnostic products the Company might develop; the Company will face fierce competition and the Company's intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about the Company's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, the Company does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.
Nucleosomics®, NuQ®, Nu.QTM and HyperGenomics® and and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners.
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SOURCE VolitionRx Ltd.
Released January 3, 2017