NAMUR, Belgium, Nov. 3, 2016 /PRNewswire/ — VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing diagnostic tests for cancer, today announced its collaboration with Hvidovre Hospital, University of Copenhagen, Denmark in a prospective clinical study of 30,000 patients. This ambitious clinical study signifies Volition’s commitment to the discovery of new cancer blood tests into the middle of the next decade. Pursuant to the terms of the collaboration, Volition has agreed to make payments of 7.5 million Danish Krone (approximately $1.1 million USD) per year for the first two years of the study (Phase I). After the completion of Phase I, Volition may elect to continue with Phase 2 and/or Phase 3 of the study upon payment of 7.5 million Danish Krone annually for up to an additional 4 years.
Under the terms of the study, a total of 90,000 blood samples will be collected from 30,000 patients who have tested negative in a national fecal colorectal cancer screening test. A blood sample will be collected from each patient on three separate occasions at 2-year intervals, and the study will follow his or her progress over time. Volition will test whether, and how early, its Nu.QTM assays detect cancer in samples taken before the definitive diagnosis of colorectal cancer. All blood samples will be accompanied by up to 120 clinical information data points, including life style factors and a wide range of other diseases, allowing Volition to use this study in a wider context for other cancers.
Professor Hans Jorgen Nielsen from Hvidovre Hospital, University of Copenhagen, voiced his support for the study, saying: “We are very pleased to be continuing our work with Volition, especially on a study that is identifying patients who are going undiagnosed under the current screening system. This is an incredibly powerful longitudinal study because we are going to be collecting a huge amount of data over a seven-year period.”
Jake Micallef, PhD, Chief Scientific Officer at Volition said, “We are delighted to be working with the Hvidovre Hospital again. We believe that this is one of the biggest clinical studies ever undertaken. Each sample collected will be sufficient for multiple Nu.QTM tests and the study will form the basis for our product pipeline in multiple cancers for many years to come.”
Dr. Jason Terrell, Volition’s Chief Medical Officer and Head of U.S. Operations, commented: “The study with Hvidovre Hospital can play a major role in the expansion of our clinical development program. Large prospective studies of this quality provide invaluable clinical information. The partnership with Hvidovre Hospital will support our mission to deliver accurate and cost-effective early stage cancer diagnostics.”
Volition and Hvidovre Hospital expect to have initial interim results from this study by the end of 2018. Volition currently has numerous other ongoing studies on its Nu.QTM blood tests, and its first test, the Nu.QTM colorectal cancer triage test, is expected to have a commercial release in early 2017.
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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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” 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 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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