DecideumCogentia to Support UK Access; MedPass to Support Several European Countries
NAMUR, Belgium, June 23, 2015 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced that it has established partnerships with two prominent market access consulting agencies, DecideumCogentia and MedPass International, to support market access of its NuQ® cancer tests across Europe. Under the agreements, DecideumCogentia will provide strategy and counsel for the Company in gaining entry for its colorectal cancer detection test into the United Kingdom (UK) market, while MedPass will support the tests' entry into the rest of Europe, initially providing advice on the optimum countries to target for initial roll out. Market access strategy and counsel from both firms will include pricing and reimbursement research, exposure to key opinion leaders, and budget models for individual countries.
Cameron Reynolds, Chief Executive Officer of VolitionRx, commented, "Gaining CE Mark followed by market access into European countries for our NuQ® colorectal cancer test is one of our key corporate goals for the next 12 months. To maximize our ability to achieve seamless and optimal entry, pricing and reimbursement, we have established a relationship with Decideum and its partner Cogentia Healthcare Consulting to identify the best path forward to penetrate the UK market and facilitate the tests' uptake by physicians and hospitals once approved. For the rest of Europe, MedPass International will provide strategic guidance for entry into multiple markets, with an emphasis on each country's particular economic and regulatory policies. We look forward to forming strong relationships, executing seamless market entry and ultimately driving sales of our NuQ® tests that have the potential to revolutionize cancer detection and diagnosis."
The NuQ® tests utilize the Company's proprietary Nucleosomics® technology platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer and signals within the blood. NuQ® is currently under clinical investigation, and results from several large ongoing trials will provide the basis for application to the European Medicines Agency (EMA) for CE Mark, the European equivalent of the FDA approval in the US. Obtaining a CE mark for our products would allow the Company to sell clinically in all 28 countries in the EU and assist with rollout in other developing nations.
Decideum Ltd. Managing Director Berkeley Greenwood said, "VolitionRx offers a differentiated product in the NuQ® assays' ability to detect colorectal cancer at early stages of disease and as a cost effective simple blood test, it has the potential to improve compliance, thereby saving lives and money for healthcare systems. We look forward to partnering with VolitionRx to support its strategic market access into the UK."
MedPass International Market Access and Reimbursement Director Sylvia Germain added, "Market access and optimal reimbursement are critical considerations that require careful planning and strategic execution in the European Union given the diversity of the region's governments, payers and regulating healthcare organizations. As VolitionRx's counsel for access into several European countries, we will develop a reimbursement roadmap outlining specific aspects in each of the target countries and potential actions to optimize market access and provide value for investors."
Clinical trials assessing the effectiveness of VolitionRx's assays include:
- A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark)
- A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen, Denmark)
- A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium)
Pre-cancerous colorectal adenomas:
- A 800 patient prospective study (Hvidovre Hospital, University of Copenhagen, Denmark)
- 27 most prevalent cancers
- A 4,200 patient prospective study that involves patients with the 27 most prevalent cancers (University Hospital, Bonn, Germany)
- A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany)
- A retrospective study to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas)
- A 120-patient prospective feasibility study (ImmuneHealth, Belgium)
- A 40-patient prospective feasibility study (Singapore General Hospital, Singapore)
- A prospective study to assess VolitionRx's NuQ® tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom)
VolitionRx is a life sciences company focused on developing diagnostic tests for cancer and other conditions. 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.
VolitionRx's goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx'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 US and ultimately, worldwide.
Charlotte Reynolds, VolitionRx
Telephone: +44 (0) 795 217 7498
Kirsten Thomas, The Ruth Group
Telephone: +1 (646) 536-7014
Scott Powell, VolitionRx
Telephone: +1 (646) 650-1351
Lee Roth, The Ruth Group
Telephone: +1 (646) 536-7012
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," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests" 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 Report 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.
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SOURCE VolitionRx Ltd