VolitionRx teams up with market access consulting agencies to support access of NuQ cancer tests across Europe

DecideumCogentia to Support UK Access; MedPass to Support Several European Countries

VolitionRx Limited, 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:

Colorectal cancer:

• 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)

Lung cancer:

• A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany)

Prostate cancer:

• 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)
• Ovarian cancer:
• A 40-patient prospective feasibility study (Singapore General Hospital, Singapore)

Endometriosis

• A prospective study to assess VolitionRx’s NuQ^® tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom)