VolitionRx Accelerates Clinical Trial with University Hospital Bonn, Germany Evaluating NuQ® Assays in Most Prevalent Cancers

Study expanded to evaluate VolitionRx's proprietary Nucleosomics® platform in 4,200 patient samples across 27 of the most prevalent cancers

Sample collection nearly complete, accelerated analysis to begin in early Q3 2015 with dedication of two automated robots

NAMUR, Belgium, May 8, 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 accelerated its large independent prospective study evaluating its proprietary Nucleosomics® platform at University Hospital Bonn in Germany. VolitionRx has dedicated two of its recently-procured Tecan EVO200 automated laboratory robots to the study, with sample analysis to begin early in the third quarter of 2015. In addition, VolitionRx and study lead Prof. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn in Germany have increased the sample size and breadth of cancer types being tested.

The study initially included 4,000 patient blood samples across 20 of the most prevalent cancer types, and has now been expanded to include approximately 4,200-patient blood samples across 27 of the most prevalent cancers, including: two types of respiratory cancer, seven types of gastrointestinal cancer, four gynecological cancers, four urinary cancers, four types of hematological cancer, plus melanoma, sarcoma and cancers of the thyroid and brain; as well as control patients with 24 other conditions and healthy individuals. In total, the cancer types being analyzed represent over 95% of the incidence of cancer.

Dr. Jake Micallef, VolitionRx's Chief Scientific Officer, said, "This trial is an incredibly important one, which we hope will show the breadth of our Nucleosomics® technology. The trial is not only essentially 27 pilot studies in the most common cancers, but we are also looking for differences between cancers, and between cancers and other diseases, to discover if a panel of assays can detect several cancers from the same blood draw. We are grateful to Prof. Holdenrieder for his commitment to this ongoing multi-year trial, demonstrated by the increase of sample size and broadening of cancer types being evaluated in the trial – both of which we hope will enable us to more clearly demonstrate accuracy rates of our NuQ® test in these patient populations."

Cameron Reynolds, Chief Executive Officer of VolitionRx, commented, "We are very excited that with the addition of two fully-operational automated robot systems, analysis of the full 4,200 sample collection is on track to begin early in the third quarter of 2015. We expect to analyze the samples with up to 10-15 NuQ® assays by the first quarter of 2016. The aim of the trial is both to evaluate a large number of cancers and to look for a panel of assays that can diagnose multiple cancers for potential new products beyond the current four cancers we are evaluating."

Prof. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn in Germany, who is leading the study, added, "Collectively, cancer is one of the foremost causes of mortality around the world and there remains a significant global need for improved early cancer detection. An accurate and non-invasive test using only a drop of blood that could detect a range of cancers would provide physicians and patients an opportunity to treat the disease early on, before the cancer metastasizes, providing greater chances of survival. Collection and analysis of samples has been, and will continue to be, carried out in my laboratory with VolitionRx providing the assays for analysis. I am very much looking forward to seeing the results from this study."

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.

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)

About VolitionRx

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.

Visit VolitionRx's website (http://www.volitionrx.com) or connect with us via Twitter, LinkedIn, Facebook or YouTube.

Media Contacts

Charlotte Reynolds, VolitionRx
Charlotte.Reynolds@volitionrx.com  
Telephone: +44 (0) 795 217 7498

Kirsten Thomas, The Ruth Group
kthomas@theruthgroup.com  
Telephone: +1 (646) 536-7014

Investor Contacts

Scott Powell, VolitionRx
S.Powell@volitionrx.com
Telephone: +1 (646) 650-1351

Lee Roth, The Ruth Group
lroth@theruthgroup.com
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

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