Clinical study results of VolitionRx's NuQ test for pancreatic cancer published in Clinical Epigenetics

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Reviewed

Oct 14 2015

Non-invasive Blood-based Test Shown to Detect 92% of Pancreatic Cancer Cases in Samples from 59 Individuals

VolitionRx Limited (NYSE MKT: VNRX) today announced that full results from a completed clinical study of its NuQ^® blood-based test for early stage pancreatic cancers have been published in the online issue of Clinical Epigenetics, the official journal of the Clinical Epigenetics Society. The peer-reviewed study was conducted in collaboration with Lund University, Sweden, and led by Roland Andersson, MD, PhD, Professor of Surgery and Vice-Dean, Faculty of Medicine.

The study assessed blood samples from 59 individuals, including 25 patients with stage 2 pancreatic cancer, 10 patients with other pancreatic diseases and 24 healthy individuals, using VolitionRx's Nucleosomics^®technology platform. Analysis of the blood samples demonstrated that a panel of five NuQ^® assays distinguished 84% (21 of 25) of the early-stage pancreatic cancer cases from healthy subjects, with only two false positive results among the healthy subjects. The detection rate of the test was improved further to 92% (23 of 25) of cancer cases by inclusion of the classical CA19-9 cancer biomarker with no false positives results among the healthy subjects. Full details are available in the publication: http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf

This is the first peer reviewed validation of VolitionRx's panel approach to diagnostic test development.

Pancreatic cancer is one of the most deadly cancers. There are more than 40,000 deaths and over 50,000 new cases diagnosed each year in the U.S. alone. In addition, pancreatic cancer is projected to become the second leading cause of cancer-related death in the U.S. by 2030. Pancreatic cancer is difficult to detect and diagnose because there aren't any noticeable signs or symptoms in the early stages of pancreatic cancer. The signs and symptoms of pancreatic cancer, when present, are like the signs and symptoms of many other illnesses. The five-year survival rate for pancreatic cancer is currently just 7%. However, these cancers are typically detected at late-stage after the onset of symptoms. VolitionRx believes that there remains a high unmet medical need for tests that detect early-stage cancer and are also non-invasive and easy to use.

VolitionRx Chief Executive Officer Cameron Reynolds, commented:

This is a very important milestone for VolitionRx. To our knowledge, this study is the first to describe the epigenetic profiling of nucleosomes circulating in the blood for the detection of pancreatic cancer, making its publication a significant achievement in the field of blood-based cancer detection. These results demonstrate that our NuQ^® tests can accurately and distinctly detect differing levels and epigenetic profiles of nucleosomes in the blood of patients with pancreatic cancer, and differentiate those from healthy populations as well as those with other benign pancreatic diseases. Furthermore, the study confirms nucleosome profiles as distinguished by our NuQ^® tests represent potential biomarkers for the early detection of cancer with very good accuracy. We are in the process of negotiating large trials to confirm these extremely encouraging results from this pilot study.

Dr. Roland Andersson, MD, PhD, Professor of Surgery Vice Dean, Faculty of Medicine at Lund University, Sweden, added:

Pancreatic cancer has a poor prognosis, with a five-year survival rate of only 6-7 percent, mainly due to the asymptomatic nature of its early stages, aggressive biological behavior, and limitations of current detection technologies. Our pilot study shows that VolitionRx's NuQ^® blood-based diagnostic tool accurately detects and distinguishes patients with pancreatic cancer from those with benign cases and from healthy patients. On a practical level, these are tests that use a single, small volume of blood and have potential as a valuable screening option, as the test is able to detect with high sensitivity even early stages of disease.

VolitionRx Chief Scientific Officer Dr. Jake Micallef said:

The complete dataset confirms the significant clinical accuracy for our NuQ^® assays in detecting pancreatic cancer and futher validates nucleosomes as biomarkers with their rich variety of available epigenetic features that allow for fine-tuning of sensitivity and specificity. In addition, the study showed that the assays' accuracy could be further improved by combining VolitionRx's nucleosome biomarkers with the well-established CA19-9 biomarker, considered the benchmark to which all new investigational biomarkers are compared, to produce highly specific, clinically-sensitive biomarker panels.

The NuQ^® tests utilize the Company's proprietary Nucleosomics^® platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer and signals within the blood.

In addition to the published data from the study evaluating NuQ^® in pancreatic cancer, 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 retrospective 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