Study shows effectiveness of VolitionRx’s NuQ test in detecting lung cancer in blood and sputum

VolitionRx Limited (OTCQB: VNRX), a life sciences company focused on developing diagnostic tests for cancer and other conditions, today announced that data from its pilot lung cancer study will be presented at the Science for Business BioWin Day 2014, being held November 26, 2014 in Louvain-la-Neuve, Belgium. The data come from VolitionRx’s lung cancer pilot study, the samples for which were collected at the Pneumology department of the Centre Hospitalier Universitaire (CHU) de Liège in Belgium. The study assessed the ability of VolitionRx’s proprietary NuQ^® platform to detect lung cancer in both blood and sputum (airway secretions, or mucus coughed up from the lower respiratory tract).

VolitionRx lead scientist Marielle Herzog, Ph.D., will present the lung cancer data during the meeting’s “Company Presentations” session from 2:00 – 3:30 p.m. CET. BioWin Day is the international networking event that BioWin, the Health Cluster of Belgium’s Wallonia region, organizes once every two years, and the only formal event that gathers stakeholders active in the health, biotechnologies and medical technologies sector in Wallonia.

Currently, most lung cancers are first diagnosed based on symptoms, which generally reflect damage to the lungs’ ability to function normally. Unlike mammography for breast cancer or colonoscopy for colorectal cancer, a screening tool for early-stage lung cancer is not available beyond the American Society of Clinical Oncology’s (ASCO) guidelines suggesting annual screening with a low-dose computed tomography scan (LDCT) for individuals at high risk for lung cancer. A simple, accurate, cost-effective test could help detect lung tumors in their earliest stages, when many physicians believe the tumors are most curable.

VolitionRx’s prospective study tested both blood and sputum samples from 46 individuals with either non-small cell lung cancer, chronic obstructive pulmonary disease (COPD) or with no disease (healthy) across various NuQ^® assay panels.

In sputum samples, the analysis demonstrated that VolitionRx’s NuQ^® test was able to detect 18 of 21 lung cancer cases (85%) with no false positive results for healthy subjects (0 of 13). Furthermore, NuQ^® assays were able to discriminate lung cancer from COPD, another important respiratory disease linked to habitual smoking. The sputum assay data is age and smoking independent.

In blood samples from the same patients adjusted for age and smoking risk, the NuQ^® assays were able to detect 16 of the 21 patients with cancer (76%) with a single false positive result for a healthy subject (1 of 13). This test was also able to discriminate lung cancer from COPD.

Overall, the technology in both blood and sputum samples appeared to detect both early and late stage lung cancer with high sensitivity and specificity, but further research with a larger number of samples is required to confirm this outcome.

Chief Scientific Officer Dr. Jacob Micallef, Ph.D., remarked:

Detection of lung cancer is a huge unmet medical need, so these data demonstrating, in a small number of subjects, that our NuQ^® assays are able to detect lung cancer with high accuracy are extremely promising. Furthermore, this research showing NuQ^® tests work both in blood and airway secretions demonstrates for the first time that the Nucleosomics^® technology is useful in a body fluid other than blood, greatly extending its potential applications. We look forward to continuing to develop and evaluate our assays for lung cancer in larger trials that we are currently negotiating.

Head of the Pneumology Department, CHU Liège, Pr Renaud Louis said:

These data appear to be very promising as the NuQ^® test not only differentiated lung cancer from healthy subjects but also from COPD, another disease related to tobacco consumption in which oxidative stress is supposed to play a major role. On the other hand I find it very interesting that analysis of airway secretion sampled by a non-invasive method may yield such a sensitivity and specificity in lung cancer detection.

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, and now within sputum.

In addition to this study, other clinical trials assessing the effectiveness of VolitionRx’s assays include:

• A 4,800 patient retrospective symptomatic population study in colorectal cancer at Hvidovre Hospital, University of Copenhagen, Denmark
• A 14,000 patient prospective screening study in colorectal cancer at Hvidovre Hospital, University of Copenhagen, Denmark
• A 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn, Germany
• A 250 patient prospective study in colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium
• A retrospective study with MD Anderson, Texas, 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.
• A prospective study with the University of Oxford, United Kingdom, to assess VolitionRx’s NuQ^® tests for the diagnosis of endometriosis.