VolitionRx begins pilot study to assess feasibility of NuQ assays in detecting prostate cancer

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 initiated a pilot study to assess the feasibility of VolitionRx's proprietary NuQ^® assays in detecting prostate cancer. The study is in collaboration with ImmuneHealth, a global biomarker contract research organization (CRO), and is taking place in Belgium.

In the prospective study, 120 blood samples will be collected from patients across four Belgian hospitals and analyzed by Belgium-based ImmuneHealth using VolitionRx's NuQ^® assays, which are based on the Company's proprietary Nucleosomics^® technology. Four groups of patients will be assessed: aggressive prostate cancer, indolent prostate cancer, prostate hyperplasia and negative controls. In addition to determining the test's ability to accurately detect prostate cancer, the study will also assess the tests' ability to distinguish among the different prostate conditions and healthy samples. If the test demonstrates significant accuracy, it could have the potential to become an early-stage screening tool.

VolitionRx Chief Scientific Officer Dr. Jake Micallef commented, "In addition to our anaplastic prostate cancer study in collaboration with MD Anderson, we are now embarking on a pilot diagnostic prostate cancer study with ImmuneHealth of Belgium. While the anaplastic study is aimed at the differential detection of this particularly aggressive form of prostate cancer requiring very aggressive treatment, the ImmuneHealth study will investigate our NuQ^® assays for more general prostate cancer detection. Both early prostate cancer detection and selection of patients for aggressive treatment are critical for improved outcomes, which is why we are launching a second study with ImmuneHealth to further evaluate our NuQ^® assays in this indication. In addition, we are grateful to the Walloon region of Belgium which is covering the majority of the costs of the study."

ImmuneHealth Business and Marketing Director Julien Isoard remarked, "As a global CRO specializing in the clinical support for biomarker panels development, we are committed to facilitating the generation of clinically meaningful data and samples through quality patient cohorts that companies like VolitionRx can use to demonstrate their diagnostics' ability to benefit patients and physicians. Based on the analysis we will conduct, it is our hope that VolitionRx's NuQ^® tests are further evaluated in larger studies that will enable the Company to bring to market a simple, non-invasive and cost-effective blood test to better diagnose patients with prostate cancer."

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 this prostate cancer 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 600 patient prospective confirmatory study in lung cancer 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.
• A 40 patient prospective study with Singapore General Hospital (SGH) to establish the feasibility of VolitionRx's proprietary NuQ® assays in detecting ovarian cancer.