VolitionRX to initiate NuQ blood-based tests in colorectal cancer clinical trial

VolitionRX Limited, a life sciences company focused on developing blood-based diagnostic tests, announces that its subsidiary Belgian Volition has signed an agreement with the Biobank of CHU UCL Mont-Godinne, an academic hospital in Yvoir, Belgium. This is the fourth large-scale external clinical trial for VolitionRX. The trial will begin in early September, and is scheduled for completion next year. The trial will be a prospective longitudinal study including approximately 250 patients as they progress through diagnosis and treatment. The project aims to develop and clinically evaluate non-invasive blood tests for early detection and prognosis of colorectal cancer.

Patient recruitment and sampling will take place in the Gastro-Enterology and Oncology Departments of the CHU UCL Mont-Godinne Hospital. Patients with a potential digestive pathology (including a mixture of suspected colorectal cancer, polyp, inflammatory bowel disease ("IBD"), Crohn's disease and colitis) will be given a blood test alongside a colonoscopy. Samples will be taken from the following cohorts:

• Patients with positive colonoscopy for IBD or polyp: initial sample plus a follow-up blood test
• Patients with positive colonoscopy for cancer, and treated as follows:
  • Surgery only: initial samples followed by a further blood sample approximately one month after surgery;
  • Surgery followed by chemotherapy: initial sample followed by further samples pre and post chemotherapy treatment rounds;
  • Chemotherapy followed by surgery: initial sample followed by further samples pre and post chemotherapy treatment rounds and surgery;
• Patients with negative colonoscopy for IBD, polyp or cancer will form an age-matched healthy control cohort.

Belgian Volition will analyze the samples using its NuQ™ kits, at its laboratory in Namur, Belgium.

Jake Micallef, Chief Scientific Officer of Belgian Volition says: "This clinical trial will be our first validation study of our NuQ blood-based tests specifically on a single cancer – colorectal cancer, which is one of the most prevalent cancers, both in Belgium and worldwide. Our aim is to distinguish between patients with cancer and those with digestive conditions presenting with similar symptoms."

Cameron Reynolds, President & CEO of VolitionRX says: "We're extremely grateful to the Walloon Region of Belgium for their support and funding, which will assist us in carrying out this study into colorectal cancer. We are pleased to be working with another first-class hospital to validate our tests – ensuring that sample collection takes place exactly as it will would be when clinically available."