VolitionRx Limited, a life sciences company focused on developing blood-based diagnostic tests, has signed an agreement with Hvidovre Hospital, University of Copenhagen, Denmark, for two colorectal cancer (CRC) clinical trials. The trials will analyze blood samples from approximately 10,800 patients, using VolitionRx’s proprietary NuQ tests.
The two trials are: Retrospective Study - Volition will analyze samples collected in 2010-2012 of approximately 4,800 patients with colorectal cancer, other malignancies, polyps or adenomas, and benign bowel diseases all of whom have undergone a colonoscopy; with full access to all national registries and databases (electronic audit). The trial will commence in June 2013 with a pilot study of 1,000 of these samples; Prospective Study, to be sponsored jointly by VolitionRx, a top-10 global diagnostics company and the University of Copenhagen: Collection is due to commence in Denmark in April 2014 for a 6,000 patient colorectal cancer screening population trial.
The patient blood samples to be analyzed during the trial have been and will be collected under the direction of Professor Hans Jørgen Nielsen, Professor of Surgical Oncology at the Department of Surgical Gastroenterology at Hvidovre Hospital, part of the University of Copenhagen. They will be provided to VolitionRx blinded and randomized.
Professor Nielsen said: "I am more than happy to provide the samples I have collected over the past two years for this valuable CRC retrospective trial, and I hope that the forthcoming prospective screening study will assist Volition in the development of such an important new technology for early stage cancer detection."
Dr Jake Micallef, chief scientific officer of VolitionRx, says: "Professor Nielsen’s team has collected a high quality bank of blood samples with detailed associated medical histories, taken from patients according to strict Standard Operating Procedures optimized over a number of years. Following our analysis of the blood samples, on a randomized and anonymized basis, we will analyze our results in relation to colonoscopy findings as well as a variety of medical history and other factors, to demonstrate the performance of simple NuQ blood tests in relation to the invasive and expensive current diagnostic gold standard."
VolitionRx is developing blood based diagnostic tests for different types of cancer, based on the science of Nucleosomics: the practice of identifying and measuring nucleosomes in the bloodstream – an indication that cancer is present. The Hvidovre Hospital trial data, once complete, will be used to apply for a CE mark for a colorectal cancer test, and will also be submitted to the FDA. The retrospective samples are being provided to VolitionRx free of charge, while the company is expected to pay approximately $1.8 million towards collection of the prospective samples.
Colorectal cancer is the third most prevalent cancer worldwide, after lung and breast cancers, with approximately 1.24 million new cases diagnosed each year. In the United States alone, 136,717 people were diagnosed with colorectal cancer in 2009, with 51,848 dying from the disease that year.
VolitionRx is a life sciences company whose goal is to make its non-invasive blood tests for cancer as common and simple to use as existing diabetic and cholesterol tests on similar formats.