VolitionRx Limited, a life sciences company, announced its collaboration with Hvidovre Hospital, University of Copenhagen, Denmark in a prospective clinical study of 30,000 patients. This ambitious clinical study signifies Volition's commitment to the discovery of new cancer blood tests into the middle of the next decade.
Pursuant to the terms of the collaboration, Volition has agreed to make payments of 7.5 million Danish Krone (approximately $1.1 million USD) per year for the first two years of the study (Phase I). After the completion of Phase I, Volition may elect to continue with Phase 2 and/or Phase 3 of the study upon payment of 7.5 million Danish Krone annually for up to an additional 4 years.
Under the terms of the study, a total of 90,000 blood samples will be collected from 30,000 patients who have tested negative in a national fecal colorectal cancer screening test. A blood sample will be collected from each patient on three separate occasions at 2-year intervals, and the study will follow his or her progress over time. Volition will test whether, and how early, its Nu.Q assays detect cancer in samples taken before the definitive diagnosis of colorectal cancer. All blood samples will be accompanied by up to 120 clinical information data points, including life style factors and a wide range of other diseases, allowing Volition to use this study in a wider context for other cancers.
Professor Hans Jorgen Nielsen from Hvidovre Hospital, University of Copenhagen, voiced his support for the study, saying: "We are very pleased to be continuing our work with Volition, especially on a study that is identifying patients who are going undiagnosed under the current screening system. This is an incredibly powerful longitudinal study because we are going to be collecting a huge amount of data over a seven-year period."
Jake Micallef, PhD, chief scientific officer at Volition said, "We are delighted to be working with the Hvidovre Hospital again. We believe that this is one of the biggest clinical studies ever undertaken. Each sample collected will be sufficient for multiple Nu.Q tests and the study will form the basis for our product pipeline in multiple cancers for many years to come."
Dr. Jason Terrell, Volition's chief medical officer and head of US operations, commented: "The study with Hvidovre Hospital can play a major role in the expansion of our clinical development program. Large prospective studies of this quality provide invaluable clinical information. The partnership with Hvidovre Hospital will support our mission to deliver accurate and cost-effective early stage cancer diagnostics."
Volition and Hvidovre Hospital expect to have initial interim results from this study by the end of 2018. Volition currently has numerous other ongoing studies on its Nu.Q blood tests, and its first test, the Nu.Q colorectal cancer triage test, is expected to have a commercial release in early 2017.
Volition is a life sciences company focused on developing diagnostic tests for cancer. The tests are based on the science of Nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.