The agreement includes CE Mark performance evaluation and doubles the Hospital’s prospective trial of 20 cancers, adding a range of additional vital background work
VolitionRx Limited, a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, has announced that VolitionRx has extended its agreement with University Hospital Bonn, Germany, pursuant to which University Hospital Bonn will externally conduct the performance evaluation for CE marking of VolitionRx’s proprietary NuQ assays as a tool for detecting colorectal cancer.
Additionally, as part of the agreement, the Hospital has doubled the size of its prospective study from 2,000 to 4,000 patients and agreed to a range of other work including launching a 100-patient lung cancer-specific prognostic monitoring trial.
The CE mark performance evaluation will be led by Priv-Doz. Dr. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn. His team will use VolitionRx’s NuQ kits as a confirmatory trial on patient samples from VolitionRx’s ongoing collaboration with Hvidovre Hospital, Denmark, for CE regulatory purposes.
Dr. Holdenrieder is also leading the expanded German prospective study, which is designed to evaluate the performance of VolitionRx’s assays across patients with the 20 most prevalent cancer types and matched healthy individuals and those with competing conditions.
Dr. Holdenrieder commented, “VolitionRx has seen some impressive results in recent months, with significant differentiation shown. If the data continues to impress, we believe this technology could have great potential and we want to be at the heart of this research. With that said, we decided to expand our prospective trial and agreed to run the performance evaluation for colorectal cancer. We hope our research further confirms the accuracy of these tests and allows their clinical use in Europe.”
Cameron Reynolds, CEO of VolitionRx, added, “We’d like to thank Dr. Stefan Holdenrieder’s team for their continued support, and we are excited to expand our collaboration. University Hospital Bonn’s performance evaluation will be crucial to our CE mark application process, which we aim to complete in 2014. Also, the doubling of their prospective multi-cancer trial will give us a very good indication of the nucleosome structures in a very wide range of cancers.”
As part of the expanded collaboration, University Hospital Bonn will also perform a wide range of beta testing and pre analytics that are key to further refining the Nucleosomics technology.
VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. The tests are based on the science of Nucleosomics which is the practice of identifying and measuring nucleosomes in the bloodstream – an indication that cancer is present. The company's goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx’s research and development activities are currently centred in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the US and ultimately, worldwide.
25 April 2014