VolitionRx Extends Agreement with University Hospital Bonn to Include CE Mark Performance Evaluation
News Apr 24, 2014
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.