NEW YORK (GenomeWeb News) – VolitionRx today announced an agreement with Hvidovre Hospital, part of the University of Copenhagen in Denmark, covering two clinical trials for colorectal cancer.
As part of the deal, VolitionRx said that it will use data from the trials to support its application for CE marking and a submission to the US Food and Drug Administration for a colorectal cancer test.
The trials will use VolitionRx's NuQ tests, based on the firm's Nucleosomics technology — which identifies and measures nucleosomes in the bloodstream — for the analysis of blood samples from about 10,800 patients. In a retrospective study, VolitionRx will analyze samples collected between 2010 and 2012 from some 4,800 patients with colorectal cancer, other malignancies, polyps or adenomas, and benign bowel diseases. All the patients have undergone a colonoscopy.
VolitionRx said that it will have full access to all national registries and databases for the trial, which is expected to start in June with a pilot study of 1,000 samples.
The company also will jointly sponsor with the University of Copenhagen a prospective 6,000-patient colorectal cancer screening population trial. Sample collection is slated to begin in April 2014, and VolitionRx expects to pay about $1.8 million toward the collection of those samples.
The blood samples have been or will be collected under the direction of Hans Jorgen Nielsen, professor of surgical oncology in the department of surgical gastroenterology at Hvidovre Hospital.
"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," Jake Micallef, CSO of VolitionRx, said in a statement.