This trial is being undertaken in addition to its four ongoing external clinical trials. The trial will be carried out in Volition’s laboratory on patient blood samples supplied by the Wales Cancer Bank (www.walescancerbank.com), which is based in Cardiff, in the United Kingdom.
Beginning late January, NuQ® tests will be conducted on blood samples taken from more than 800 cancer patients by the Wales Cancer Bank as well as healthy control volunteers. The expected sample distribution is as follows:
• Breast cancer: approx. 550 patients with a variety of subtypes, including invasive ductal carcinoma, invasive lobular and tubular carcinomas, and in-situ carcinoma ductal
• Colorectal cancer: approx. 230 patients with a variety of subtypes, at various stages from Stage A to Stage D
• Plus smaller numbers of patients with lung and pancreatic cancers.
The study follows a highly successful pilot study on 100 patient samples from the Wales Cancer Bank, (results of which were announced in December 2012), after which Volition was awarded scientific approval from the Bank for the number of patients needed for a full scale clinical trial.
Jake Micallef, Chief Scientific Officer of VolitionRx, says: “These larger studies follow successful completion of our own internal pilot studies. This is the next step in obtaining European market approval for Nucleosomics diagnostic tests (beginning with the patient numbers needed for breast and colorectal cancer), and establishing them in routine clinical use.”
Professor Malcolm Mason, Director of the Wales Cancer Biobank, says: “We are delighted to be providing patient blood samples for Volition’s cancer trial. Their technology shows promise and we were very happy with their initial results in the pilot study carried out in 2012. We look forward to seeing the results from this larger trial.”