Today before the opening bell, VolitionRx Limited, a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, announced it has commenced blood sample analysis for its largest clinical study to date, in collaboration with Hvidovre Hospital, Denmark. Samples collected in 2010-2012 from approximately 4,800 patients are being entered into a blind retrospective study to further establish the accuracy of VolitionRx's proprietary NuQ® assays as an initial screening tool for detecting colorectal cancer.
A previous smaller study in collaboration with CHU Dinant Godinne and UCL Namur Hospital in Belgium used two of VolitionRx's proprietary NuQ assays to test blood samples. The researchers achieved 85% detection rates for colorectal cancer and more than 50% of precancerous polyps. This latest clinical study will assess these and other assays in hopes of achieving a similar substantial detection rate with a higher patient population number. VolitionRx also completed a small pilot study on samples taken from a cohort of 40 rectal cancer patients at Hvidovre Hospital, achieving similar detection rates to those achieved in the CHU Dinant Godinne study.
Dr. Jake Micallef, Chief Scientific Officer of VolitionRx, commented, "The sheer scale of this 4,800-patient clinical study is far greater than previous studies which have included less than 100 patients. We expect the results will provide us with further proof of NuQ's ability to accurately detect colorectal cancer."
According to the press release, all samples assessed in this study are from patients who have undergone a colonoscopy and have confirmed presence or absence of colorectal cancer, other malignancies, polyps or benign bowel diseases. Patient data points such as age, gender and lifestyle choices, as made available from Danish national records, are also included within the analysis to offer greater mapping of possible disease causation.
Professor Hans Jørgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, stated, "We greatly anticipate the results from this extensive study particularly as past studies have provided such promising and powerful results. If the findings match our expectations, these data would strongly support the potential of the Nucleosomics science and blood based diagnostics as a powerful aid to increasing the early detection of cancers."
"The results from this study could bring us one step closer to getting our NuQ assay to market," Cameron Reynolds, CEO of VolitionRx, added. "These are exciting times not only for our company, but for the public at large."
VolitionRx anticipates reporting initial results from this trial in the near future.
Collection is expected to begin in April for a second Danish trial, announced in 2013. Hvidovre Hospital is coordinating the collection of samples from approximately 11,000 individuals. Data from these trials will be used to apply for a CE mark for a colorectal cancer test, and will also be submitted to the FDA.
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