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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