Study will assess VolitionRx’s proprietary Nucleosomics？ platform for non-invasive diagnosis of endometriosis
NAMUR, Belgium, November 11, 2014 /PRNewswire/ — VolitionRx Limited (OTCQB: VNRX), a life sciences company focused on developing blood-based diagnostic tests, today announced that it has entered an agreement with the University of Oxford, United Kingdom, to initiate a clinical study that will assess VolitionRx’s proprietary Nucleosomics® platform technology for the diagnosis of endometriosis through a simple blood test. Under the agreement, The University of Oxford will provide VolitionRx with serum and plasma samples from approximately 350 patients with endometriosis and 150 control patients over a period of two years. The samples are donated by participating women through the biospecimen repository of the Oxford Endometriosis CaRe Centre.
Endometriosis is a common and painful condition in which endometrial tissue, which normally lines the cavity of the uterus, grows in other parts of the body. It is a benign condition with a strong inflammatory component, which makes the disease a good candidate for Volition’s NuQ® assays. The condition mostly affects women during their reproductive life span, and is a leading cause of difficulty conceiving. Unfortunately, there are currently no clinically useful biomarkers available for this condition, meaning diagnosis is only possible by performing minimally invasive surgery (laparoscopy). Across the world, this typically results in a delay in diagnosis of nearly 7 years.
The prospective study will focus on the development of a simple blood test to help clinicians diagnose endometriosis at an earlier stage. The 350-patient sample collection, supplemented with approximately 150 retrospectively-collected samples, will comprise healthy and endometriosis-positive individuals confirmed by laparoscopy. Differences in circulating nucleosomes will be evaluated across the menstrual cycle using VolitionRx’s Nucleosomics® technology platform.
Collection of the samples will be led by Prof Christian Becker and Prof Krina Zondervan, of the Nuffield Department of Obstetrics & Gynaecology, University of Oxford, who are co-Directors of the Endometriosis CaRe Centre, Oxford. The Centre is a world leader in endometriosis research and clinical care and is dedicated to improve the life of women affected by the disease. The study will assess the samples collected from patients undergoing laparoscopic surgery for endometriosis-related symptoms or patients undergoing laparoscopic tubal sterilisation. Sample collection is anticipated to end in 2016 as part of an ongoing biospecimen collection and biobanking program.
“We are excited to sign this agreement with the University of Oxford,” commented Dr. Mark Eccleston, VolitionRx’s Collaborations Manager. “We look forward to assessing the potential of our test in the diagnosis of endometriosis and to build on our ongoing work in cancer screening by exploring applications of our NuQ® assays in diseases beyond cancer.”
Prof Becker said: “We are looking forward to the results of this study. It compliments our ongoing efforts in the Endometriosis CaRe Centre of identifying non-invasive biomarkers for endometriosis which will be an essential step towards improved patient care.”
In addition to this study, other clinical trials assessing the effectiveness of VolitionRx’s assays include:
- A 4,800 patient retrospective study and an 14,000 patient prospective study in colorectal cancer at Hvidovre Hospital, University of Copenhagen, Denmark
- A 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn, Germany
- A 250 patient study in colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium
- A study with MD Anderson, Texas, to establish the efficacy of VolitionRx’s NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form.
Office of Women’s Health. Endometriosis Fact Sheet. Available at: http://www.womenshealth.gov/publications/our-publications/fact-sheet/endometriosis.html
Nnoaham, K.E. et al. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011;96(2):366-373.
VolitionRx is a life sciences company focused on developing blood-based diagnostic tests. The tests are based on the science of Nucleosomics which is the practice of identifying and measuring nucleosomes in the bloodstream – an indication that cancer is present.
VolitionRx’s goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx’s research and development activities are currently centred in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the US and ultimately, worldwide.
Charlotte Reynolds, VolitionRx
Telephone: +44 (0) 795 217 7498
Kirsten Thomas, The Ruth Group
Telephone: +1 (646) 536-7014
Scott Powell, Investor Relations
Telephone: +1 (646) 650-1351
Lee Roth, The Ruth Group
Telephone: +1 (646) 536-7012
Safe Harbor Statement
Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests” and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of the Company’s blood-based diagnostic test as well as the Company’s ability to develop and successfully commercialize such test platform for early detection of cancer. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include the Company’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in the Company’s development pipeline or any other diagnostic products the Company might develop; the Company will face fierce competition and the Company’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, the Company does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.