NAMUR, Belgium, Jan. 28, 2016 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX), today announced that the Company's subsidiary, Belgian Volition SA, has received the International Standards Organization (ISO) certification EN ISO 13485:2012 for its quality management system for the design, development, production and distribution of its NuQ® blood tests for a broad range of cancers.
EN ISO 13485:2012 certification relates to quality management systems in the field of medical devices, including in vitro diagnostic (IVD) devices. The EN prefix denotes that the certification is aligned with the three EU Medical Devices Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices). VolitionRx's EN ISO 13485:2012 certificate was awarded by one of the world's leading certification bodies for the ISO, TUV-SUD, headquartered in Munich, Germany.
Dr. Gaetan Michel, Chief Executive Officer of Belgian Volition SA, stated, "ISO certification is a significant accomplishment and a key milestone for VolitionRx, demonstrating that the Company meets international regulatory standards and strict requirements for risk management and effective processes to design, manufacture and distribute our NuQ® blood tests. This certification allows VolitionRx to continue our focused efforts for the commercialization of NuQ® cancer tests in Europe and other major markets worldwide."
Cameron Reynolds, President and Chief Executive Officer of VolitionRx, said, "ISO certification affirms that our quality management system meets the highest standards and exemplifies VolitionRx's commitment to product quality. We anticipate bringing to market our first NuQ® blood-based cancer test, for clinical use in Europe this year and in the U.S. in 2017. Our goal is to enable accurate and affordable detection of early-stage cancer and to improve patient outcomes. I would like to congratulate the entire Belgian Volition team for the enormous amount of effort they have put into achieving this key organizational milestone."
VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. 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 U.S. and ultimately, worldwide.
Anita Heward, VolitionRx
Telephone: +44 (0) 7756 034243
Kirsten Thomas, The Ruth Group
Telephone: +1 (508) 280-6592
Scott Powell, VolitionRx
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," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of the Company's bodily-fluid-based diagnostic tests as well as the Company's ability to develop and successfully commercialize such test platforms 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 Reports 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.
Nucleosomics®, NuQ® and HyperGenomics® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners.
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SOURCE VolitionRx Ltd