In the letter, Mr. Reynolds outlines several significant accomplishments to date and highlights the fact that the company believes that it is close to achieving a key clinical milestone with the completion of a 680-subject trial for the Nu.Q Frontline Asymptomatic Colorectal Cancer Screening Test.
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| [03-January-2018] |
| ISNES, Belgium, Jan. 3, 2018 /PRNewswire/ -- VolitionRX (NYSE AMERICAN: VNRX) (“Volition”) today released an important letter from Group CEO, Cameron Reynolds updating the company’s shareholders. In the letter, Mr. Reynolds outlines several significant accomplishments to date and highlights the fact that the company believes that it is close to achieving a key clinical milestone with the completion of a 680-subject trial for the Nu.QTM Frontline Asymptomatic Colorectal Cancer Screening Test. Volition expects to report the results from this study in early February. “We believe that this will be our most important data release to date, given the fact that this product is for the large frontline screening market, and that it will show the accuracy of our test in a sizable cohort with a large number of assays tested” stated Mr. Reynolds. “The study, conducted in collaboration with the Hvidovre Hospital of the University of Copenhagen, included 680 asymptomatic colorectal cancer screening subjects (including 100 cancers), and tested up to 30 assays including the largest number of Nu.Q markers tested to date, and some established orthogonal markers. From this study, a small number of markers will be taken into Volition’s very large European trials this year and the company expects that this will give it a strong indication for one or more U.S. products. This study has given us the confidence to start the next stage with a study of some 4,300 subjects, the results of which we hope to complete by March 31, 2018. We then plan to complete a large blinded 10,000+ subject study in the second quarter of 2018 to ensure that we have the data in multiple trials to back up our product claims this year. We also expect to get a CE Mark in parallel so that the Nu.Q Frontline Asymptomatic Colorectal Cancer Screening Test will be registered for sale in the 28 European Union member states by September 30, 2018. We believe that this represents a very large commercial opportunity for Volition with a total addressable market of approximately 150 million people of screen relevant age.” continued Mr. Reynolds. “We are also delighted to announce the completion of the Triage Pathway Design Study in Denmark with the report anticipated by the end of January. In addition to the letter to shareholders (full version available https://content.equisolve.net/volitionrx/media/294247c3763853e9265e6795bbaa62e5.pdf ), Volition also released a video detailing its achievements of 2017 and its plans for 2018, this is available to view at https://ir.volitionrx.com/a-look-back-at-2017 Volition kicks off 2018 hosting a range of meetings at Healthcare week in San Francisco, California from January 8 through January 12, 2018. Should you wish to meet with the management team please contact Louise Day, Volition’s Chief Marketing and Communications Officer, at L.day@volitionrx.com. About Volition Volition is a multi-national life sciences company developing simple, easy to use blood-based cancer tests to accurately diagnose a range of cancers. The tests are based on the science of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present. As cancer screening programs become more widespread, Volition’s products aim to help to diagnose a range of cancers quickly, simply, accurately and cost effectively. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life. Volition’s research and development activities are currently centered in Belgium, with additional offices in London, Texas and Singapore, as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide. For more information about Volition, visit Volition’s website (http://www.volitionrx.com) or connect with us via: Twitter: https://twitter.com/volitionrx The contents found at Volition’s website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document. The addresses for Volition’s website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only. Media / Investor Contacts Louise Day, Volition Scott Powell, Volition L.day@volitionrx.com S.powell@volitionrx.com +44 (0)7557 774620 +1 (646) 650 1351 ------------------ ----------------- Joseph Green, Edison Advisors Rachel Carroll, Edison Advisors jgreen@edisongroup.com rcarroll@edisongroup.com +1 (646) 653 7030 +44 (0)20 3077 5711 ----------------- ------------------- 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,” “hopes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “may,” “will” and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of Volition’s bodily-fluid-based diagnostic tests as well as Volition’s ability to develop and successfully commercialize such test platforms for early detection of cancer. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition’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 Volition’s development pipeline or any other diagnostic products Volition might develop; Volition will face fierce competition and Volition’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 Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition’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, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances. Nucleosomics®, NuQ®, Nu.QTM 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. Additionally, unless otherwise specified, all references to "$" refer to the legal currency of the United States of America. View original content:http://www.prnewswire.com/news-releases/volitionrx-limited-releases-letter-to-shareholders-including-status-update-on-key-clinical-milestone-300576953.html SOURCE VolitionRx Limited | ||
Company Codes: AMEX:VNRX |
