ISNES, Belgium, Sept. 19, 2017 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced its colorectal cancer (CRC) strategy for Europe. As part of its strategy, Volition plans to select a frontline panel to be validated in two large trials (4,300 and 10,000 sample), followed by CE marking, with a goal to launch a European frontline CRC screening product in 2018.
Chief Executive Officer of Volition, Cameron Reynolds, commented, "We believe that the market for the frontline screening test represents the largest near-term opportunity for Volition, as there are 150 million Europeans of screening age. Our strategy for Europe is now in place using patient samples that have already been secured in our very large ongoing Danish trials. Our U.S. strategy includes a 13,500-patient study in collaboration with the Early Detection Research Network (EDRN) of the U.S. National Cancer Institute (NCI). We have also made significant progress in Asia. We look forward to executing on our worldwide strategies and to the anticipated launch of our frontline test in Europe in 2018."
"We are making significant progress with our frontline CRC screening test," said Dr. Gaetan Michel, Chief Executive Officer of Belgian Volition. Dr. Michel added, "We have received considerable support from the local government and agencies which has helped Volition's operations, notably through the large increase in capacity from our purpose-built facility which allows us to conduct more clinical trials effectively. This has also helped us grow our talented team and make key hires, which we will continue to do."
The current 12-month plan:
- Fourth Quarter, 2017 - Volition aims to complete its choice of a panel for the Nu.QTM colorectal cancer screening test for Europe.
- First Quarter, 2018 - The chosen panel will then be subject to validation in a 4,300-subject trial using secured samples from Danish cohorts, already acquired by Volition's subsidiary, Belgian Volition SPRL. Following the completion of the study, the results will be submitted for publication in a peer reviewed journal.
- Second Quarter, 2018 - The chosen panel will be subject to further validation in a blinded 10,000-subject trial using secured samples from Danish cohorts, then submitted for peer reviewed publication. This very large trial will include over 100 samples with colorectal cancer and will be representative of an asymptomatic screening population.
- Third Quarter, 2018 - CE Marking is expected to be completed on the chosen panel, providing the ability to market the product in 28 European Countries as a frontline colorectal cancer screening test. The completion of the CE Marking also offers a regulatory platform to expedite approval in many of the Asian markets.
Volition was recently informed by its Danish collaborators that the previously announced Triage Pathway Design Study is likely to be completed at the end of November 2017. Volition also expects that adaptions to the Nu.QTM Colorectal Cancer Triage Test will be completed around the same timeframe.
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.
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Media / Investor Contacts
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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.
SOURCE VolitionRx Ltd
Released September 19, 2017