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.
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
LinkedIn: https://www.linkedin.com/company/volitionrx
Facebook: https://www.facebook.com/VolitionRx/
YouTube: https://www.youtube.com/user/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
L.day@volitionrx.com
+44 (0)7557
774620
|
Scott Powell,
Volition
S.powell@volitionrx.com
+1 (646) 650
1351
|
Tirth Patel,
Edison Advisors
tpatel@edisongroup.com
+1 (646) 653
7035
|
Rachel Carroll,
Edison Advisors
rcarroll@edisongroup.com
+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," "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.
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SOURCE VolitionRx Ltd