HENDERSON, Nev., Oct. 23,
2023 /PRNewswire/ -- VolitionRx Limited (NYSE
AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company,
has unveiled what it believes to be an entirely new cancer
detection method at ESMO 2023¹, the annual congress of the European
Society for Medical Oncology.
In early-stage cancer, it is difficult to detect cancer-derived
circulating tumor DNA (ctDNA) in the blood because it may comprise
only 0.01% of the DNA present among a background of 99.99% normal
DNA. Moreover, most of the cancer DNA has exactly the same sequence
as normal DNA.
As physical separation of tumor derived and healthy circulating
DNA has never before been achieved, current ctDNA detection methods
involve DNA extraction, sequencing of all (cancer and normal)
circulating DNA and analysis of the sequencing data using
sophisticated computer bioinformatics, to tell them apart.
Volition has developed a novel method for liquid biopsy
involving the first reported physical isolation of a class of
tumor-derived ctDNA fragments from blood. Cancer derived ctDNA
fragments are then extracted after removal of all normal background
DNA of the same sequence for detection with a simple, low cost PCR
test.
Dr. Jake Micallef, Chief
Scientific Officer at Volition, explains:
"Based on our 13 years of work on the chemistry of circulating
chromatin fragments, we have developed a transformational wet
chemistry pathway that identifies and physically isolates chromatin
fragments that we know are tumor-derived from background DNA of the
same sequence, using Chromatin Immunoprecipitation (ChIP), followed
by quantitative real-time PCR (qPCR) testing to establish whether
cancer is present. Removal of normal DNA obviates expensive and
time-consuming DNA sequencing and bioinformatics allowing for
rapid, cost-effective detection in a routine blood test."
Volition's proof of concept data, presented at ESMO 2023,
demonstrates the isolation of tumor derived ctDNA fragments from
plasma. Volition tested the new method in a first small clinical
experiment and detected a range of liquid and other cancers,
including at early stage I disease. For example, 74% of leukemias
were detected at 96% specificity and 77% of colorectal cancers were
detected at 92% specificity with 2-qPCR assays.
Dr. Micallef added: "These early assays were developed using a
leukemia model, but surprisingly also detected many other cancers
including detecting colorectal cancer in a blood test with an
accuracy approaching that of current Fecal
Immunochemical Tests (FIT). The results to date are exciting
and may pave the way for a whole new class of undiscovered
biomarkers, with hundreds or thousands of possible targets. We are
now developing a range of cancer-specific assays which we expect to
be more accurate and look forward to sharing our progress beginning
in Q1 2024."
Dr Michael Hubank, Professor of
Translational Genomics at the Institute of Cancer Research, and
Scientific Director of Clinical Genomics at The Royal Marsden NHS
Foundation Trust, said: "The novel CTCF-ChIP/qPCR method developed
by Volition shows great promise for the accurate, rapid, low-cost
detection of cancer. The test complements existing approaches and
has the potential to reach the high levels of sensitivity and
specificity required to detect early-stage disease. It may also be
suitable for automation, enabling application in hospital
laboratories. We look forward to working with Volition on further
research and development in this important and exciting
area."
Volition has organized a data insights webinar on Thursday
26th October at 10.30 AM
U.S. Eastern to provide more information about the new cancer
detection method. Click HERE to register. The event will be
recorded and available afterward on-demand.
Notes:
- 'A novel immunoprecipitation/PCR method for detection of plasma
cfDNA fragments selectively occupied by CTCF in cancer.' D Pamart
et al. ESMO 2023
- In 2020 there were 19.3 million new cancer cases diagnosed
worldwide – this is set to grow to 30.2 million by 2040. (Globocan
Today and Globocan Tomorrow)
- In 2020, just under 10 million deaths were cancer-related
(9.96m) which is also expected to
increase to 16.3 million by 2040. (Globocan Today and
Globocan Tomorrow)
About Volition
Volition is a multi-national epigenetics company powered by
Nu.Q®, its proprietary nucleosome quantification platform. Through
its subsidiaries, Volition is developing simple, easy to use, cost
effective blood tests to help diagnose and monitor a range of
life-altering diseases including some cancers and diseases
associated with NETosis such as sepsis and COVID-19. Early
diagnosis and monitoring have the potential to not only prolong the
life of patients but also improve their quality of life. 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.
Volition's research and development activities are centered in
Belgium, with an innovation
laboratory and office in the U.S. and additional offices in
London and Singapore.
For more information about Volition's Nu.Q® technology go to:
www.volition.com
The contents found at Volition's website address are not
incorporated by reference into this document and should not be
considered part of this document. This website address is included
in this document as an inactive textual reference only.
Media Enquiries:
Louise
Batchelor/Debra Daglish,
Volition, mediarelations@volition.com +44 (0)7557 774620
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, among other topics, Volition's estimated market
opportunity, the effectiveness of Volition's blood-based
diagnostic, prognostic and disease monitoring tests, and Volition's
ability to develop and successfully commercialize such test
platforms for early detection of cancer and other diseases as well
as serving as a diagnostic, prognostic or disease monitoring tools
for such diseases. Volition's actual results may differ materially
from those indicated in these forward-looking statements due to
numerous risks and uncertainties, including, without limitation,
results of studies testing the efficacy of its tests. For instance,
if Volition fails to develop and commercialize diagnostic,
prognostic or disease monitoring 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; a
failure by the marketplace to accept the products in Volition's
development pipeline or any other diagnostic, prognostic or disease
monitoring products Volition might develop; Volition's failure to
secure adequate intellectual property protection; Volition will
face fierce competition and Volition's intended products may become
obsolete due to the highly competitive nature of the diagnostics
and disease monitoring market and its rapid technological change;
downturns in domestic and foreign economies; 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™ and Nu.Q® 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 Limited