HENDERSON, Nev., Dec. 10,
2024 /PRNewswire/ -- VolitionRx
Limited (NYSE AMERICAN: VNRX) ("Volition"), a
multi-national epigenetics company, today announced
the results of a large-scale study which shows that its
Nu.Q® Cancer Test differentiated between malignant and benign
pulmonary nodules, found by Low Dose CT (LDCT) scan,
in patients suspected of lung cancer.
The 800-patient prospective study was led by Professor
Jin-Shing Chen and his team at
National Taiwan University Hospital.
Findings published in a paper that is currently undergoing peer
review and accessible on MedRXIV, conclude that a panel of two
Nu.Q® nucleosome quantification assays (H3.1 and H3K27Me3) showed a
diagnostic sensitivity of 92% and a Positive Predictive Value of
89% in identifying cancerous nodules when used in combination with
LDCT screening.
Professor Chen, Department Chief, Department of Surgery,
National Taiwan University Hospital, said:
"Lung cancer is a leading cause of cancer-related deaths
globally. LDCT is the gold standard for lung cancer screening and
has been instrumental in reducing mortality in high-risk patients.
However, it is highly sensitive and can result in a large number of
false positives and over-diagnosis, meaning patients with benign
nodules face unnecessary and invasive biopsy and surgery.
"Our findings suggest that the Nu.Q® Cancer blood test could
provide an accurate method for classifying and identifying
pulmonary nodules across different Lung-RADS categories, the
standard for lung cancer screening CT reporting and management
recommendations, including small nodules.
"Our team will now embark on a 500-patient, prospective
validation study, taking place in a real-world setting at the
National Taiwan University Hospital and National Taiwan University
Hospital Cancer Centre. The validation study is set to begin this
year and due for completion in 2025, potentially leading to the
inclusion of the Nu.Q® Cancer test in Taiwan's National Lung Cancer Screening
Program."
Jasmine Kway, Chief Executive
Officer of Singapore Volition, said:
"There is an unmet clinical need for accurate non-invasive tests
to differentiate between malignant and benign nodules in
combination with LDCT screening.
"The study conducted by the National Taiwan University Hospital
showed that our Nu.Q® biomarkers exhibited high sensitivity and
accuracy. These biomarkers demonstrated a high Positive Predictive
Value (PPV), which we believe can aid in the precise diagnosis of
lung cancer in patients.
"We believe our groundbreaking Nu.Q® Cancer test could support
physicians with clinical decision-making following LDCT. It could
enable them to identify the patients at highest risk and whose
nodules are more likely to be cancerous, while potentially
identifying patients who present with a low risk of lung cancer for
follow-up, to avoid unnecessary biopsy."
Volition is developing simple, easy-to-use, cost-effective blood
tests to help diagnose and monitor a range of life-altering
diseases in both humans and animals.
For more information about Volition's technology go to:
www.volition.com
About Volition
Volition is a multi-national company focused on advancing the
science of epigenetics. Volition is dedicated to saving lives and
improving outcomes for people and animals with life-altering
diseases through earlier detection, as well as disease and
treatment monitoring.
Through its subsidiaries, Volition is developing and
commercializing simple, easy to use, cost-effective blood tests to
help diagnose and monitor a range of diseases, including some
cancers and diseases associated with NETosis, such as sepsis. Early
diagnosis and monitoring have the potential not only to prolong the
life of patients, but also improve their quality of life.
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.
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. Such 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 expectations related to revenue
opportunities and growth, the timing, completion, success and
delivery of data from clinical studies, the timing of publications,
, the effectiveness and availability of Volition's blood-based
diagnostic, prognostic and disease monitoring tests, 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, and Volition's success in securing licensing
and/or distribution agreements with third parties for its products.
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,
including those 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 press 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™, Capture-PCR™ 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