A. Menarini Diagnostics and Nucleix Announce a Strategic Partnership for a Non-Invasive Bladder Cancer Test in Europe
September 09 2024 - 3:00AM
Business Wire
Under the commercial agreement, A. Menarini
Diagnostics will assume exclusive marketing of the non-invasive
Bladder EpiCheck® test in Europe in the months ahead, providing
patients and clinicians with a urine test to detect and monitor
recurrence of bladder cancer and upper tract urothelial carcinoma
(UTUC).
A. Menarini Diagnostics, a company bringing advanced solutions
to the in vitro diagnostic market, and Nucleix, a liquid biopsy
company revolutionizing cancer treatment by detecting the disease
earlier, announced at the 36th European Congress of Pathology in
Florence, that they have entered into a long-term commercial
agreement for the exclusive distribution of the Bladder EpiCheck®
test in Europe.
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This non-invasive CE-marked test detects primary or recurrent
bladder cancer and upper tract urinary cancer. Bladder EpiCheck is
included in the European Association of Urology (EAU) Clinical
Guidelines as a urine test that might be used in the initial
diagnostic workup of bladder cancer to avoid / implement cystoscopy
and in follow-up to monitor for non-muscle invasive bladder cancer
(NMIBC) tumor recurrence to replace or postpone cystoscopy. The
test is also included in the EAU Clinical Guidelines as an
ancillary tool in the diagnosis and monitoring of UTUC.
Bladder cancer is the sixth most common cancer1 as there are
approximately 760,000 people in Europe living with the disease2.
Surveillance is of paramount importance for NMIBC patients due to
the high rates of recurrence and risk of progression to
life-threatening disease. For high-risk NMIBC patients, follow up
can be as frequent as every three months and requires invasive
cystoscopies. By providing a non-invasive, monitoring test, Bladder
EpiCheck could detect high-grade disease early and potentially
reduce the frequency of cystoscopies, which may, in turn, decrease
the burden of bladder cancer surveillance for patients and health
systems alike while improving patient outcome by identifying the
patients who will benefit most from intervention.
“I am pleased to be working with A. Menarini Diagnostics to
further build the Bladder EpiCheck market in Europe,” commented
Chris Hibberd, Executive Chairman & CEO of Nucleix. “Given the
broad presence of A. Menarini Diagnostics, we believe they are the
right partner to expand the market footprint for our liquid biopsy
test that we believe will transform bladder cancer care by
supporting doctors in optimizing decision-making for the benefit of
patients.”
"With this agreement, we are expanding our portfolio by
providing patients in Europe a non-invasive alternative for
detecting primary and recurrent bladder cancer through a simple
urine test," said Fabio Piazzalunga, General Manager and Global
Head of Menarini Diagnostics. “This strategic agreement is a
significant testament to the company's position as a preferred
partner for promoting and bringing highly innovative diagnostic
solutions to market."
The alliance between A. Menarini Diagnostics and Nucleix aims to
accelerate the adoption of the Bladder EpiCheck® for the benefit of
European patients and transform bladder cancer patients' care.
About Nucleix®
Nucleix is a liquid biopsy company revolutionizing cancer
treatment with earlier disease detection at a time when
intervention can bring the greatest impact for patients. Leveraging
NGS-based and PCR-based technology to identify methylation changes,
the Company’s pioneering testing approach uses methylation-based
identification for early-stage and recurring cancer detection.
The Company’s non-invasive EpiCheck® delivers highly accurate
and sensitive results, all while providing a seamless testing
option for physicians, patients, and the healthcare system. The
Company is building an EpiCheck franchise, beginning with the
Bladder EpiCheck® kit, CE-marked and available in Europe for
primary and recurrent bladder cancer and upper tract urinary
cancer, and FDA 510(k) cleared for bladder cancer recurrence in the
United States.
The Company is advancing its Lung EpiCheck® test towards
commercialization for high-risk individuals, while evaluating
additional tests for other high-risk diseases. For more
information, please visit: https://www.nucleix.com.
About A. Menarini Diagnostics
A. Menarini Diagnostics brings advanced solutions to the In
Vitro Diagnostics (IVD) market and develops innovative systems and
reagents to provide healthcare professionals with reliable
information to meet their diagnostics needs. For more than 45
years, the Company has been dedicated to helping healthcare
professionals make safe and sustainable diagnoses, improving the
quality of life of people all over the world.
A. Menarini Diagnostics is part of the Menarini Group, a
multinational pharmaceutical, biotechnology and diagnostics company
headquartered in Florence, Italy, with more than 17,000 employees
in 140 countries.
For more information, please visit:
https://www.menarinidiagnostics.com/en-us/
1 Cancer TODAY | IARC - https://gco.iarc.who.int Data version:
Globocan 2022 (version 1.1) - 08.02.2024 2 Ferlay J, Ervik M, Lam
F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A,
Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer
Today. Lyon, France: International Agency for Research on Cancer.
Available from: https://gco.iarc.who.int/today, accessed [06 August
2024].
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