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).
FLORENCE, Italy, Sept. 9, 2024 /PRNewswire/ -- 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.
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 cancer[1] as there are
approximately 760,000 people in Europe living with the disease[2].
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].
Contact: PAVY Consulting, Linda
PAVY, lipavy@pavyconsulting.com
Logo -
https://mma.prnewswire.com/media/2499333/Menarini_Diagnostics_and_Nucleix_Logo.jpg
View original
content:https://www.prnewswire.co.uk/news-releases/a-menarini-diagnostics-and-nucleix-announce-a-strategic-partnership-for-a-non-invasive-bladder-cancer-test-in-europe-302241244.html