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 -- 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 36^th 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 

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