A. Menarini Diagnostics, a leader in in vitro diagnostics, has partnered with liquid biopsy company Nucleix in a strategic move to advance bladder cancer care across Europe. Announced at the 36th European Congress of Pathology in Florence, the two firms have entered into a long-term agreement for the exclusive distribution of Bladder EpiCheck®, a non-invasive test designed to detect bladder cancer and upper tract urinary cancer (UTUC).
The collaboration brings the promise of improved detection and monitoring of bladder cancer, with the potential to reduce reliance on invasive procedures. The Bladder EpiCheck® test, which has already received CE-mark approval, is now available for distribution across Europe under this agreement.
Bladder EpiCheck®: A Non-Invasive Solution
Bladder EpiCheck® is a urine-based test that can detect both primary and recurrent bladder cancer, as well as UTUC. It is included in the European Association of Urology (EAU) Clinical Guidelines as a possible alternative to cystoscopy, an invasive procedure commonly used in bladder cancer diagnostics and surveillance. The EAU guidelines suggest that the test may be used during the initial diagnostic workup to either supplement or potentially avoid cystoscopy. It is also recommended for follow-up monitoring in patients with non-muscle invasive bladder cancer (NMIBC), a form of the disease prone to frequent recurrence.
Bladder cancer remains the sixth most common cancer in Europe, with an estimated 760,000 people living with the condition. For patients diagnosed with NMIBC, regular and sometimes invasive monitoring is required to detect tumour recurrence and progression, which can lead to life-threatening conditions if left untreated.
Bladder EpiCheck® offers a non-invasive alternative to regular cystoscopies, which are uncomfortable and carry risks associated with invasive procedures. By using a simple urine test, patients and clinicians can monitor for signs of high-grade disease earlier, potentially reducing the number of cystoscopies required. This development could significantly alleviate the burden of bladder cancer surveillance, both for patients and healthcare systems.
Transforming Bladder Cancer Care
Chris Hibberd, Executive Chairman and CEO of Nucleix, expressed his optimism about the partnership with A. Menarini Diagnostics. He commented, “I am pleased to be working with A. Menarini Diagnostics to further build the Bladder EpiCheck® market in Europe. 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 optimising decision-making for the benefit of patients.”
The collaboration aims to accelerate the adoption of Bladder EpiCheck® across Europe, making it more accessible to patients in need of routine bladder cancer monitoring. Hibberd is hopeful that this test will support clinicians in better managing bladder cancer cases and personalising patient care, especially for those at high risk of disease recurrence.
Bladder cancer has long been a challenge for both patients and healthcare providers, particularly due to the high recurrence rate of NMIBC. For those at high risk, follow-up examinations can occur as frequently as every three months, requiring repeated cystoscopies. While essential for detecting recurrences, these invasive procedures are both costly and uncomfortable, creating a significant burden for patients and health systems alike.
Bladder EpiCheck® could be a game-changer in this regard, reducing the frequency of cystoscopies while still providing reliable and early detection of recurrent bladder cancer. This approach not only improves patient comfort but may also help reduce overall healthcare costs by decreasing the need for invasive procedures.
A Strategic Expansion for Menarini
For A. Menarini Diagnostics, the partnership with Nucleix represents a significant expansion of its diagnostic portfolio, particularly in the area of cancer detection. Fabio Piazzalunga, General Manager and Global Head of Menarini Diagnostics, said, “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. 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 company is well-established in the European diagnostic space and sees Bladder EpiCheck® as a valuable addition to its offerings. Menarini aims to leverage its extensive distribution network to bring the test to more healthcare providers across Europe, ultimately improving the standard of care for bladder cancer patients.
By focusing on non-invasive diagnostics, A. Menarini Diagnostics and Nucleix are not only transforming bladder cancer detection but are also addressing the broader challenge of making advanced healthcare solutions more accessible. The collaboration reflects a growing trend in healthcare towards less invasive, more patient-friendly approaches to disease management.
Looking to the Future
As bladder cancer remains a prevalent and potentially life-threatening condition in Europe, advancements in diagnostic technologies like Bladder EpiCheck® are crucial. The long-term agreement between A. Menarini Diagnostics and Nucleix is poised to accelerate the adoption of this innovative test across Europe, potentially improving outcomes for thousands of bladder cancer patients.
By reducing the need for frequent, invasive cystoscopies, Bladder EpiCheck® offers a new approach to cancer monitoring that could make a tangible difference in the lives of those affected by the disease. The collaboration between these two companies underscores the importance of partnerships in driving innovation in healthcare, particularly in areas where early detection and monitoring are critical to patient survival.
The alliance marks a significant step forward in bladder cancer care, with both companies expressing confidence that their joint efforts will benefit patients and clinicians alike. As this new chapter in cancer diagnostics unfolds, the hope is that Bladder EpiCheck® will become a widely accepted and trusted tool in the fight against one of Europe’s most common cancers.
