A Menarini Diagnostics and Nucleix have announced a long-term commercial agreement for the exclusive distribution of the Bladder EpiCheck test in Europe. Under the new agreement, Menarini will assume exclusive marketing of the non-invasive Bladder EpiCheck test in Europe in the months ahead, aiming to accelerate its adoption.
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) tumour 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.
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 optimising 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."