A. Menarini Diagnostics has entered a long-term commercial partnership with Nucleix for the exclusive distribution of the latter’s Bladder EpiCheck test in Europe.

Bladder EpiCheck is a non-invasive, CE-marked diagnostic test that detects primary or recurrent bladder cancer and upper tract urinary cancer.

It 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 support cystoscopy.

The test is used in follow-up for non-muscle invasive bladder cancer (NMIBC) tumour recurrence to replace or postpone cystoscopy.

It is also included in the EAU Clinical Guidelines as an ancillary tool in the diagnosis and monitoring of UTUC.

Nucleix executive chairman and CEO Chris Hibberd said: “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.”

Nucleix is a liquid biopsy company that leverages NGS-based and PCR-based technology to identify methylation changes for the detection of early-stage and recurring cancer.

Its non-invasive cancer test, Bladder EpiCheck delivers highly accurate and sensitive results, while providing an easy testing option for physicians, patients, and the healthcare system.

Bladder EpiCheck could detect high-grade disease early and potentially reduce the frequency of cystoscopies, which may decrease the burden of bladder cancer surveillance.

A. Menarini Diagnostics said that its partnership with Nucleix would advance the adoption of Bladder EpiCheck, to benefit and transform bladder cancer care for European patients.

Menarini Diagnostics general manager and global head Fabio Piazzalunga 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.”