A. Menarini Diagnostics and liquid biopsy firm Nucleix have signed a strategic partnership for the exclusive distribution of Nucleix's Bladder EpiCheck test for detecting and monitoring the recurrence of bladder cancer and upper tract urothelial carcinoma (UTUC).
The agreement was announced at the 36th European Congress of Pathology, which is being held in Florence, Italy, from September 7 to September 11.
Under the terms of the agreement, A. Menarini Diagnostics will have the exclusive rights to distribute the noninvasive urine Bladder EpiCheck test in the European Union (EU). Financial and other terms of the agreement were not disclosed.
"With this agreement, we are expanding our portfolio by providing patients in Europe a noninvasive alternative for detecting primary and recurrent bladder cancer through a simple urine test," Fabio Piazzalunga, general manager and global head of A. Menarini Diagnostics, said in a statement.
The firms noted that the CE-marked test, which detects DNA methylation patterns in urine that are linked to urothelial cancer, has been included in the European Association of Urology clinical guidelines as a urine test that may be used in the initial diagnostic workup of bladder cancer to determine if the use of cystoscopy is appropriate and in follow-up to monitor for nonmuscle-invasive bladder cancer tumor recurrence to replace or postpone cystoscopy.
In 2022, the EU label for the EpiCheck test was expanded to include aiding in the detection of primary bladder cancer and UTUC in patients with hematuria, other urinary tract symptoms, or findings indicative of malignancy.
