The story has been corrected to say the EpiCheck test was cleared by the FDA in May 2023, not earlier this year.
NEW YORK — A. Menarini Diagnostics has signed an agreement for the exclusive European marketing rights to Nucleix's Bladder EpiCheck cancer recurrence test, the companies said on Monday.
The CE-marked test analyzes disease-specific changes in 15 DNA methylation markers in urine using qPCR to monitor tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Its European label was expanded in mid-2022 to include the detection of primary bladder cancer and upper tract urothelial carcinoma in patients presenting with hematuria, other urinary tract symptoms, or findings indicating malignancy.
Under the terms of the deal, Florence, Italy-based Menarini will become the exclusive marketer and distributor of Bladder EpiCheck in Europe. Financial and other terms were not disclosed.
The test was cleared by the US Food and Drug Administration in May 2023. Rehovot, Israel-based Nucleix maintains a CLIA- and CAP-accredited clinical laboratory in San Diego, which it established to support its commercialization efforts in the US.