Nucleix Receives FDA 510(k) Clearance of Bladder EpiCheck® for Monitoring of NMIBC Recurrence

Nucleix has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Bladder EpiCheck® for use as a non-invasive method for surveillance of tumor recurrence in patients previously diagnosed with non-muscle invasive bladder cancer (NMIBC), in conjunction with cystoscopy.

Bladder EpiCheck is a highly sensitive and specific test that analyzes subtle disease-specific changes across 15 methylation markers that are associated with bladder cancer. The test is commercially available in Europe and is the first of its kind methylation-based urine test performed on a qPCR platform to be cleared by the FDA.

In the United States, bladder cancer is the sixth most common cancer.1 There are approximately 700,000 people affected by bladder cancer living in the United States, with the vast majority of them categorized as NMIBC patients.1,2 In addition, more than 80,000 new cases of bladder cancer are detected annually.2 While NMIBC can be treated with both surgical and therapeutic methods, it is characterized by a very high rate of recurrence (up to 70% over a five-year period).2 As a result, it requires frequent surveillance in order to promptly detect high-grade recurrence and treat it before it progresses and becomes life threatening. The standard of care involves frequent and invasive cystoscopies that patients endure up to four times a year for at least five years and, in some cases, for the remainder of their life.

“Because surveillance of NMIBC remains one of the most invasive and lengthy processes to manage for patients across the oncology landscape, an objective, sensitive and specific urine-based test like Bladder EpiCheck is an important new tool that physicians can leverage, in conjunction with the current standard of care,” said Aharona Shuali, M.D., Vice President of Medical Affairs at Nucleix.

“We are pleased with the FDA’s decision to grant Bladder EpiCheck 510(k) clearance, allowing the test to be commercialized in the United States,” said Eli Frydman, Ph.D., President at Nucleix. “With this clearance, we look forward to offering physicians and their patients in the United States access to our reliable, objective and non-invasive bladder cancer test that can be performed at any licensed central or local labs, thus providing healthcare professionals the flexibility to run the test where it is needed. This clearance further validates Nucleix’s EpiCheck-based technology and our ability to provide physicians non-invasive diagnostic tools to enhance patient care.”

Nucleix is evaluating strategic partnerships and other market access activities for the commercial launch of Bladder EpiCheck in the United States.