By LabMedica International staff writers

Bladder EpiCheck is the first urine biomarker methylation test of its kind to be FDA cleared for NMIBC surveillance (Photo courtesy of Nucleix)

Bladder cancer ranks as the sixth most common cancer in the U.S., with around 700,000 individuals living with the disease and over 80,000 new cases detected each year. The majority of these cases are classified as non-muscle invasive bladder cancer (NMIBC). Although NMIBC can be treated surgically and therapeutically, it has a high recurrence rate (up to 70% over five years), necessitating frequent monitoring to detect high-grade recurrence and treat it promptly. The standard of care involves regular and invasive cystoscopies, which patients undergo up to four times annually for a minimum of five years or, in some cases, for their entire lives. Now, a simple, objective urine test for recurrent bladder cancer is set to become commercially available in the U.S. This test examines subtle disease-specific changes in DNA methylation markers with high sensitivity and specificity.

Nucleix (Rehovot, Israel) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Bladder EpiCheck as a non-invasive method for monitoring tumor recurrence in patients previously diagnosed with NMIBC, alongside cystoscopy. Bladder EpiCheck is a highly sensitive and specific test that analyzes subtle disease-specific changes in 15 methylation markers associated with bladder cancer. Already commercially available in Europe, Bladder EpiCheck is the first methylation-based urine test performed on a qPCR platform to be cleared by the FDA.

“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.”