FDA grants 510(k) clearance to Bladder EpiCheck for NMIBC surveillance

The FDA has granted 510(k) clearance to Bladder Epicheck, a non-invasive method for detecting tumor recurrence in patients who were given a diagnosis of non–muscle-invasive bladder cancer (NMIBC).¹

"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,” says Aharona Shuali, MD.

According to Nucleix, the developer of the test, 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 methylation-based urine test is performed on a qPCR platform and is intended for use in conjunction with cystoscopy. Bladder Epicheck is commercially available in Europe, and it is the first of its kind to be cleared by the FDA in the United States, according to Nucleix.

“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, MD, in the news release. Shuali is the vice president of medical affairs at Nucleix.

Results on Bladder EpiCheck were presented at the 2022 Annual European Association of Urology Congress in Amsterdam, the Netherlands, where data were shared that showed the test to be a reliable predictor of NMIBC recurrence after BCG induction.² Data showed that 11 of 41 (27%) patients had a positive Bladder EpiCheck test result after BCG induction therapy, and these patients had a 3.2 times higher risk for tumor recurrence compared with patients who received a negative result.

Nucleix President Eli Frydman, PhD, added in the news release, “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 currently working on partnerships and market activities for commercial launch of the test in the US.

References

1. Nucleix’s Bladder EpiCheck receives FDA 510(k) cleareance for monitoring of non-muscle bladder cancer (NMIBC) recurrence. News release. Nucleix. May 4, 2023. Accessed May 5, 2023. https://www.businesswire.com/news/home/20230504006053/en/Nucleix%E2%80%99s-Bladder-EpiCheck%C2%AE-Receives-FDA-510-k-Clearance-for-Monitoring-of-Non-Muscle-Invasive-Bladder-Cancer-NMIBC-Recurrence

2. Mengual L, Ingelmo-Torres M, Carrasco R, et al. Utility of bladder EpiCheck methylation test for the surveillance of bladder cancer patients treated with bacillus Calmette-Guérin. Presented at 2022 Annual European Association of Urology Congress. Amsterdam, the Netherlands. July 1-4, 2022. Abstract A0077