FDA Grants 501K Clearance to Bladder EpiCheck for Surveillance in NMIBC

The FDA has granted 510K clearance to Bladder EpiCheck® for use as a noninvasive method for surveillance of tumor recurrence in previously diagnosed patients with non–muscle invasive bladder cancer (NMIBC), in conjunction with cystoscopy.¹

Bladder EpiCheck is a highly sensitive and specific test designed to analyze disease-specific changes across 15 DNA methylation markers linked with bladder cancer, and it is meant to be used in conjunction with standard-of-care (SOC) methods. This is the first methylation-based urine test performed on a quantitative polymerase chain reaction (qPCR) platform to receive clearance from the FDA. The test is also commercially available in Europe.

“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 SOC,” Aharona Shuali, MD, vice president of Medical Affairs at Nucleix, stated in a news release.

In a single-center, prospective study performed at Catholic University of the Sacred Heart in Rome, Italy, Bladder EpiCheck demonstrated high diagnostic values compared with urine cytology.²

The primary end point of the study was the sensitivity and specificity of Bladder EpiCheck to detect any type of bladder cancer recurrence. The specificity and sensitivity of the test in patients with high-risk recurrence and in those recently treated with endovesical therapy served as secondary end points.

In follow-up for 231 patients with NMIBC, the negative predictive value for Bladder EpiCheck was 89% compared with 83% for cytology. Moreover, the positive predictive value for Bladder EpiCheck and cytology was 73% and 67%, respectively.

Specifically, in patients with high-grade NMIBC, Bladder EpiCheck displayed a sensitivity of 91% compared with 81% for cytology. In this group, the specificity of Bladder EpiCheck was 85% vs 83% for cytology. The negative predictive values were 96% and 92% for Bladder EpiCheck and cytology, respectively.

In patients who received ongoing or recent endovesical treatment, Bladder EpiCheck produced a sensitivity of 88% compared with 73% for cytology. In this patient population, Bladder EpiCheck had a specificity of 97% vs 85% for cytology. The negative predictive values for Bladder EpiCheck and cytology were 92% and 82%, respectively.

Study authors concluded that Bladder EpiCheck could improve the management of patients with bladder cancer by reducing the number of inconclusive or suspicious cytology and endoscopy reports, and by decreasing the number of further examinations.

“We are pleased with the FDA’s decision to grant Bladder EpiCheck 510K clearance, allowing the test to be commercialized in the United States,” Eli Frydman, PhD, president at Nucleix, added in a news release.¹ “With this clearance, we look forward to offering physicians and their patients in the United States access to our reliable, objective and noninvasive 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 noninvasive diagnostic tools to enhance patient care.”

References

1. Nucleix’s Bladder EpiCheck® receives FDA 510(k) clearance for monitoring of non-muscle invasive bladder cancer (NMIBC) recurrence. News release. May 4, 2023. Accessed May 5, 2023. https://www.businesswire.com/news/home/
2. Ragonese M, Di Gianfrancesco L, Palermo G, et al. The role of Bladder Epicheck test in follow-up of patients with non-muscle invasive bladder cancer. Clin Genitourin Cancer. 2022;20(4):e271-e275. doi:10.1016/j.clgc.2022.03.009