Urine-based test demonstrates consistent efficacy in NMIBC surveillance


The Bladder EpiCheck test received FDA 510(k) clearance in May 2023 for use in patients with NMIBC.

The Bladder EpiCheck test demonstrated consistent positive performance in the surveillance of non–muscle-invasive bladder cancer (NMIBC) across all published peer-reviewed clinical studies on the test, according to findings from a literature review presented at the 2023 Society of Urologic Oncology (SUO) Annual Meeting in Washington DC.1

Neil Fleshner, MD, MPH, FRCSC

Neil Fleshner, MD, MPH, FRCSC

“As our molecular technology is improving, we are frankly there now where we can largely non-invasively monitor bladder cancer,” said Neil Fleshner, MD, MPH, FRCSC, who presented the findings from the study at the SUO meeting. Fleshner is a professor of urology at the University of Toronto, Canada.

Bladder EpiCheck, a polymerase chain reaction-based 15-marker methylation urine test, received FDA 510(k) clearance in May 2023 for use in patients with NMIBC.2 For the current study, investigators performed a literature review on July 6, 2023, after the test’s FDA clearance, assessing US and European pivotal studies as well as real-world studies on the tool.

Findings from the pivotal study conducted in the US3 showed an overall sensitivity of 67% with Bladder EpiCheck. Regarding high-grade sensitivity, the test demonstrated a sensitivity of 77% and a specificity of 84%. The positive predictive value (PPV) was 65% and the high-grade negative predictive value (NPV) was 95%. In total, the prospective, multicenter study included 449 patients.

Data from the prospective, multicenter European pivotal study4 included 353 patients and showed an overall sensitivity of 68% with the test. High grade-sensitivity was 89%, and high-grade specificity was 88%. The PPV was 45%, and high-grade NPV was 99%.

The investigators also identified 21 peer-reviewed articles on Bladder EpiCheck, of which 7 were unique clinical studies on NMIBC surveillance, made up of the European pivotal study and 6 independent studies. In a pooled analysis of the independent studies, overall sensitivity was 76%. Pooled high-grade sensitivity was 91%, and pooled specificity was 83%. The test also demonstrated a PPV of 50% and a high-grade NPV of 98% among the pooled data. In total, 1211 patients with NMIBC were assessed across all independent studies.

“All in all, it tells us that this test, now FDA approved, is ready for prime time in the sense that we need to now figure out how to incorporate it into our practices,” said Fleshner during the presentation. “This shows us that this era of non-invasive testing with urine to replace an invasive test is here.”

Upon assessment of all the data, the authors noted consistent and excellent results across all studies of Bladder EpiCheck included for analysis.

They concluded, “The high [high-grade] NPV supports the use of Bladder EpiCheck as a rule-out test for [high-grade] disease. With a high specificity and PPV, Bladder Epicheck’s false positive rates are low, potentially minimizing unnecessary downstream procedures and patient anxiety. These consistent results, across the pivotal and independent studies, demonstrate that Bladder EpiCheck performed either in a local or a central lab, could improve timely disease detection and compliance.”1


1. Fleshner N, Lotan Y, Grossman B, et al. Consistent performance of Bladder EpiCheck for NMIBC surveillance in the USA and European pivotal studies and in real world studies. Presented at: 2023 Society of Urologic Oncology Annual Meeting. November 28 – December 1, 2023; Washington, DC. Abstract 146

2. 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

3. Bladder EpiCheck 510(k) substantial equivalence determination decision summary. FDA.gov.

4. Witjes JA, Morote J, Cornel EB, et al. Performance of the Bladder EpiCheck™ Methylation Test for Patients Under Surveillance for Non-muscle-invasive Bladder Cancer: Results of a Multicenter, Prospective, Blinded Clinical Trial. Eur Urol Oncol. 2018;1(4):307-313. doi:10.1016/j.euo.2018.06.011

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