A noninvasive test for urinary biomarkers shows promise in ruling out high-grade upper tract urothelial carcinoma (UTUC) and may help more patients delay or avoid nephroureterectomy. The bladder EpiCheck® assay, produced by Israel’s Nucleix Ltd., detects a panel of epigenetic DNA methylation patterns found in urothelial cancer cells but not in healthy cells.

Alberto Breda, MD, chief of uro-oncology at Fundació Puigvert, Autonoma University of Barcelona in Barcelona, Spain, and colleagues presented their latest research findings on EpiCheck® during the AUA2021 Virtual Experience.

In a single-center prospective study (NCT04702347), Dr Breda and colleaegues enrolled 80 consecutive patients undergoing diagnostic or follow-up ureteroscopy at their institution, but had to exclude 2 of them because they had synchronous bladder cancer. Patients provided 20 mL urine samples from both the lower and upper tract that were tested using EpiCheck® and urine cytology.

Continue Reading

For high-grade UTUC in the upper tract, EpiCheck® displayed higher sensitivity (95.8% vs 64.0%) and negative predictive value (NPV; 97.2% vs 83.6%) compared with urinary cytology, the investigators reported. For UTUC of any grade in the upper tract, EpiCheck® also had higher sensitivity (84.8% vs 52.2%) and NPV (80.6% vs 60.0%) compared with cytology.

For high-grade UTUC in the lower tract, EpiCheck® showed higher sensitivity (73.7% vs 47.4%) and NPV (88.1% vs 82.7%) compared with cytology. For UTUC of any grade in the lower tract, EpiCheck® again showed higher sensitivity (58.5% vs 30.0%) and NPV (59.5% vs 51.7%) compared with cytology.

“There is a substantial unmet need in UTUC diagnosis and follow-up for the identification of patients with high-grade and invasive cancer,” Dr Breda stated in a press release. Both ureteroscopy and cytology have limitations, he noted.

“EpiCheck® appears to be a useful tool in the UTUC setting and it could find a crucial role in the diagnosis and follow-up of UTUC, particularly in detecting the absence of a high-grade disease. As EpiCheck® results are remarkable, this assay is now included in the diagnostic work-up of UTUC at our center.”


Gallioli A, Fontana M, Boissier R, et al. DNA methylation urine biomarkers test (EPICHECK® assay) in the diagnosis of upper tract urothelial carcinoma: results from a single-center prospective study. Presented at: AUA2021 Virtual Experience held September 10-13, 2021. Abstract PD43-05.

Nucleix presents two bladder EpiCheck® studies at EAU20 virtual congress, including interim data in patients with upper tract urothelial cancer [press release]. Businesswire; July 17, 2020.

Nucleix announces initial positive results in detection of upper tract urothelial carcinoma with its bladder EpiCheck urine test [press release]. Cision; January 23, 2019.