What does Mr. Hugh Mostafid think? 
A single-centre, retrospective study compared the performance of urine cytology with Bladder EpiCheck for detecting high-grade upper tract urothelial carcinoma (UTUC) in selective urine samples collected from the proximal tip of the ureter [1]. This study included 82 patients with clinically, localised UTUC and 52 patients with haematuria but no UTUC (disease prevalence: 61%).
The sensitivity and negative predictive value (NPV) for detecting high-grade UTUC was significantly higher with Bladder EpiCheck compared to cytology. Additionally, Bladder EpiCheck had a specificity and positive predictive value (PPV) of 100% in this cohort. The diagnostic accuracy of Bladder EpiCheck compared to urine cytology was 98% vs 73% [1].
Test performance for detecting high-grade UTUC in selective urine samples of a single-centre, retrospective study including 134 patients [1]
The authors concluded:
“Our data support the hypothesis that Bladder EpiCheck may represent a valid tool in the diagnostic process of patients with suspected UTUC.” [1]
These results were confirmed earlier this year by a single-centre, prospective trial which investigated the diagnostic accuracy of EpiCheck vs urine cytology in the clinical management of UTUC [2]. The disease prevalance, defined by histological confirmation of UTUC, was 57% in 86 patients eligible for ureteroscopy for suspicion of primary or recurrent UTUC. Bladder and selective urine samples were collected before ureteroscopy to perform cytology and Bladder EpiCheck test.
Test performance for detecting UTUC in selective urine samples (N=80) of a single-centre prospective study including 86 patients [2]
Also in urine samples collected from the bladder, the performance of Bladder EpiCheck was better compared to urine cytology.
Test performance for detecting UTUC in bladder urine samples (N=68) of a single-centre prospective study including 86 patients [2]
The authors of this study concluded:
“EpiCheck could potentially change the assessment and management of UTUC decreasing the number of unnecessary procedure, without compromising the diagnostic effectiveness.” [2]
In conclusion, 2 independent studies reported a higher sensitivity and NPV for detecting high-grade UTUC with Bladder EpiCheck compared to cytology. Both studies showed that Bladder EpiCheck has sufficient high-grade sensitivity and NPV in selective urine samples to rule out high-grade UTUC.
References
- Pierconti F, Martini M, Fiorentino V, et al. Hum Pathol 2021;118:42-8. PubMed
- Territo A, Gallioli A, Diana P, et al. J Urol 2022;208:570-9. PubMed