Performance of CellDetect for detection of bladder cancer: Comparison with urine cytology and UroVysion

• Published in: Urologic oncology Vol. 41; no. 6; pp. 296.e1 - 296.e8
• Main Authors: Shefer, Hila Kreizman, Masarwe, Ismael, Bejar, Jacob, Naamnih, Luna Hijazi, Gueta-Milshtein, Keren, Shalata, Adel, Hadid, Yarin, Nativ, Omri, Nativ, Ofer
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2023
• Subjects: Carcinoma, Transitional Cell - diagnosis; Carcinoma, Transitional Cell - pathology; Cytology; Detection; Female; Humans; Male; Malignant bladder neoplasm; Prospective Studies; Sensitivity and Specificity; Urinary biomarkers; Urinary Bladder - pathology; Urinary Bladder Neoplasms - pathology; Urine; Detection; Urinary biomarkers; Malignant bladder neoplasm
• ISSN: 1078-1439; 1873-2496
• DOI: 10.1016/j.urolonc.2022.12.012

•CellDetect is a novel histochemical staining for detection of UC.•CellDetect shows high sensitivity and negative predictive value.•Further validation is warranted, particularly in patients with high grade tumors.•Compared to U-FISH and cytology, CellDetect had better detection rates. To compare the performance of CellDetect, a new biomarker with urine cytology and UroVysiontechnology for bladder cancer detection. We performed an IRB approved prospective, blinded single center study in patients on routine surveillance for nonmuscle invasive bladder cancer and those scheduled for transurethral resection of bladder tumor or radical cystectomy. Patients with bladder catheters, neobladder, ileal conduit, urinary stones, or those with upper tract carcinoma were excluded from the study. Voided urine sample was collected from the participants and each sample was divided into three equal aliquots (CellDetect, Urine cytology and Urovysion). Pathology of the operative specimen was considered the gold standard to which the three markers were compared. The study group included 93 patients with median age was 68 years (range: 34–92 years) with male to female ratio of 12:1. Pathologic evaluation revealed malignancy in 43 cases (46%) of whom 81% had previous history of urothelial bladder cancer. Among all studied markers CellDetect exhibited the best performance followed by urine cytology and U-FISH with diagnostic odds ratio of 4.33, 3.85, and 2.5 respectively. The overall sensitivity, specificity, negative predictive value, and positive predictive value for this test were 84%, 80%, 88%, and 74% respectively. The advantage of this new biomarker was observed both in high grade and low-grade cases. This study demonstrates the advantage of CellDetect as a urine-based assay to detect urothelial bladder cancer over urine cytology and U-FISH test. The high performance was maintained across all cancer grades and stages without compromising the assay specificity. Additional studies are required to test if it can be a noninvasive alternative to cystoscopy.