A Novel Urine Cytology Stain for the Detection and Monitoring of Bladder Cancer

Purpose: CellDetect (R) is a unique platform technology comprising a proprietary plant extract and 3 dyes that enables color discrimination between malignant (red) and benign (green) cells based on specific metabolic alterations exclusive to the former. Preclinical studies and clinical trials demonstrated the applicability of the new technology in many cell culture lines and various cancers. We explored its performance characteristics in bladder cancer. Materials and Methods: We performed an open label, 2-step study at tertiary medical centers. The study enrolled patients with newly diagnosed or a history of urothelial carcinoma. Step 1 involved staining archived biopsies. Slides were evaluated by 2 independent pathologists, who determined the concordance of the new staining technology with the hematoxylin and eosin based diagnosis. Step 2 included staining urine specimens with the new method and comparing findings to the patient final diagnosis and the results of standard urine cytology. Results: A total of 58 archived biopsies were collected. The concordance of staining using the new platform technology with the hematoxylin and eosin based diagnosis was 100%. The new method applied to 44 urine smears showed 94% sensitivity and 89% specificity to detect urothelial carcinoma. Compared to standard urine cytology the new technology had overall superior sensitivity (94% vs 46%), particularly for low grade tumors (88% vs 17%, each p <0.005). There was no significant difference in specificity between the 2 staining techniques. Conclusions: Findings show the capability of CellDetect to accurately identify urothelial carcinoma. This indicates that the technology can be further developed to provide an alternative urine cytology test with diagnostic value that may have significant clinical benefits.