title: A novel urine cytology stain for the detection and monitoring of bladder cancer.
abstract: OBJECTIVE
  CellDetect® 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.
  
  
  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.
authors.affiliation: Zetiq Technologies Ltd., Tel Aviv, Israel. Electronic address: noa@m-medic.com.
authors.forename: Noa
authors.initials: N
authors.lastname: Davis
authors.affiliation: Department of Urology, Chaim Sheba Medical Center, Ramat-Gan, Israel.
authors.forename: Yoram
authors.initials: Y
authors.lastname: Mor
authors.affiliation: Zetiq Technologies Ltd., Tel Aviv, Israel.
authors.forename: Pavel
authors.initials: P
authors.lastname: Idelevich
authors.affiliation: Zetiq Technologies Ltd., Tel Aviv, Israel.
authors.forename: Dov
authors.initials: D
authors.lastname: Terkieltaub
authors.affiliation: Zetiq Technologies Ltd., Tel Aviv, Israel.
authors.forename: Vivi
authors.initials: V
authors.lastname: Ziv
authors.affiliation: Zetiq Technologies Ltd., Tel Aviv, Israel.
authors.forename: Adi
authors.initials: A
authors.lastname: Elkeles
authors.affiliation: Patho-Lab Diagnostics Ltd., Ness Ziona, Israel.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Lew
authors.affiliation: LEM Pathology Laboratory, Ness Ziona, Israel.
authors.forename: Elimelech
authors.initials: E
authors.lastname: Okon
authors.affiliation: Department of Urology, Chaim Sheba Medical Center, Ramat-Gan, Israel.
authors.forename: Menachem
authors.initials: M
authors.lastname: Laufer
authors.affiliation: Department of Urology, Chaim Sheba Medical Center, Ramat-Gan, Israel.
authors.forename: Jacob
authors.initials: J
authors.lastname: Ramon
authors.affiliation: Institute of Urology, Rabin Medical Center, Petach-Tikva, Israel.
authors.forename: Daniel
authors.initials: D
authors.lastname: Kedar
authors.affiliation: Institute of Urology, Rabin Medical Center, Petach-Tikva, Israel.
authors.forename: Jack
authors.initials: J
authors.lastname: Baniel
authors.affiliation: Institute of Urology, Rabin Medical Center, Petach-Tikva, Israel.
authors.forename: Ofer
authors.initials: O
authors.lastname: Yossepowitch
mesh_terms: D006801:Humans; D013194:Staining and Labeling; D001749:Urinary Bladder Neoplasms / Q000473:pathology*; D014556:Urine / Q000166:cytology*
keywords: carcinoma; diagnostic tests and procedures; staining and labeling; urinary bladder; urothelium