PURPOSE: CellDetect® is a unique platform technology which enables color discrimination between malignant (red) and benign (green) cells based on specific metabolic alterations exclusive to the former.
Pre-clinical studies and clinical trials have demonstrated applicability of CellDetect® in a plethora of cell culture lines and in various cancers. The purpose of the current study was to explore the performance characteristics of CellDetect® in bladder cancer.
MATERIALS AND METHODS: An open-label, two-step study conducted in tertiary medical centers enrolling patients with newly diagnosed or history of urothelial carcinoma (UC). The first step of the study involved staining of archived biopsy. Slides were evaluated by 2 independent pathologists and the concordance between CellDetect® and H&E-based diagnosis was determined. The second step included staining of urine specimens by CellDetect® and comparing the findings to the patients' final diagnosis and the results of standard urine cytology.
RESULTS: A total of 58 archived biopsies were collected. The concordance between the CellDetect® staining and H&E-based diagnosis was 100%. CellDetect® was applied to 44 urine smears demonstrating 94% sensitivity and 89% specificity in detecting UC. Compared to standard urine cytology, CellDetect® demonstrated overall superior sensitivity (94% versus 46%, respectively, P< 0.005), particularly in low grade tumors (88% versus 17%, P< 0.005). There was no significant difference in specificity between the 2 staining techniques.
CONCLUSION: The findings demonstrate the capability of CellDetect® in accurately identifying UC, indicating that this technology can be further developed to provide an alternative urine cytology test with diagnostic values that may have significant clinical benefits.
Written by:
Davis N, Mor Y, Idelevich P, Terkieltaub D, Ziv V, Elkeles A, Lew S, Okon E, Laufer M, Ramon J, Kedar D, Baniel J, Yossepowitch O. Are you the author?
Zetiq Technologies Ltd; Department of Urology, The Chaim Sheba Medical Center, Ramat-Gan, Israel; Patho-Lab Diagnostics Ltd, Ness Ziona, Israel; LEM Pathology Laboratory, Ness Ziona, Israel; Institute of Urology, Rabin Medical Center, Petach-Tikva, Israel.
Reference: J Urol. 2014 Jun 30. pii: S0022-5347(14)03917-2.
doi: 10.1016/j.juro.2014.06.079
PubMed Abstract
PMID: 24992334
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