The authors report on their first experiences with the UroVysion fluorescencein situ hybridization (FISH) kit developed for the detection of bladder cancer. This new non-invasive diagnostic application of the FISH technique in the field of urology was elaborated to replace cystoscopy. The special urine examination method detects genetic alterations of the urothelial cells found in the urine, using fluorescent directlabeled DNA probes binding to the peri-centromeric regions of chromosomes 3, 7 and 17 as well as on the 9p21 locus. We aimed to evaluate the utility of UroVysion test in the light of the histological diagnosis. Urine samples from 43 bladder cancer patients and 12 patients with no or benign alterations were studied using a new application of FISH technique: the UroVysion reagent kit. The obtained FISH results were compared with the histological findings of the transurethral surgical resection specimens. The study rated the specificity and sensitivity of the technique 100% and 87%, respectively. Therefore, the technique could well fit into the diagnostic process of bladder carcinomas. Statistical analyses showed significant correlation between tumor progression and the severity of the genetic alterations detected by this FISH technique. Furthermore, positive correlation was found between tumor grade and the proportion of tumor cells showing genetic abnormality. The noninvasiveness, the robustness of evaluation and the high specificity/sensitivity are all in favor of this technique. The disadvantages are the higher costs of the technical background and the required future clinical studies to determine whether this technique can replace cystoscopy.
Key words
bladder cancer cystoscopy fluorescence in situ hybridization molecular pathology
Abbreviations
BTA test
Bard’s bladder tumor antigen test
CCD
charge-coupled device
CDKN2A
cyclin-dependent kinase inhibitor 2A
CEP
chromosome enumeration probe
CT
computed tomography
DAPI
4′,6-diamidino-2-phenylindole
FDA
United States Food and Drug Administration
FISH
fluorescence in situ hybridization
K-W/DMC tests
Kruskal-Wallis / Dunn’s multiple comparison tests
LSI
locus-specific identifier
MRI
magnetic resonance imaging
MW test
Mann-Whitney test
NMP22
nuclear matrix protein 22
PBS
phosphate-buffered saline
PCR
polymerase chain reaction
SSC
sodium chloride and sodium citrate solution
TPA
tissue polypeptide antigen
UroVysion test-positive cells
cells showing cytogenetic abnormalities listed in positivity criteria of UroVysion Bladder Cancer Recurrence Kit