Accuracy of an Oligonucleotide-Based Fluorescence In Situ Hybridization (FISH) Urine Assay: Prospective Study of 389 Patients Monitored for Recurrence of Bladder Cancer
David G Bostwick, Deloar Hossain. Bostwick Laboratories, Inc., Orlando, FL
Background: Current methods of fluorescence in situ hybridization (FISH) testing for bladder cancer in urine samples are slow and expensive, are BAC clone-based, and include one chromosome (loss of 9p21) that is rarely informative by itself. Oligonucleotide-based FISH probes have recently become available that have a shorter hybridization time (10 minutes vs. 16 hours), smaller probe size (25-35 nucleotides vs. 190kb), require less specialized equipment, and do not require sample cell density evaluation. However, these two FISH-based methods have not been previously compared.
Design: We prospectively enrolled 389 patients who had a prior history of bladder cancer and an ordered cystoscopy/biopsy for monitoring for recurrence. Each urine sample was tested by split-sample method for oligonucleotide-based FISH (aneuploidy for chromosomes 3, 6, 7, and 20), cytology, and UroVysionTM FISH (aneuploidy for chromosomes 3, 7, 17, and loss of 9p21), and the results were compared to cystoscopy/biopsy findings.
Results: Of the subjects included in the study, 336 gave informative results by oligonucleotide-based FISH, 352 by cytology, and 172 for UroVysionTM; overall hybridization efficiency for oligonucleotide-based FISH was 98.3%. Sensitivity and specificity was 52.9%, 21.2%, and 71%, and 84.7%, 93.4%, and 65.8% for oligonucleotide-based FISH, cytology, and UroVysionTM FISH, respectively. Results of cancer cases were similar for the two methods of FISH analysis (p=0.20).
Conclusions: Oligonucleotide-based FISH and UroVysionTM FISH appear to have similar predictive accuracy for monitoring recurrence of bladder cancer. However, the oligonucleotide-based method has multiple technical advantages.
Category: Genitourinary (including renal tumors)
Wednesday, March 6, 2013 9:30 AM
Poster Session V # 142, Wednesday Morning