Digitized microscopy in the diagnosis of bladder cancer

Abstract

BACKGROUND:Fluorescent in situ hybridization (FISH) analysis of urine samples has proven to be a valuable adjunctive test to urine cytology for both diagnosis and monitoring recurrence of urothelial carcinoma. Automated FISH analysis has the potential to improve laboratory efficiency and to reduce interobserver and intraobserver variability, resulting in more accurate, reproducible, assay performance.METHODS:A total of 3200 slides containing urine specimens, hybridized with the UroVysion Bladder Cancer Kit (Abbott Molecular, Des Plaines, Illinois), a 4‐probe set for chromosomes 3, 7, 17, and 9p21, was evaluated at Acupath Laboratories. The slides were analyzed over a 7‐month period, using the Ikoniscope ‐ oncoFISH bladder Test System (Ikonisys, New Haven, Connecticut).RESULTS:Analysis included the incorporation of a “flagging” system developed by Acupath Laboratories to identify cases, based on specific criteria, likely to benefit from further manual review. By using US Food and Drug Administration (FDA)‐cleared scoring criteria, 96.3% of the slides could be reported directly from the automated scan, requiring no manual review of the slide. For the remaining 3.7% of the samples (all of which were very hypocellular), a manual review of each slide subsequently allowed diagnoses to be successfully reported. The average scan time was 31.7 minutes, and the average slide scan review time was 8.3 minutes.CONCLUSIONS:This study demonstrated the value of an automated approach to the analysis of FISH slides, affording the benefit of high‐throughput while providing the user with the necessary images and tools to quickly and accurately report a case. Cancer (Cancer Cytopathol) 2011;. © 2011 American Cancer Society.

Role of Tetrasomy for the Diagnosis of Urothelial Carcinoma Using UroVysion Fluorescent In Situ Hybridization

“…4 In the urinary bladder, umbrella cells are often tetraploid. 5 Inflammation from a variety of sources, including a tumor with the subsequent release of growth factors, may induce tetraploidy. 6 On the other hand, tetraploidy may have a direct role in tumorigenesis, as an intermediate state in the development of aneuploid cancers.…”

Acu‐URO17 is a highly sensitive and specific bladder cancer biomarker

“…FISH for UroVysion TM was performed as described in previous literature. [14][15][16] In brief, voided urine specimens were collected and handled according to the guidelines established in the package insert provided with the UroVysion™ Bladder Cancer Kit. 17 Approximately 30-50 ml of voided urine was collected in a 120 ml bottle containing 33 ml of pre-aliquoted PreservCyt ™ Solution (Cytyc, Londonderry, NH).…”

“…Cells recovered from the voided urine specimens were individually added to a 12 mm circle imprinted on an Ikonisys slide (Ikonisys, Inc, New Haven, CT), using a 10 μl pipette. 14 Slides were processed using the VP-2000 Processor (Abbott Molecular, Inc., Des Plaines, IL) and followed the guidelines established by the UroVysion™ Bladder Cancer Kit. 17 The probe was then added to the slides and sealed using 12 mm coverslips and rubber cement.…”

“…Slides were then scanned with the Ikoniscope (Ikonisys, Inc, New Haven, CT), to identify any genetic abnormal cells. 14 The criteria for positive FISH abnormalities were established as follows: if the scan yielded ≥4 cells with an 'aneuploid' signal pattern, ≥12 cells with '0 gold', or ≥10 cells with a 'single gain' of one chromosomal locus, 15 or ≥10 cells with a 'tetraploid/near-tetraploid'. 16…”

“…FISH for UroVysion TM was performed as described in previous literature 14–16 . In brief, voided urine specimens were collected and handled according to the guidelines established in the package insert provided with the UroVysion™ Bladder Cancer Kit 17 .…”