FactsNewsProductsIkoniscope, an innovative technique for fluorescent in situ hybridization (FISH) in the diagnosis of urothelial carcinoma

April 23, 2024

Fluorescent in situ hybridization (FISH) of urinary specimens has been shown to be a valuable adjunctive test to urinary cytology for both diagnosis and monitoring of urothelial carcinoma recurrence. In a study published in the Wiley Online Library, 3200 slides containing urine specimens were analyzed and hybridized with the Uro Vysion Bladder Cancer kit (Abbott Molecular,Des Plaines, Illinois), a set of 4 probes that allow detection of chromosomes 3, 7, 17 and 9p21. The slides were analyzed over a 7-month period using the Ikoniscope – oncoFISH system (Ikonisys, New Haven, Connecticut).

Urinary cytology of specimens collected by spontaneous exfoliation and bladder cystoscopy are currently the standard methods by which patients are examined when they present with hematuria or cancer.

Urinary cytology has a high sensitivity and specificity to detect high-grade urothelial lesions (SHGUC) however, it may experience problems in detecting low-grade urothelial lesions (NHGUC), as opposed to bladder cystoscopy which however is considered an invasive, expensive and time-consuming technique. Because of these limitations, techniques using molecular biomarkers are often exploited as adjuvants in the diagnosis of urothelial carcinomas.
The Uro Vysion kit for bladder cancer, is a test for the detection of chromosomal aberrations in urine samples obtained by spontaneous exfoliation. The kit contains fluorescent in situ hybridization (FISH) DNA probes that highlight the centromeres of chromosomes 3,7,17 and 9p21; all associated with urothelial carcinoma.

Initially, UroVysion slides were evaluated under a microscope by an expert, however, limitations were found including: low throughput, high degree of fluorescence bleaching, and inability to return to a cell of interest by microscope.
The oncoFISH bladder Test System (Ikonisys, New Haven, Connecticut), is an FDA-approved System for automatically scanning slides containing cells from urinary specimens, fixed on a microscope slide and stained using the UroVysion kit.
The purpose of this article was to describe the performance characteristics of the oncoFISH bladder test.

In this study, patients were identified by the urologist, patients presenting with persistent hematuria or patients who were asked to perform the FISH Test as a follow-up of previous cytology results.
After cellulose slides were obtained and stained using the UroVysion kit, they were placed inside the appropriate Ikoniscope cassettes and scanned.
With this technique, each cell within the area of cell deposition is analyzed so that any abnormal cells can be determined more accurately.

All images and diagnostic information are archived.
The images were analyzed by a trained technician who pre-sorted the cells, which were then analyzed by a pathologist.
The quality of slide preparation, including cell abundance, FISH hybridization efficiency, slide cleanliness, and lid displacement have a major impact on the scanning performance of the Ikoniscope system.

FISH analysis of urine samples has proven to be a valuable adjunctive test to urinary cytology for the diagnosis and monitoring of urothelial carcinoma recurrence.
The ability of the Ikoniscope oncoFISH bladder testing system to scan slides quickly and accurately is a great asset to a laboratory.
The Ikoniscope oncoFISH bladder testing system software selects the most morphologically abnormal cells with the most FISH signals and produces bright, high-quality images. Cells are pre-classified into subclassifications in order of priority, so that the most abnormal cells are moved to the top of the review screen, facilitating the analytical process. Cells can be viewed individually, with other cells in the same field of view, in multiple focal planes, or as a composite image with all 4 FISH signals viewed individually or simultaneously.
The oncoFISH Ikoniscope bladder testing system identifies and visualizes cells at a rapid rate, averaging about 31.7 minutes per case and requiring an average review time of about 8.3 minutes per case, thus enabling high throughput.
This system allows slides to be scanned overnight so that cases are ready for review the next day.
In conclusion, this study demonstrates the value of an automated approach to slide analysis. The system used offered the advantage of high productivity by providing the user with the images and tools needed to report a case quickly and accurately. Such an approach has the potential to both improve laboratory efficiency and reduce inter-observer and intra-observer variability, resulting in more accurate and reproducible analysis performance.

Hospitex International, a leader in thin-layer cytology and cancer diagnostics, provides a solution based on a patented, state-of-the-art Nephelometric Smart Technology (NST) that enables an implementation in Ikonisys technology.

Ikonoscope’s FISH technology will enable the integration of Urine24, Hospitex’s consumer oncology diagnostics product, further improving its sensitivity, reliability, and efficiency and enabling further growth in the diagnosis of urothelial carcinoma.

Authors: William A. Marganski, PhD1; Vanessa El-Sirgany Costa, BS2; Michael W. Kilpatrick, PhD1;Triantafyllos Tafas, PhD1; Joon Yim, MD2; and Michael Matthews, MS2
Source: Cancer Cytopathology, Month 00, 2011

Congresso Triennale di Anatomia Patologica SIAPeC
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