Evaluation of urovysion and cytology for bladder cancer detection

Dimashkieh, Haythem; Wolff, Daynna J.; Smith, T. Michael; Houser, Patricia M.; Nietert, Paul J.; Yang, Jack

doi:10.1002/cncy.21327

Cited by 133 publications

(57 citation statements)

References 43 publications

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“…Despite the stringency of test reporting as either positive or negative, difficulty of interpretation of chromosomal and morphologic changes does exist, potentially influencing the usefulness of the test in cancer detection. Limitations of previous publications on uFISH include varying definitions of what is considered a positive result, lack of histopathology and small sample size [14–19]. Also the likelihood a given bladder cancer may not have the chromosomal alterations measured by uFISH and thus not capable of being detected by the test is not entirely known.…”

Section: Introductionmentioning

confidence: 99%

A prospective comparison of UroVysion FISH and urine cytology in bladder cancer detection

et al. 2017

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BackgroundUroVysion fluorescence in situ hybridization (uFISH) was reported to have superior sensitivity to urine cytology. However uFISH studies are limited by varying definitions of what is considered a positive result, absence of histopathology and small sample size. The aim of our study was to better determine the performance characteristics of uFISH and urine cytology by overcoming some of the deficiencies of the current literature.MethodsIntraoperative bladder wash cytology and uFISH were collected prospectively on all patients. Strict definitions for positivity of uFISH and cytology were determined before initiating the study. A re-review of false-negative uFISH specimens was performed to analyze potential sources of error. Sixteen bladder tumors embedded in paraffin were analyzed by uFISH and compared with the result in the urine.ResultsOne hundred and twenty-nine specimens were analyzed. Sensitivity was 67% and 69% (p = 0.54); specificity was 72% and 76% (p = 1.0), for uFISH and cytology, respectively. Thirty-two false negative uFISH samples were re-reviewed. Low grade tumors often showed cells with abnormal morphology and patchy DAPI staining but diploid chromosomal counts and a few high grade tumors had tetraploid counts but less than needed to interpret uFISH as positive. uFISH study of the tumors revealed three categories; positive in both tumor and urine (9), negative in both tumor and urine (5) and positive in tumor but negative in urine (2).ConclusionIn a pathologically-confirmed analysis of bladder washed urine specimens, uFISH does not outperform urine cytology in cancer detection.

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Section: Introductionmentioning

confidence: 99%

A prospective comparison of UroVysion FISH and urine cytology in bladder cancer detection

et al. 2017

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“…This multiprobe FISH test was initially developed to improve the detection of invasive HGUC in voided urine and is now FDA-approved for initial diagnosis and surveillance of patients with hematuria [57]. The reported sensitivity and specificity of the test for detection of HGUC vary widely in the literature and have been reported from 8 to 100% and 29 to 100%, respectively [58]. This variability in the reported performance of the test may be due to lack of standardization of the technical testing procedure and test evaluation.…”

Section: The Use Of Ancillary Diagnostic Testing In Urine Cytologymentioning

confidence: 99%

The Paris System for Reporting Urinary Cytology: The Quest to Develop a Standardized Terminology

et al. 2016

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The main purpose of urine cytology is to detect high-grade urothelial carcinoma (HGUC). With this principle in mind, The Paris System (TPS) Working Group, composed of cytopathologists, surgical pathologists, and urologists, has proposed and published a standardized reporting system that includes specific diagnostic categories and cytomorphologic criteria for the reliable diagnosis of HGUC. This paper outlines the essential elements of TPS and the process that led to the formation and rationale of the reporting system. The Paris System Working Group, organized at the 2013 International Congress of Cytology, conceived a standardized platform on which to base cytologic interpretation of urine samples. The widespread dissemination of this approach to cytologic examination and reporting of urologic samples and the scheme's universal acceptance by pathologists and urologists is critical for its success. For urologists, understanding the diagnostic criteria, their clinical implications, and the limitations of TPS is essential if they are to utilize urine cytology and noninvasive ancillary tests in a thoughtful and practical manner. This is the first international/inclusive attempt at standardizing urinary cytology. The success of TPS will depend on the pathology and urology communities working collectively to improve this seminal paradigm shift, and optimize the impact on patient care.

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“…UroVysion is a FISH-based assay for detection of P16 tumor suppressor gene in chromosomes 3, 7, 9 and 17 in exfoliated cells in urine. This assay also has low sensitivity (75.6%) and specificity (84.8%)11. Clearly, accurate diagnostic methods are lacking for diagnosis of bladder cancer during early stages for screening.…”

mentioning

confidence: 99%

An integrated double-filtration microfluidic device for isolation, enrichment and quantification of urinary extracellular vesicles for detection of bladder cancer

Liang

Kong

Zhou

et al. 2017

Sci Rep

222

181

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Extracellular vesicles (EVs), including exosomes and microvesicles, are present in a variety of bodily fluids, and the concentration of these sub-cellular vesicles and their associated biomarkers (proteins, nucleic acids, and lipids) can be used to aid clinical diagnosis. Although ultracentrifugation is commonly used for isolation of EVs, it is highly time-consuming, labor-intensive and instrument-dependent for both research laboratories and clinical settings. Here, we developed an integrated double-filtration microfluidic device that isolated and enriched EVs with a size range of 30–200 nm from urine, and subsequently quantified the EVs via a microchip ELISA. Our results showed that the concentration of urinary EVs was significantly elevated in bladder cancer patients (n = 16) compared to healthy controls (n = 8). Receiver operating characteristic (ROC) analysis demonstrated that this integrated EV double-filtration device had a sensitivity of 81.3% at a specificity of 90% (16 bladder cancer patients and 8 healthy controls). Thus, this integrated device has great potential to be used in conjunction with urine cytology and cystoscopy to improve clinical diagnosis of bladder cancer in clinics and at point-of-care (POC) settings.

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Evaluation of urovysion and cytology for bladder cancer detection

Cited by 133 publications

References 43 publications

A prospective comparison of UroVysion FISH and urine cytology in bladder cancer detection

A prospective comparison of UroVysion FISH and urine cytology in bladder cancer detection

The Paris System for Reporting Urinary Cytology: The Quest to Develop a Standardized Terminology

An integrated double-filtration microfluidic device for isolation, enrichment and quantification of urinary extracellular vesicles for detection of bladder cancer

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