Fluorescence in situ Hybridization (FISH)/Computer Assisted Analysis/Microscopy
- May aid in diagnosis of urothelial carcinoma in individuals with hematuria
- Use to monitor for tumor recurrence in patients previously diagnosed with urothelial carcinoma
- Use to detect amplification of chromosomes 3, 7, 17, and deletion of the 9p21 locus
Related Tests
Microscopy
Qualitative Immunoassay
- Aids in management of patients with bladder cancer in conjunction with cystoscopy
- Qualitative assay detects bladder tumor-associated antigen in urine of patients diagnosed with bladder cancer
Urothelial carcinoma shows a high recurrence rate; therefore, ongoing, lifelong surveillance is necessary. Bladder cancer can be identified by enumerating morphologically abnormal cells with aneuploidy of chromosomes 3, 7, 17, or by the loss of both chromosomal 9p21 segments.
Molecular testing can be used in conjunction with other standard procedures for diagnosis or to monitor patients for recurrence of urothelial carcinoma. Compared with cystoscopy, molecular testing is noninvasive. The UroVysion FISH test is designed to detect chromosomal abnormalities associated with urothelial cell carcinoma in voided urine specimens.
Disease Overview
Incidence
The following are the estimated numbers of new urinary system cancer cases in the United States per year :
- Urinary bladder cancer: ~81,400
- Kidney and renal pelvis: ~73,750
- Ureter and other urinary organs : ~3,970
Symptoms
Two primary symptoms associated with urothelial carcinoma are :
- Hematuria
- Irritative voiding
Screening/Diagnosis Issues
Individuals complaining of mild hematuria are traditionally tested for the presence of neoplastic lesions with the following tests:
- Cytology
- More sensitive to high-grade lesions
- May miss low-grade papillary tumors
- Cystoscopy
- Can detect low-grade papillary tumors
Genetics
Variants
- Amplification of chromosomes 3, 7, 17
- Deletion of the 9p21 locus
Test Interpretation
Sensitivity/Specificity
- Clinical sensitivity: 68-81%
- Clinical specificity: 79-96%
Results
Result | Laboratory Finding |
---|---|
Positive |
Detection of ≥1 of the following numeric chromosomal abnormalities commonly associated with urothelial carcinomaa:
|
Negative |
Lack of evidence for the presence of numeric chromosomal abnormalities commonly associated with urothelial carcinoma within the cells collected in specimen |
aIn the absence of clinical documentation of urothelial carcinoma within the bladder, a positive result suggests the possibility of urothelial carcinoma or other urologic malignancy in the ureter, urethra, kidney, or prostate. Further clinical evaluation to exclude these tissues as a source of abnormal cells is recommended. |
Limitations
- Some urothelial cancers will not be detected
- Negative results in the presence of other symptoms/signs of urothelial carcinoma may suggest possibility of false-negative test result
- Gene variants or defects other than amplification of chromosomes 3, 7, or 17, and deletion (loss) of 9p21 locus are not detected
References
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ACS-Cancer Statistics Center 2020
American Cancer Society. Cancer Statistics Center. [Accessed: Apr 2020]
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27317986
Chang SS, Boorjian SA, Chou R, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. 2016;196(4):1021-1029. [Amended: 2020]
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NCCN - Bladder Cancer
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: bladder cancer. Version 3.2020. [Published: Jan 2020; Accessed: Mar 2020]
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Abbott - UroVysion Bladder Cancer Kit
Abbott Molecular. UroVysion Bladder Cancer Kit [package insert]. [Updated: Aug 2014; Accessed: Apr 2020]