Georgia Esoteric and Molecular Lab, LLC
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UroVysion™ By FISHTest Ordering Code: 2211CPT Codes: 88368 x 4Turnaround Time:2 - 3 business days Specimen:Submit a random voided urine specimen (minimum 35 mL) with an equal volume of PreservCyte or Carbowax (2% polyethylene glycol in 50% EtOH) preservative. For overnight shipping send urine specimen with cold packs. The specimen is stable for three days in a refrigerator. Clinical Significance:Numerical and structural chromosome abnormalities commonly associated with bladder cancer are observed within cells exfoliated into urine. Positive results in the absence of other clinical symptoms of bladder cancer suggest the possibility of urothelial carcinoma or another urological malignancy from another site. Confirmation of abnormal FISH findings by biopsy or cytology is important. Further clinical evaluation to exclude other sites as source of abnormal cells is recommended. Negative results suggest absence of chromosome abnormalities normally associated with recurrent bladder cancer within the cells exfoliated into urine. In presence of other clinical symptoms, negative results may suggest a false negative test. When false negative results are suspected, additional clinical evaluation should be done to exclude recurrent bladder cancer. Indications for Testing:Post-treatment monitoring of patients with known bladder cancer and cancer screening of adult patients with hematuria. Methodology:Fluorescent in situ Hybridization (FISH). Fluorescently labeled DNA probes representing specific regions of the genome are used to detect deletions and numerical abnormalities of chromosomes. UroVysion™ bladder cancer kit consists of four color, four probe mixture of DNA probes that detect aneuploidy for chromosomes 3, 7, and 17 and loss of the 9p21 locus in voided urine specimens from patients with recurrent bladder cancer. This test has been approved by the U.S. Food and Drug Administration (FDA) for diagnosis of recurrent bladder cancer and the initial diagnosis of transitional cell carcinoma of the urinary bladder. Reference Interval:POSITIVE: No evidence of numerical and structural chromosome abnormalities associated with bladder cancer recurrence detected. NEGATIVE: Numerical and structural chromosome abnormalities associated with recurrent bladder cancer are present. References:Information for Patients: http://www.urovysion.com/Patients_6.asp Information for Physicians: http://www.urovysion.com/HealthcareProfessionals_7.asp Degtyar P, Neulander E, Zirkin H, Yusim I, Douvdevani A, Mermershtain W, Kaneti K, Manor E . Fluorescence in situ hybridization performed on exfoliated urothelial cells in patients with transitional cell carcinoma of the bladder. Urology 2004, 63:398-401 Inoue T, Nasu Y, Tsushima T, Miyaji Y, Murakami T, Kumon H. Chromosomal numerical aberrations of exfoliated cells in the urine detected by fluorescence in situ hybridization: clinical implication for the detection of bladder cancer. Urol Res. 2000 Jan;28(1):57-61 Zhang FF, Arber DA, Wilson TG, Kawachi, MH, Slovak ML. Toward the validation of aneusomy detection by fluorescence in situ hybridization in bladder cancer: comparative analysis with cytology, cytogenetics, and clinical features predicts recurrence and defines clinical testing limitations. Clin Cancer Res. 1997, Dec;3(12 Pt 1):2317-28
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