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36782: Bladder Cancer, Fish, Part C Print View
Bladder Cancer, FISH      

1 Urine 50 ( ) mL   Refrigerated - 72 Hour(s)/Room Temperature - 72 Hour(s)  
  Bladder washing   Refrigerated - 72 Hour(s)/Room Temperature - 72 Hour(s)  

The use of FISH following an atypical cytology can be helpful, as a negative FISH result generally favors a reactive, benign process, although it does not exclude low-grade urothelial neoplasia. Atypical urine cytology findings are frequently reported after conservative treatment for non-invasive bladder cancer. In this setting, a positive FISH result has been shown to indicate persistent or recurrent urothelial carcinoma. Non-invasive, superficial cancers can usually be cured, especially when well differentiated. Many bladder cancers, however, will recur: despite complete tumor resection, about 66% of patients will have a recurrence within 5 years and 88% within 15 years. Frequent monitoring (up to four times per year) for early detection of recurrence is key to increased survival of these patients. Traditionally, cystoscopy-guided biopsy, followed by histology, has been used for initial diagnosis, and cystoscopy and voided urine cytology (VUC) have been used for monitoring. Vysisr UroVysionr is a molecular cytology test that detects aneuploidy of chromosomes 3, 7, and 17 and deletion of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens. In a study of 497 patients with hematuria, the Vysis UroVysion test showed diagnostic sensitivity of 69% and specificity of 78% compared with cystoscopy followed by histology. The positive and negative predictive values were 27% and 95%, respectively (prevalence, 10.8%). Thus, the Vysis UroVysion test appears useful for diagnosis of bladder cancer in patients with hematuria. Researchers have found that increased chromosomal instability and aneuploidy, such as that detected by the Vysis UroVysion test, are characteristic of bladder tumor progression. Due to its high specificity (~96%) and increased sensitivity (Table), the Vysis UroVysion test is useful for early detection of bladder cancer recurrence when used in conjunction with c

Urine or Bladder washings: A urine preservative transport kit,
with handling instructions, is available upon request.

Perform urine or bladder washings collection (50 mL) at the
physician's office or Patient Service Center (PSC) in a sterile 100 mL
urine specimen container. Mix voided urine or bladder washings with
CytoLyt(R) or ethanol 50% in a 1:1 solution. Alternatively, mix urine
or bladder washings with preservative Carbowax(TM) (2% polyethylene
glycol in 50% ethanol) 2:1 (v:v).

It is recommended that specimens be processed within 72 hours of
collection. Samples received without preservative will be assayed;
any study under these conditions yielding insufficient cells or an
abnormal result should have a follow-up study with urine in a
a preservative. Cold packs are recommended during transportation. If
bladder washing is not shipped immediately after collection,
refrigerate immediately (do not freeze). Under no circumstances should
bladder washing specimens be stored or shipped at temperatures at or
above 37 degrees C.

Specimen viability decreases during transit. Send specimen
to testing lab for viability determination.
Setup Schedule

Reported (Analytical Time)
4 days

CPT Code

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Fluorescence in situ Hybridization (FISH)
Assay Category: FDA Exempt/Approved/Cleared/Modified Fish or Molecular
Transport Temperature: Refrigerated (Cold packs to maintain above 37 degrees C, but not frozen)
Frozen: Unacceptable
Reject Criteria: Do not send first morning specimen
Specimen Requirements:
Preferred: Urine or bladder washing collection (50 mL) in a sterile 100 mL urine specimen container. Mix voided urine or bladder washing with CytoLytr or ethanol 50% in a 1:1 solution. Alternatively, mix urine or bladder washing with preservative Carbowax(TM) (2% polyethylene glycol in 50% ethanol) 2:1 (v:v).
Other Transport Container: Urine preservative transport kit

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