Urovysion™ Fish for Bladder Cancer

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Subject: Urovysion™ Fish for Bladder Cancer

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Definition

  • The UroVysion™ FISH test for bladder cancer is designed to detect, in cells shed into urine, the presence of aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus, using fluorescence in situ hybridization. These chromosomal abnormalities are commonly associated with urothelial carcinoma.

  • Reference ranges:

    • (Negative) absence of cells identified with numeric chromosomal aberrations associated with urothelial carcinoma

    • (Positive) presence of cells identified with numeric chromosomal aberrations associated with urothelial carcinoma

Use

  • The UroVysion™ FISH test is intended to be used in conjunction with standard diagnostic procedures for the primary diagnosis of bladder cancer in patients with hematuria and in subsequent monitoring for tumor recurrence.

Interpretation

Limitations

  • Mutations or genetic defects other than amplification of chromosomes 3, 7, or 17; or other than deletion of the 9p21 locus, will not be detected.

  • Minimum specimen volume ≥35 mL.

  • Specimens are stable to 72 hours only if fixed with Saccomanno or PreservCyt® fixative.

 
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