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The UroVysion Bladder Cancer Kit (UroVysion Kit) is FDA approved and designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
Cancer:
Bladder Cancer
Method:
Fluorescence in situ hybridization (FISH)
Approvals
Date
Cancer
Gene
Drug
By
02/08/02
FDA