UroVysion

A minimum of 33 mL urine

For the greatest yield of diagnostic material, a second-morning, clean-catch voided urine specimen should be collected, if possible. On the specimen collection cup, record patient information in the space provided. Collect urine in a routine manner in the specimen cup provided. If urine volume exceeds 60ml, discard excess urine (the total volume of urine must not exceed 60ml). [A minimum of 33ml of urine is required to perform the FISH assay for bladder cancer]. After the urine is collected, carefully pour the urine into the vial containing the fixative, taking care not to cross the fill line indicated on the label. Tightly secure cap on the Specimen Transport Bottle to prevent leakage. Place cup and absorbent pads into the biohazard bag. Tightly seal bag.

Preferred storage and shipping conditions are on ice packs (e.g., blue ice in Styrofoam™).

The UroVysion Bladder Cancer Kit (UroVysion Kit) is 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. Results from the UroVysion Kit are 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.

Specimen needs to be stored and transported refrigerated.

Specimens not fixed in PreservCyt®
Urine volume less than 33 mL
Specimen containers without two (2) patient identifiers

7 Days

In general, exfoliated transitional cells from voided or instrumented urine collection specimens are first cytologically examined, and, if the cells are atypical/suspicious for malignancy, the cells are "reflexed" for UroVysion testing.The Vysis® UroVysion™ Bladder Cancer Kit (UroVysion™ Kit) is approved for use by the U.S. Food and Drug Administration.