UroVysion FISH
Bladder Cancer Detection by Vysis® Urovysion

Test Indication: The Vysis Urovysion®
Bladder Cancer FISH assay should be used as a noninvasive method to monitor urothelial carcinoma.

Method: Fluorescence in situ hybridization (FISH).

Specimen requirements: 50 ml (minimum). Note: First voided urine or bladder wash increases specimen cellularity.

Specimen type: Voided urine, bladder wash catheter urine, renal wash, ileal conduit, post cystotomy wash.

Collection and transport: Patients should be well hydrated prior to collection. Refrigerate specimen until preserved. Add an equal amount of 50% ethanol or CytoRich Red™ cytology preservative to 50-100 ml urine or washing/conduit specimen collected. Store at room temperature once preserved.

Fixation: 48 hours 2-8°C (without preservation) or 48 hour at room temperature with preservative, equal amounts 50-70% ethanol or CytoRich Red™ cytology preservative.

Causes for rejection: Specimen is 3 days (72 hours) or older (from date of collection), or specimen is less than 50 mL.

Specimen stability: Optimal 24-48 hours, (specimen cell viability is optimally high), 99% sensitivity and reliable reportable results for assay within this time frame.
Suboptimal- after 48 hours, (specimen cell viability is decreased), there is a higher probability of no reportable result for this assay due to insufficient cell viability.

Reference range: Normal profile.

Interpretative data: The Vysis Urovysion® Bladder Cancer FISH assay should be used as a noninvasive method to monitor urothelial carcinoma. These findings should be interpreted in association with other clinical and pathological findings. The Vysis®
Bladder Cancer Recurrence assay has been cleared by the U.S. Food and Drug Administration for voided urine samples from patients with transitional cell carcinoma of the bladder.

TAT: 2-3 days.
Test performed at US Labs, CLIA & CAP certified for High complexity testing CLIA I.D. #05D0923321 S

ICD9 code: Required on all patient requisitions.

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