BLADDER CANCER FISH,PHD REVIEW

Message
"Specimens should be received at the laboratory within 72 hours postcollection for optimal testing. Specimens older than 72 hours will not be rejected; however, results not guaranteed. In these instances, clients should consider recollection if possible.
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Test Code
130080


Alias/See Also
"FISH, Bladder Cancer
Urothelial Carcinoma, FISH
UroVysion™, FISH
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CPT Codes
Call CPT operations at 800-222-7566, ext 6-8400 for coding.

Preferred Specimen
"Urine
50 mL urine mixed with preservative in TCC Monitoring kit
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Minimum Volume
"33 mL urine mixed with preservative in TCC Monitoring kit
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Instructions
"Step 1: Use the large, open cup in the kit to collect the urine specimen. First void of the day is preferred. Ensure that the urine specimen reaches the minimum fill line of 33 mL.

Step 2: Slowly pour urine into the smaller container to the maximum fill line of 90 mL.

Step 3: Tighten the lid until you hear a click in order to prevent leakage.
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Transport Container
"TCC Monitoring kit (PeopleSoft item N° 44921). Other containers that are accepted, but not recommended: PreservCyt® vial, Cytology Special Studies Kit (PeopleSoft item N° 3203), or sterile urine container with Carbowax® fixative (two parts urine; one par


Transport Temperature
Refrigerated


Specimen Stability
"Specimen should be refrigerated at 2°C to 8°C and shipped on cool packs. Do not freeze.
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Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
"Incorrect fixative; significant contamination with blood obscuring bacterial overgrowth; inadequate specimen cellularity
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Methodology
"Fluorescence in situ hybridization (including diagnostic interpretation by MD pathologist) "

Limitations
"Positive FISH results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract-related cancers (eg, ureter, urethra, renal, and/or prostate in males), and further patient follow-up may be helpful. Negative FISH results in the presence of other signs and symptoms of bladder cancer recurrence may need to be regarded as suspicious false-negative results; repeat testing may be indicated. Although the assay was designed to detect chromosome changes associated with most bladder cancers, there are some bladder cancers whose genetic changes are not targeted by this test
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Clinical Significance
"The assay 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 subjects with transitional cell carcinoma of the bladder. This assay does not detect other chromosomal or genetic alterations. Results are intended for use as a noninvasive method of monitoring for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The clinical interpretation of test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results.
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The CPT Codes provided in this document 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 payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.