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UroVysion, FISH Bladder Cancer

T151

The assay is an FDA-approved diagnostic assay for the detection of bladder cancer, designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens. May also be used in subsequent monitoring for tumor recurrence in previously diagnosed patients. 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.


Methodology: Fluorescence in situ Hybridization (FISH)
Performed: Varies
Reported: 3-4 days
Specimen Required: Collect: Random Urine -  33 ml urine

Specimen Preparation: Perform urine collection  at the physician's office or Patient Service Center (PSC) in a sterile urine specimen container. Mix voided urine with CytoLyt  a 1:1 solution (33 ml urine and 33 ml Cyto-Solution). See attached file.
OR  mix urine with CytoLyt  2:1 (33 ml urine and 15 ml Cyto-Solution).
It is recommended that specimens be processed within 72 hours of collection. 
Samples received without preservative will be assayed; any study under these conditions yielding insufficient cells or an abnormal result should have a follow-up study with urine in a preservative. 

Storage/Transport Temperature:
Refrigerated.
DO NOT FREEZE 

Stability:
Refrigerated 72 hours

Comment:
Specimen collection date is required.

NOTE: * This test is approved for all states. *


Performing Laboratory 
Lincoln Diagnostics LLC, NJ

CPT Code(s): 88120
Sample Report
Additional Information

Brochure


Clinical Use
  • Diagnose bladder cancer in patients with hematuria (in conjunction with standard diagnostic procedures)
  • Detect bladder cancer recurrence

Detect Bladder Cancer Recurrence up to Six Months Sooner than Other Diagnostic Methods

UroVysion's molecular cytology combines the strength of urine cytology (morphology) with molecular (DNA-based) technology to unequivocally detect the presence of cancer.

  • Offers greater sensitivity than tests such as cytology or biomarkers, which translates into fewer false negatives.
  • Earlier detection allows you to treat your patient's cancer more aggressively as needed
  • Detects high grade pT1 and pTis tumors that can be overlooked with traditional diagnostic methods and have high progression rates to muscle-invasive cancer
  • Provides results you can count on – UroVysion is the first FDA-approved genomic DNA-probe test for identifying early recurrence of bladder cancer
  • Not affected by BCG Immunotherapy

With UroVysion you now have a superior option to accurately manage bladder cancer recurrence.


Sensitivity

UroVysion is not only more sensitive than urine cytology by stage, but also more sensitive by grade.

Synonyms:
- Bladder Cancer
- Bladder Cancer FISH
- Bladder Tumor
- Bladder Tumor FISH
- FISH
- Urinary Tract Cancer
- Urothelial Carcinoma
- Urovysion

Contact a Accureference' Sales Representative, learn more about our testing services, and become a client

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