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    UROVYSION TESTING

    The UroVysion Option: All that’s required is a simple urine sample

    UroVysion, a molecular test for bladder cancer, is an option to be discussed with your physician. You simply furnish a urine specimen, and your physician orders the molecular UroVysion test, which provides a positive or negative result, typically within 72 hours.

    See UroVysion at a Glance

    When You Receive Your Test Results...

    The UroVysion test is particularly sensitive (100%) among the most severe tumors. This statistic is significant for women, in whom bladder cancer often is not detected until the later, Tis stage – cancer that is only in the innermost lining of the bladder and classed as "carcinoma in situ" (CIS or Tis). 1

    If your UroVysion test is positive, you must see a urologist immediately for a workup that can determine the cancer’s stage and grade as well as the best treatment therapies. If UroVysion is negative, your physician should follow standard guidelines for managing intermittent hematuria and persistent hematuria; or, alternatively, refer you to a urologist for a cystoscopy (bladder scope), upper tract imaging, and/or other procedures, as recommended by the American Urological Association, in an effort to ascertain the causes of persistent or intermittent hematuria. 

    UroVysion is used as an aid (in conjunction with, and not in lieu of, standard diagnostic procedures) in the detection of bladder cancer in patients with hematuria.

    PersonalizeDx is a CLIA-certified clinical laboratory that runs UroVysion, the only FDA-approved urine-based molecular test for the detection of bladder cancer. A FISH-based (fluorescence in situ hybridization) test, UroVysion uses four DNA probes. UroVysion is used in conjunction with and not in lieu of standard diagnostic procedures, as an aid in the initial diagnosis of bladder carcinoma in patients with hematuria and also in the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

    UroVysion Clinician Benefits

    • Detects chromosomal abnormalities associated with the development and recurrence of bladder cancer.
    • Delivers positive/negative results in suspicious cystoscopy or atypical cytology cases.
    • Shows 100% sensitivity among the most severe tumors (T2 and Tis).
    • Performs without interference in the presence of substances such as BCG, Mytomycin C, and Thiotepa in urine samples.

     

    Reference:

    1. Halling KC, King W, Sokolova IA, et al. A comparison of cytology and fluorescence in situ hybridization for the detection of urothelial carcinoma. J Urol, 2000; 164; 1768-1775.

    Intended Use: 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.

    Warnings and Limitations

    1. The UroVysion Kit has been optimized for identifying and quantitating chromosomes 3, 7, and 17, and locus 9p21 in human urine specimens.
    2. The performance of the UroVysion Kit was validated using the procedures provided in the package insert only. Modifications to these procedures may alter the performance of the assay.
    3. The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
    4. UroVysion assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate, e.g., the presence of excessive granulocytes or massive bacteruria.
    5. Technologists performing the UroVysion signal enumeration must be capable of visually distinguishing between the red and green signals.
    6. Positive UroVysion results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract related cancers—e.g., ureter, urethra, renal, and/or (in males) prostate—and further patient follow-up is justified. In a study conducted on patients with hematuria, 3 patients whose initial bladder cystoscopy was negative, were subsequently diagnosed with renal cancer within 6 months of this initial study visit. All 3 of these cases tested positive by UroVysion.
    7. If UroVysion results are negative, but standard clinical or diagnostic tests (e.g., cytology, cystoscopy) are positive, the standard procedures take precedence over the UroVysion test. Although the UroVysion Kit was designed to detect genetic changes associated with most bladder cancers, there will be some bladder cancers whose genetic changes cannot be detected by the UroVysion test.
    8. Stage Ta solitary tumors smaller than 5mm could not be detected by UroVysion FISH. UroVysion FISH results are dependent on the amount of tumor cells that are deposited on the slide.

     

    Caution: United States Federal law restricts this device to sale and distribution to, or on the order of, a physician or a clinical laboratory; use is restricted to, by, or on the order of a physician.

     

    FOR IN VITRO DIAGNOSTIC USE ONLY