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    ABOUT UROVYSION® BLADDER CANCER KIT

    UroVysion As An Aid

    FISH / Molecular Diagnostics

    How UroVysion Works

    Clinical Performance

    Predictive Value

    UroVysion As An Aid

    UroVysion, the advanced molecular diagnostics generation of bladder cancer detection, aids—in conjunction with and not in lieu of standard diagnostic procedures—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.

    In 2001, UroVysion became the first FDA-approved urine-based molecular test for bladder cancer. UroVysion has these characteristics:

    • UroVysion’s sensitivity is better than the sensitivity of cytology for all stages and grades.1
    • UroVysion’s most pronounced benefit is for “serious” recurrences (CIS, high-grade or invasive).1
    • Detects chromosomal abnormalities associated with the development and progression of bladder cancer
    • Offers the best available combination of sensitivity and specificity1
    • Detects bladder cancer recurrence up to 6 months sooner than current diagnostic methods1

    UroVysion, as run by PersonalizeDx, adheres to the FDA-approved labeling for UroVysion, without modifications in procedures that potentially may alter the performance of the assay. Studies show that, in patients previously diagnosed with bladder cancer, UroVysion (in combination with cystoscopy) demonstrated a 97% sensitivity.1 The overall specificity of UroVysion was 93%, as indicated in the FDA-approved labeling for UroVysion.

    FISH / Molecular Diagnostics

    UroVysion provides important information based on the early detection of subtle changes in chromosomes found in patients' genes. This information may allow for the earlier diagnosis of bladder cancer and the monitoring for disease recurrence.

    How UroVysion Works

    The UroVysion Bladder Cancer Kit (UroVysion Kit) is FDA-approved and 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 the initial diagnosis of bladder carcinoma in patients with hematuria and the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

    UroVysion uses four DNA probes, each labeled with a different color fluorescent tag, that bind to specific gene sequences on human chromosomes. These probes reveal genetic abnormalities that may be associated with cancer.

     
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    Predictive Value

    UroVysion is used to monitor for recurrence of bladder cancer. An anticipatory positive UroVysion result can be predictive of bladder cancer recurrence. An anticipatory positive is defined as a positive/abnormal result, despite an initial negative cystoscopy/histology, where a tumor is subsequently identified by cystoscopy/histology.

    See the UroVysion package insert for more information about the positive predictive value (PPV) and negative predictive value (NPV) of UroVysion.

    Halling KC, King W, Sokolova IA, et al. A comparison of cytology and fluorescencein 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