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    UROVYSION® BLADDER CANCER KIT TEST

    PersonalizeDx adheres to the FDA-approved labeling for UroVysion

    The UroVysion® Bladder Cancer Kit, developed in 2001, is the first FDA-approved urine-based molecular test for bladder cancer. 

    UroVysion, as run by PersonalizeDx, adheres to the FDA-approved labeling for UroVysion, without modifications to 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 (a bladder scope procedure performed in the urologist’s office) provides a high balance of sensitivity1 (97%) and overall specificity (93%), as indicated in the assay package insert.

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    More information about bladder cancer can be found at www.bcan.org and www.auanet.org.

     

    FOR IN VITRO DIAGNOSTIC USE

    1 Halling KC et al, 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.