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    UROVYSION® BLADDER CANCER KIT AS AN AID

    UroVysion can aid in the earlier diagnosis and treatment of bladder cancer

    Many patients see a urologist when blood is detected in the urine (hematuria). According to the National Kidney and Urologic Disease Information Clearinghouse (NKUDIC), a service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institute of Health, several conditions can cause hematuria, most of them not serious. However, the National Cancer Institute notes that, “Seventy percent of patients with bladder cancer have superficial disease at presentation. Hematuria is the most common presenting sign, occurring in about 90% of cases. Hematuria may be intermittent, so a urinalysis without red blood cells does not exclude a diagnosis of urothelial cancer.”

    The overwhelming majority of patients who have microscopic hematuria do not have cancer. Nonetheless, urologists seeking to rule out bladder cancer often perform or order one or more standard diagnostic procedures. According to the National Comprehensive Cancer Network's (NCCN) Practice Guidelines for Bladder Cancer, the initial evaluation may include patient history, physical exam and office cystoscopy, followed in the presumptive clinical stage by imaging of the upper tract collecting system, cytology and pelvic CT.

    For decades, urologists have relied on urine cytology, which studies individual cells to detect abnormal cells, to test for bladder cancer. Now there is UroVysion, a molecular test intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid in the initial diagnosis of bladder carcinoma in patients with hematuria and in the monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

    UroVysion can deliver these benefits:

    • Detects chromosomal abnormalities associated with the development and progression of bladder cancer
    • Demonstrates improved sensitivity as compared to voided urine cytology (Sarosdy, M.F., J Urol, 2002. Sarosdy, M.F., J Urol, 2006)
    • May detect bladder cancer recurrence up to 6 months sooner than current diagnostic methods (Halling, Sokolova, Journal of Urol, 2000)

    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