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    ANSWERS TO COMMONLY ASKED QUESTIONS

    PersonalizeDx answers your concerns

    There is now a reliable molecular test that aids in the initial diagnosis of bladder cancer in patients with hematuria (blood in the urine) as well as in the subsequent monitoring for bladder cancer recurrence in patients who previously have been diagnosed with the disease. The following frequently asked questions are intended to provide background information to patients preparing to discuss bladder cancer with a urologist.

    How common is bladder cancer?

    The National Cancer Institute (NCI) estimated that in 2013 there would be 72,570 new cases of bladder cancer in the United States and 15,210 deaths from the disease.1

    Where is the bladder located?

    A hollow, muscular organ, the bladder is part of the urinary tract and is located in the lower abdomen. Urine is formed in the kidneys and travels down to the bladder through tubes called ureters. The bladder acts as a holding area for urine until it leaves the body through a tube called the urethra.

    How is bladder cancer treated?

    Treatment is a 2-part process:

    • Part one is diagnosis, which includes identification of the cancer, followed by determination of its stage (invasiveness of the cancer into other tissue layers) and grade (aggressiveness of the cancer cells).
    • Part two is treatment. Depending on the state and grade, the cancer may be treated with surgery (removal of the cancer), immunotherapy, chemotherapy, or radiation.

    With such a high bladder cancer recurrence rate and need for follow up, how does my urologist monitor my bladder cancer?

    The primary method to monitor is by cystoscopy. This is a medical procedure in which a cystoscope (a narrow tube and lens) is inserted into the bladder via the urethra. Local anesthetic or general anesthesia is often administered during this procedure. The urologist uses the cystoscope to look at the inside of the bladder for signs of cancer. If an area looks suspicious, the urologist can collect a small sample of the tissue (a biopsy) and send it to a testing lab that studies the tissue to determine whether cancer cells are present.

    To assist in the diagnosis, one of the following lab tests may be performed along with cystoscopy on a sample of your voided urine:

    • Urine Cytology Test: This microscopic test looks for abnormal-looking cells (potential bladder cancer cells) that were shed from the bladder lining into the urine.
    • Biomarkers: These tests look for specific molecules in the urine that are produced by cancer cells.
    • DNA Probe-Based Test: This test looks for genetic changes via fluorescence in situ hybridization (FISH) in bladder cells collected from voided urine.

    What makes the UroVysion DNA probe-based test so important?

    Cancer does not occur without genetic change. The UroVysion (FISH) test detects genetic changes, such as chromosomal abnormalities, that can occur in bladder cancer cells. UroVysion visually reveals chromosomal abnormalities associated with cancer. With UroVysion, by identifying as few as four bladder cells with abnormal chromosomes, a physician has an important tool, along with current standard diagnostic procedures, to aid in determining if bladder cancer is present. UroVysion, in conjunction with cystoscopy, can also be used to monitor for recurrent bladder cancer. Discuss the UroVysion test with your physician, because only your physician can order UroVysion. Ask your urologist to contact PersonalizeDx to request the UroVysion Bladder Cancer Kit by name.

    Is UroVysion paid for by my insurance?

    UroVysion is covered and reimbursed by most private and public insurance. PersonalizeDx bills your insurance company for the test. If you have questions about payment or insurance coverage, contact PersonalizeDx at 1-877-429-6643.

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    Reference Resources:

    1.  http://www.cancer.gov/cancertopics/types/bladder. Accessed February 20, 2014.

     

    Intended Use: The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and the 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