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Welcome to the UroVysion additional information page, brought to you by Abbott Molecular. The UroVysion page aims to provide a wealth of valuable information for patients, clinicians, and laboratory professionals related to bladder cancer and the UroVysion molecular test.
Welcome
This section provides the information you need to know:
Definition
Bladder cancer is a disease in which certain cells in the bladder become abnormal and multiply without control or order. This buildup of extra cells often form a mass of tissue called a growth or tumor. Tumors in the bladder can be begin (not cancer) or malignant (cancer). Most bladder cancer develops in the urothelium (innermost lining of the bladder), however, some can grow into deeper layers.
In general, bladder cancer is a treatable disease but highly recurrent. This means that there is a high chance of the cancer recurring (50%-75%).1 Early diagnosis is associated with better treatment results and a greater chance or permanent remission. Ongoing monitoring and accurate detection of the disease recurrence are keys to improving the survival rates for bladder cancer.
Bladder Cancer Signs/Symptoms2
The most common sign of bladder cancer is painless gross hematuria, visible blood in the urine. This important sign is sometimes ignored which can lead to a delay in diagnosis.
It is ignored for two main reasons:
It is important to note that blood in the urine isn’t always associated with bladder cancer. Other symptoms include irritation when urinating and urgency, frequency and a constant need to urinate. In the presence of these symptoms, it is important to inform a physician to allow for early diagnosis and treatment.
Stages of Bladder Cancer
Risk Factors
Smoking
Smokers are more than twice as likely to get bladder cancer as nonsmokers.
Race
Whites are about twice as likely to develop bladder cancer compared with African Americans and Hispanics.
Gender
Men get bladder cancer at a rate 4 times greater than women.
Increasing Age
Over 70% of people with bladder cancer are older than 65 years old.
Occupational Exposure
The industries carrying highest risks include the makers of rubber, leather, textiles, and paint products as well as printing companies.
Reduce Your Risk
Bladder Cancer Diagnosis & Treatment
How is Bladder Cancer Diagnosed?
If you have symptoms that suggest bladder cancer, your doctor will try to find out what's causing the problem. You may have a physical exam. Urine tests are used in combination with other tests and procedures as aids to diagnose bladder cancer and other urologic disorders. Initially, the lab checks your urine for hematuria (blood). The UroVysion Bladder Cancer Kit is a molecular test that detects genetic abnormalities within cells of the bladder. These abnormalities are known to be associated with bladder cancer. Urine Cytology is a test that is used to look for abnormal cells in the urine that are known to be associated with bladder cancer.
Diagnostics Methods
Cytoscopy
Cystoscopy is a test that helps your doctor look at the inside of the bladder and the urethra using a thin, lighted instrument with a tiny camera attached called a cystoscope. The cystoscope is inserted into the urethra and slowly advances toward the bladder to help detect abnormalities. Tiny samples of tissue can be removed (biopsy) for further study.
Biopsy:
Your doctor can remove samples of tissue with the cystoscope. A pathologist then examines the tissue under a microscope. The removal of tissue to look for cancer cells is called a biopsy. In most cases, a biopsy is the only sure way to tell whether cancer is present.
For a small number of patients, the doctor removes the entire area with cancer during the biopsy. For these patients, bladder cancer is diagnosed and treated at the same time.
Urine Test - UroVysion
UroVysion is a Molecular diagnostic test that can assist your Urologist with bladder cancer detection by highlighting DNA abnormalities. UroVysion requires a urine sample.
UroVysion is the only urine-based molecular test approved by the FDA to aid in the diagnosing and monitoring of bladder cancer. it is backed by more than 10 years of scientific data and is used by urologists worldwide.
How is Bladder Cancer Treated?3
Treatment options for people with bladder cancer are surgery, chemotherapy, biological therapy, and radiation therapy. You may receive more than one type of treatment.
The treatment that's right for you depends mainly on the following:
You may have a team of specialists to help plan your treatment. Your doctor may refer you to a specialist, or you may ask for a referral. You may want to see a urologist. Other specialists who treat bladder cancer include urologic oncologists, medical oncologists, and radiation oncologists.
Your health care team may also include an oncology nurse and a
registered dietitian. If your treatment involves surgery to remove the bladder, a wound, ostomy and continence nurse may also be part of your team. Your health care team can describe your treatment choices, the expected results of each, and the possible side effects. You and your health care team can work together to develop a treatment plan that meets your needs.
Helpful Questions To Discuss With Your Doctor
It is important for you to have honest, open discussions with your cancer care team. Some questions to consider:
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Welcome
This section provides the information you need to know:
Early diagnosis is associated with better results from treatment options and a greater change of permanent remission.
Bladder cancer presents many clinical challenges.
Low-grade tumors have a 50% to 70% chance of recurrence
T1 tumors have a 25% to 30% risk of progression to muscle-invasive disease
Grade 2 or 3 tumors have an ~20% higher chance of progression to muscle-invasive disease than grade 1 tumors
Although cystoscopy and cytology are the current standard of care for the diagnosis and surveillance of bladder cancer, they have limited sensitivity, which can lead to uncertainty in diagnosis or monitoring.
UroVysion Can Help4
The UroVysion Bladder Cancer Kit is a proven, widely utilized test that detects chromosomal abnormalities to add molecular precision to cystoscopy and cytology. It can help physicians detect abnormalities before a tumor is visible —a primary reason many urologists ask for UroVysion.
UroVysion has been studied in multi-centered blinded comparative studies involving hundreds of patients. These and additional studies have established the following clinical benefits.
There is proof that cystoscopy, in combination with UroVysion, has been shown to be significantly more sensitive than cystoscopy alone.
Non-muscle invasive bladder cancer (NMIBC) patients undergoing BCG therapy with positive UroVysion results were found to be 3 to 5 times more likely to have tumor recurrence vs. patients with negative UroVysion results.
BCG treatment produces a highly inflammatory response that visual inspection of the bladder for tumor recurrence is very difficult for the duration of the BCG treatment. UroVysion is DNA based, thus performs without interference in the presence of BCG.
High Negative Predictive Value of 94.1%10
A high Negative Predictive Value (NPV) demonstrates that UroVysion can correctly identify the patients that are responding to treatment.
UroVysion - For Results Beyond the Scope
UroVysion - The Power of Definite Results
UroVysion - For Results You Can Trust
UroVysion - The Power of Molecular Results
Useful Links
The Bladder Cancer Advocacy Network is dedicated to public awareness about bladder cancer.
Homepage for Abbott Molecular, a global molecular diagnostics provider.
Center for Medicare & Medicaid Services Physician Fee Schedule.
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Welcome
This section provides the information you need to know:
UroVysion is the only FDA approved and CE marked urine-based molecular test as an aid for initial diagnosis of bladder cancer in patients with hematuria and subsequent monitoring for tumor recurrence in patients with previously diagnosed bladder cancer
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)
Controlled scientific studies conducted demonstrating validity of test results across different variables and testing parameters
Proven clinical utility backed by more than 10 years of use with dozens of independent peer studies and publications
Provides insight throughout the clinical pathway and patient care continuum
UroVysion Traning
This two-day seminar will offer general training in the basic biological principles of FISH through wet-laboratory exercises, lectures, discussion, and hands-on time, where applicable. Subjects that will be covered include:
Training Schedule
For all training inquiries, please email training@abbottmolecular.com.
For additional information call:
US: 800-553-7042
Global: (+49) 6122.580
Useful Links
The Bladder Cancer Advocacy Network is dedicated to public awareness about bladder cancer.
Homepage for Abbott Molecular, a global molecular diagnostics provider.
Center for Medicare & Medicaid Services Physician Fee Schedule.
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UroVysion is included in the US guidelines
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Sarosdy MF, Kahn PR, Ziffer MD, et al. J Urol. 2006 Jul; 176 (1): 44-47.
Schlomer BJ, et al. J Urol. 2010 Jan; 183 (1): 62-67
Sarosdy MF, Kahn PR, Ziffer MD, et al. J Urol. 2006 Jul; 176(1): 44-47.
Halling KC et al. J Urol. 2000; 164: 1768-1775
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UroVysion provides insight throughout the bladder cancer clinical pathway setting a high standard for bladder cancer detection and bringing clarity to bladder cancer monitoring.
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