Additional UroVysion Information

Welcome

This section provides the information you need to know: 

• What is Bladder Cancer?
• Bladder Cancer Diganosis & Treatment
• Doctor's Discussion Guide
• Helpful Resources & Links

What is Bladder Cancer?

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:

• The bleeding may be occasional and short-lived.
• There is likely to be no pain associated with the bleeding.

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

• Do Not Smoke
• Avoid Occupational Exposures to Certain Chemicals
• Drink Plenty of Liquids
• Incorporate Fruits and Vegetables into Your Diet

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:

• Aggressiveness of tumor ("Grade")
• Whether the tumor has invaded the muscle layer
• The location of the tumor in the bladder
• Whether the tumor has spread to other parts of the body
• Your age and general health

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.

Doctor's Discussion Guide

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:

• What is the stage of my bladder cancer and where has it spread?
• What are my options for treatment? What would you recommend?
• What side effects or risks should I expect with the different treatment options?
• How long will my treatment take and what is the follow-up?

Helpful Resources and Links

Welcome

This section provides the information you need to know:

• Bladder Cancer Diagnosis

• Information & Resources

Bladder Cancer Diagnosis

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.

• Know Before You See: Detect molecular changes before morphological changes are visible.

• The Difference is Clear⁵

• Higher Sensitivity than Cystoscopy Alone
• Initial diagnosis of bladder cancer in patients with hematuria
• UroVysion is useful for reflex testing in the event of atypical cytology cases with equivocal or negative cystoscopy.
• When cytology is unclear
• Cystoscopy in combination with UroVysion has been shown to be significantly more sensitive than cystoscopy alone.

• Combined Sensitivities

• Greater Sensitivity Across Every Stage and Every Grade^{6, 7, 8}

• Positive UroVysion predicts recurrence during BCG therapy⁹ 

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.

• Positive UroVysion predicted tumor recurrence at all time points
• The risk of tumor recurrence increased with each additional positive UroVysion result
• Earlier conversion from negative to positive UroVysion result was associated with a higher risk of disease recurrence

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 Kit Package Insert 

Information And Resources

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

BCAN › 

The Bladder Cancer Advocacy Network is dedicated to public awareness about bladder cancer.

Abbott Molecular Homepage › 

Homepage for Abbott Molecular, a global molecular diagnostics provider.

CMS Medicare Fee Schedules › 

Center for Medicare & Medicaid Services Physician Fee Schedule. 

Welcome

This section provides the information you need to know:

• Why UroVysion?
• Training
• Information & Resources 

Why UroVysion?

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

• Any test approved by the FDA for this purpose has gone through rigorous testing to validate the analytical and clinical validity of the test. 

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)

• 9p21 deletion is a common genetic alteration in pTa tumors¹²
• Loss of 9p21 is thought to occur early in the development of papillary and flat urothelial neoplasia¹¹
• Homozygous loss of 9p21 probe was detected in 3-8% of bladder cancer cases tested in UroVysion clinical trials¹²

Controlled scientific studies conducted demonstrating validity of test results across different variables and testing parameters

• High specificity, 100% in healthy subjects and urology patients without prior history or clinical evidence of bladder cancer
• Therapeutic agents or other benign conditions normally present in bladder cancer patients will not interfere with results as demonstrated by assay interference studies with 31 factors. 
• Adherence to PI specimen collection and transport instructions have been studied and shown not to interfere with results
• Reproducibility study at four independent sites

Proven clinical utility backed by more than 10 years of use with dozens of independent peer studies and publications

• Strong clinical 3rd party proof sources in well-respected journals with over 40 peer written and reviewed publications
• Widespread reimbursement based on unsurpassed clinical evidence
• More than an innovative test, it is routinely used by urologist worldwide over than past 10+ years
• Included in guidelines across the globe such as NCCN, NICE, AUA, EUA, and International Consultation of Urologic Diseases by practicing urologists

Provides insight throughout the clinical pathway and patient care continuum

• Initial diagnosis of bladder carcinoma in patients with hematuria 
• Clarify equivocal results
• When cytology is unclear
• Subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer
• Predict recurrence during BCG therapy

Training

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:

• Overview of the application of UroVysion in bladder cancer and trial data
• Overview of specimen preparation for the UroVysion assay
• Specimen pretreatment and hybridization protocols
• Troubleshooting the assay
• Microscope filter requirements
• Use of the ThermoBrite and an overview of the VP 2000 FISH Processor
• Scoring and interpretation of results

Training Schedule

For all training inquiries, please email training@abbottmolecular.com.

For additional information call:

US: 800-553-7042

Global: (+49) 6122.580

Information And Resources

Useful Links

BCAN › 

The Bladder Cancer Advocacy Network is dedicated to public awareness about bladder cancer.

Abbott Molecular Homepage › 

Homepage for Abbott Molecular, a global molecular diagnostics provider.

CMS Medicare Fee Schedules › 

Center for Medicare & Medicaid Services Physician Fee Schedule.

UroVysion is included in the US guidelines

• NCCN (2016) guidelines include UroVysion as it is the only FDA-approved FISH test: “Consideration may be given to FDA-approved urinary biomarker testing by fluorescence in situ hybridization (FISH).”
• AUA (2016) Guidelines include UroVysion by name: “In a patient with NMIBC, a clinician may use biomarkers to access response to intravesical BCG (UroVysion FISH) and adjudicate equivocal cytology (UroVysion FISH and Immunocyt).”

1. www.bacan.org/facts accessed November 4, 2016
2. http://www.cancer.gov/cancertopics/wyntk/bladder/page11. Accessed November 4, 2016. 
3. http://www.cancer.gov/cancertopics/wyntk/bladder/page15. Accessed November 4, 2016.
4. Crawford, ED, Intravesical therapy for superficial cancer: need for more options, J Clin Oncol. 2002 Aug; 20 (15): 3185-3186.

5. Sarosdy MF, Kahn PR, Ziffer MD, et al. J Urol. 2006 Jul; 176 (1): 44-47.

6. Schlomer BJ, et al. J Urol. 2010 Jan; 183 (1): 62-67 

7. Sarosdy MF, Kahn PR, Ziffer MD, et al. J Urol. 2006 Jul; 176(1): 44-47.

8. Halling KC et al. J Urol. 2000; 164: 1768-1775

9. Reprinted from The Journal of Urology, Vol. 187, Issue 3, Ashish M. Kamat, Rian J. Dickstein, et al, Use of Fluorescence In Situ Hybridization to Predict Response to Bacillus Calmette-Guèrin Therapy for Bladder Cancer: Results of a Prospective Trial, Page 862-867, © 2012, with permission from Elsevier.
10. UroVysion Package Insert 30-608385/R7
11. Bubendorf, Acta Cytologica, 2011 and he references Knowles MA, Scand J Urol Nephrol Suppl, 2008
12. AM Data on File
13. Sensitivity for cystoscopy alone and UroVysion plus cystoscopy was computed from primary data presented in Table 1 of Halling et Al, J of Urology, November 2000, Vol. 164, Issue 5, Page 1770