Background: For 2014, American Cancer Society estimated around 74,690 diagnosed cases and 15,580 deaths from bladder cancer.4 Today, it affects three times as many men as women. However, women have more advanced tumors than men at the time of diagnosis.5

Bladder Cancer affects urination habits and shares many symptoms with other less severe diseases such as infections, bladder stones or enlarged prostate. The most common symptom is blood in urine (haematuria). Identifying the cause as Bladder Cancer, allows for early diagnosis, proper referral, and improves the chances of successful treatment.

What is UroVysionTM? UroVysion™ is a urine test that looks for chromosome changes in bladder cancer cells and detects aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH). Results from the UroVy-sion should be used as an aid in initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

Why UroVysionTM?• It is the only urine-based molecular test approved by the FDA to aid in the diagnosing and monitoring of

bladder cancer.• UroVysion is backed by more than 10 years of scientific data.

Who can be tested? Anyone suspected of having bladder cancer.

Specimen Requirements: Urine in ThinPrep UroCyte Urine Collection Kit. For specific instructions refer to UroVysion™ FISH Collection Procedure.

Transport/Stability: Refrigerated specimen is stable for 72 hours. Ambient or frozen specimen will be rejected.

URoVySionTM FiSH - TeST #4445

Warnings and Limitations:1. Clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic

laboratory test results. 2. 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 prostate in males, 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 were positive by UroVysion.

3. 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 UroVysion 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.

4. Ta stage 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.

References:

1. Kamat, A.M., Dickstein, R.J., & et al. (2012). Use of Fluorescence In Situ Hybridization to Predict Response to Bacillus Calmette-Guérin Therapy for Bladder

Cancer: Results of a Prospective Trial. The Journal of Urology. 187(3), 862-867.

2. Schlomer, B.J, Ho, R., & et al. (2010). Perspective Validation of the Clinical Usefulness of Reflex Fluorescence

in Situ Hybridization Assay in Patients with Atypical Cytology for the Detection of Urothelial Carcinoma of

the Bladder. The Journal of Urology. 183(1), 62-67.

3. Halling, K.C., King, W., & et al. (2000). A Comparison of Cytology and Fluorescence in situ Hybridization for

the Detection of Urothelial Carcinoma. The Journal of Urology. 164(5), 1768-1775.

4. American Cancer Society. (2015). What are the key statistics about bladder cancer? Retrieved from

http://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-key-statistics.

5. National Cancer Institute. (2010). What You Need To Know About Bladder Cancer. Retrieved from http://

www.cancer.gov/Publications/patient-education/wyntk-bladder-cancer.

Greater Sensitivity in Patients with Hematuria2,3

Continually studied for further clinical utility: UroVysion is useful for reflex testing in the event of atypical cytology cases with equivocal or negative cystoscopy. 4

Diagnosis & Monitoring for RecurrenceA positive UroVysion result predicts recurrence during BCG Therapy1. 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.

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