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The U.S. Food and Drug Administration (FDA) recently approved UroVysion™, a test that identifies genetic mutations, as an aid in the diagnosis of bladder cancer. The approval is for patients who have blood in their urine and are suspected of possibly having bladder cancer.

Bladder cancer is the fifth most common type of cancer in the United States, and causes approximately 13,000 deaths annually. The bladder is a hollow organ located in the lower pelvis that stores urine. If bladder cancer is detected and treated early, prior to its spread, cure rates remain high with standard therapy. However, once bladder cancer has spread from its site of origin, treatment is more aggressive and cure rates fall. Therefore, early detection in patients at high risk of developing bladder cancer, or those suspected of having bladder cancer, is important in providing optimal outcomes. Standard detection methods for determining the presence of bladder cancer include urine cytology (the examination of cells in the urine) and cystoscopy (the use of an illuminated tube that is inserted into the bladder so physicians can visualize the lining of the bladder for any abnormalities). If abnormalities are found during a cystoscopy, the physician will remove part or all of the suspicious-looking tissue to examine for the presence of cancer cells in the laboratory. Results from clinical studies are indicating that tests evaluating genetic changes or levels of proteins may provide more accuracy than urine cytology in the detection of bladder cancer when used with cystoscopy.

UroVysion™ is a type of laboratory test that can be performed with a urine sample. It tests for specific genetic changes within the cells that have been shed from the bladder and are in the urine. The specific genetic changes have been associated with an increased risk of the presence of bladder cancer. UroVysion™ was approved by the FDA in 2001, to be used in conjunction with cystoscopy, for the monitoring of a cancer recurrence in patients already diagnosed with bladder cancer.

The data leading to FDA approval of UroVysion™ as an aid in bladder diagnosis were results of a clinical trial that included 23 medical sites. The trial included 497 patients who had blood in their urine (hematuria). Patients gave urine samples, which were tested by UroVysion™, as well as standard urine cytology. Patients also underwent a cystoscopy. Overall, UroVysion™ detected nearly 69% of bladder cancers, while urine cytology only detected approximately 40%.

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The researchers concluded that UroVysion™ appears to be more effective in detecting bladder cancers than the standard urine cytology tests. UroVysion™ is to be used with cystoscopy, and may aid in the earlier detection of some bladder cancers, as well as detecting early recurrences. Patients who are to undergo a cystoscopy for possible bladder cancer may wish to speak with their physician regarding their individual risks and benefits of UroVysion™.

Reference: Abbott Laboratories. FDA Approves First Gene-Based Test, UroVysionTM. Available here. Accessed February 2005.