DES PLAINES, Ill., July 20 /PRNewswire-FirstCall/ -- A study published in the July 2006 edition of Journal of Urology has shown that UroVysion(TM), a DNA-based urine test that detects important genetic changes in bladder cells, has almost twice the sensitivity of conventional urine cytology tests, the current gold standard, as an aid for the initial diagnosis of bladder cancer in patients with hematuria (blood in urine) suspected of having bladder cancer. Sensitivity refers to the likelihood that a patient with bladder cancer will have a positive test result and is a standard indicator of the predictive value of a diagnostic test.
According to the authors of the study, hematuria is the symptom most commonly associated with bladder cancer. But because bladder cancer only accounts for about 10 percent of patients with hematuria, a delay between those first symptoms and diagnosis is not only common, it has been shown to adversely affect patient outcomes.
This prospective, blinded study involved 497 eligible patients with an average age of 63 from 23 clinical sites throughout the United States and Canada. All patients had confirmed hematuria within three months of enrollment. The results showed that UroVysion detected 69 percent of bladder tumors, while cytology detected 38 percent. When low grade, low stage (i.e., Ta Grade 1) tumors were excluded, UroVysion detected 83 percent of the cases, while cytology detected only 50 percent. Further, the “negative predictive value” or probability that negative UroVysion results were not associated with bladder cancer in this group was 98.5 percent.
“These data certainly argue strongly for the use of the UroVysion assay, particularly if urine cytology results are negative,” said Michael Sarosdy, M.D., of San Antonio, Texas, a urologic oncologist and lead investigator of the UroVysion study.
UroVysion is the first and only test approved by the U.S. Food and Drug Administration that uses DNA probes to identify up to four chromosomal abnormalities frequently associated with bladder cancer. UroVysion is also known as “molecular cytology” because it assesses both morphologic cellular changes of conventional cytology and molecular DNA changes. Intended as an aid to current diagnostic procedures, its unique ability to detect chromosomal change can provide deeper insight to the clinician in monitoring for tumor recurrence in patients previously diagnosed with bladder cancer and in the initial diagnosis in patients with hematuria suspected of having bladder cancer. UroVysion is based on Abbott’s proprietary fluorescence in situ hybridization (FISH) technology.
“This study further confirms the clinical benefit and superiority of UroVysion over the gold standard of cytology as an aid in the detection of bladder cancer,” said Timothy Stenzel, M.D., Ph.D., medical director, Abbott Molecular. “Because of its balance of high sensitivity and specificity, and its unique ability to detect chromosomal change, UroVysion is an important test, particularly for detection of high-risk bladder cancers.”
About Bladder Cancer
The American Cancer Society estimates that in 2006 there will be about 61,000 new cases of bladder cancer diagnosed in the United States (about 45,000 men and 17,000 women) and an estimated 13,000 deaths from the disease. There are approximately 600,000 in the United States living with diagnosed bladder cancer. Bladder cancer, the most common form of urothelial cancer, is the fourth most frequent cancer diagnosed in men, and 1 in 30 are at risk of developing it in their lifetime. Approximately 50 percent of patients will experience a recurrence within two years after an initial diagnosis of bladder cancer. This high rate of recurrence requires that patients be monitored up to four times a year for tumor recurrence.
Safety Information
For important safety information regarding UroVysion please visit http://www.urovysion.com .
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. FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate. Positive FISH 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. A negative FISH result does not rule out all bladder cancer, nor does it necessarily mean that an individual will not develop bladder cancer in the future.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott’s news releases and other information are available at the company’s Web site at http://www.abbott.com .
Source of bladder cancer statistics: http://www.cancer.org
Abbott
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