ABBOTT PARK, Ill., May 17 /PRNewswire-FirstCall/ -- A review of multiple studies in the journal Urology indicates that UroVysion(R), a DNA-based urine test that detects key genetic changes in bladder cells, showed favorable clinical attributes not found in other available biomarkers in the detection of bladder cancer.
UroVysion, the first and only test approved by the U.S. Food and Drug Administration that uses DNA probes to identify chromosomal abnormalities associated with bladder cancer, is also known as “molecular cytology” because it assesses both morphologic cellular changes of conventional cytology and molecular DNA changes. The test is based on Abbott’s proprietary fluorescence in situ hybridization (FISH) technology.
In the March 2006 supplement of Urology, one expert, J. Stephen Jones, M.D., of the Glickman Urological Institute, Cleveland Clinic Foundation, authored a review of nine published studies that compared UroVysion(R) to conventional cytology. In the reviewed studies, UroVysion outperformed conventional urine cytology -- a long-time standard test used in the examination of individual cells and small clusters of cells -- across all stages and grades of bladder cancer. He also noted that UroVysion detected recurrent cancer before the development of lesions visible by cystoscopy, the visual examination of the bladder with an endoscopic tool inserted through the urethra.
“Many urologists have historically overestimated the sensitivity of cystoscopy, which could explain the high rate of cancer recurrence after complete removal of visible tumors,” Dr. Jones said. “We found that molecular cytology demonstrated an increased risk for tumor recurrence when it is positive and the cystoscopy is negative.”
In other key findings, UroVysion: -- Excelled when combined with cystoscopy. In one study, UroVysion, used in conjunction with cystoscopy, detected 97 percent of bladder tumors whereas the traditional cytology in tandem with cystoscopy detected 88 percent of tumors; and -- Better detected high-grade urothelial carcinoma, such as carcinoma in situ (CIS), a high-grade tumor of flat appearance that is often difficult to detect via cystoscopy. High-grade tumors, like CIS, have the greatest chance of progression and death if undiagnosed and untreated. Across the reviewed studies, FISH detected 96 percent of these worrisome cases, whereas cytology detected 71 percent. -- Is not affected by infection, hematuria (blood in urine), instrumentation (e.g., cystoscopy) or bacillus Calmette-Guerin (BCG) immunotherapy, the most commonly used agent for treatment of bladder cancer.
The March supplement to Urology is based on a meeting of medical experts, held on May 20, 2005, in San Antonio, Texas, to discuss the diagnosis and treatment of bladder cancer. The findings presented reflect the collective opinion of the panel. The meeting was jointly sponsored by the Postgraduate Institute for Medicine and Dane Garvin, Ltd. The meeting and publication of the proceedings were made possible, in part, by an unrestricted educational grant from Abbott.
Further data regarding the clinical benefits of UroVysion appeared in the December 2005 supplement to Urology. In that supplement, which featured prominent bladder cancer thought leaders from around the world, the International Consensus Panel on Cytology and Bladder Tumor Markers conducted extensive analyses of published studies of various marketed and in-development tumor markers. The summary findings of that independent consensus panel concluded that, of the marketed products, UroVysion:
-- Demonstrated high sensitivity to detect high-grade and high-stage tumors (83 percent to 97 percent), including carcinoma in situ (about 100 percent). -- Showed overall sensitivity in the studies that varied between 69 percent and 87 percent, with a sensitivity to detect low-grade (36 percent to 57 percent) and low-stage (62 percent to 65 percent) tumors. -- Exhibited high specificity across all grades and stages of tumors (>90 percent).
“The findings published in Urology confirm that UroVysion is a superior test as an aid in the detection of bladder cancer,” said Timothy Stenzel, M.D., Ph.D., medical director, Abbott Molecular. “Because of its high sensitivity and its unique ability to detect chromosomal change, UroVysion provides physicians with deeper insight into detection of high-risk urothelial carcinoma and helps guide important treatment decisions.”
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
CONTACT: Don Braakman of Abbott, +1-224-361-7246
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