FDA Approves First Gene-Based Test, UroVysion(TM), for Diagnosis of Patients Suspected of Having Bladder Cancer UroVysion shown to be more sensitive than established methods in detecting bladder cancer ABBOTT PARK, Ill., Jan. 25 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration has approved Abbott's UroVysion(TM) DNA probe assay for use as an aid in the initial diagnosis of bladder cancer in patients with hematuria (blood in urine) suspected of having bladder cancer. With this approval, UroVysion represents the first gene-based test available for both diagnosis and monitoring of bladder cancer recurrence. The test is designed to detect genetic changes in bladder cells in urine specimens using a proprietary technology known as fluorescence in situ hybridization or FISH. "UroVysion is significantly more sensitive than conventional methods for the detection of bladder cancer," said Michael Sarosdy, M.D., of San Antonio, Texas, a urologic oncologist and lead investigator of the UroVysion study. "This new use should allow physicians to make an earlier diagnosis, with earlier treatment," Dr. Sarosdy said. The FDA based its approval on a Premarket Approval Application (PMA) filed by Abbott in December 2003. Included in that filing were the results of a 23- site study of 497 patients presenting with hematuria. Results demonstrated that UroVysion had greater sensitivity than the most commonly used testing method to detect bladder cancer. The study compared UroVysion performed on urine samples to cystoscopy/histology testing methods and demonstrated a clinical sensitivity of 68.6 percent and a clinical specificity of 77.7 percent. Urine cytology was also performed and demonstrated a relative sensitivity of 39.2 percent and a relative specificity of 91.5 percent. "Studies have shown that early and accurate detection of bladder cancer is key as thousands die each year of this disease," said Mark S. Soloway, M.D., professor, Department of Urology, University of Miami School of Medicine, and a leading bladder cancer expert. "This is an important new tool for clinicians to fight bladder cancer." In 2001, the FDA cleared UroVysion for use in conjunction with cystoscopy to monitor patients for the recurrence of bladder cancer. Prior to that, monitoring was done primarily by cystoscopy and urine cytology. "The FDA's decision is important because it gives physicians a more powerful diagnostic test than current methods alone to detect one of the most common urological cancers," said Edward Michael, president, Abbott Molecular. "This approval is the most recent example of Abbott's significant strides against cancer through advanced molecular diagnostics and new treatments to help patients live longer, healthier lives." About Fluorescence in situ Hybridization The FISH technology platform is a system in which genes and chromosomes are probed by fluorescent-labeled DNA and then illuminated to allow for clearer identification. It has been shown that by identifying abnormalities in chromosomal DNA, clinicians can effect better treatments. In addition to UroVysion, FISH is utilized in an FDA-approved device, PathVysion(R), to quickly identify which patients with late-stage breast cancer are suitable candidates for Herceptin therapy. Abbott scientists are also exploring FISH's diagnostic capabilities for cervical, esophageal, melanoma and hematological cancers. Product Limitations 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 Bladder Cancer The American Cancer Society estimates that in 2005 there will be about 63,000 new cases of bladder cancer diagnosed in the United States (about 47,000 men and 16,000 women). The chance of a man developing this cancer at any time during his life is about 1 in 30 and for a woman, 1 in 90. In 2005 there will also be about 13,000 deaths from bladder cancer in the United States (about 9,000 men and 4,000 women). Smoking causes nearly half of the deaths from bladder cancer among men (48 percent) and less than a third of bladder cancer deaths in women (28 percent). Over 500,000 people in the United States have a history of this cancer. 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 on a regular basis, including up to four times a year for tumor recurrence. 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 more than 60,000 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/ DATASOURCE: Abbott Laboratories CONTACT: Media, Don Braakman, +1-847-937-1237, or Financial, Christy Wistar, +1-847-938-4475, both of Abbott Laboratories Web site: http://www.cancer.org/ http://www.abbott.com/ Company News On-Call: http://www.prnewswire.com/comp/110328.html

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