ABBOTT PARK, IL (Jan. 25, 2005) — The U.S. Food and Drug Administration has approved Abbott’s UroVysion 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 bothdiagnosis 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 cliniciansto 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.”
