DNA Urine Test Diagnoses Bladder Cancer

A DNA-based urine test that detects genetic changes in bladder cells has almost twice the sensitivity of conventional urine cytology tests for the initial diagnosis of bladder cancer in patients with hematuria (blood in urine).

UroVysion, which was developed by Abbott Molecular (Des Plaines, IL, USA), 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 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 and has been approved by the U.S. Food and Drug Association (FDA).

According to the authors of a study published in the July 2006 edition of the Journal of Urology, hematuria is the symptom most commonly associated with bladder cancer. But because bladder cancer accounts for only about 10% of patients with hematuria, a delay between the first symptoms and diagnosis is common and adversely affects patient outcomes.

The prospective, blinded study involved 497 eligible patients with an average age of 63 from 23 clinical sites throughout the United States and Canada. The results showed that UroVysion detected 69% of bladder tumors, while cytology detected 38%. When low grade, low stage (i.e., Ta grade 1) tumors were excluded, UroVysion detected 83% of the cases, while cytology detected only 50%. The "negative predictive value” or probability that negative UroVysion results were not associated with bladder cancer in this group was 98.5%.

"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.”



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