Abbott's UroVysion more effective in diagnosing bladder cancer, study says

By Elaine Rigoli

Tampa, Fla., July 20 - Abbott said Thursday that a study published in the July edition of Journal of Urology shows that UroVysion, a DNA-based urine test that detects genetic changes in bladder cells, has almost twice the sensitivity of conventional urine cytology tests, the current gold standard.

The company said this exam is for the initial diagnosis of bladder cancer in patients with hematuria (blood in urine) suspected of having bladder cancer.

According to the authors of the study, hematuria is the symptom most commonly associated with bladder cancer.

However, because bladder cancer only accounts for about 10% 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, according to a news release.

The results showed that UroVysion detected 69% of bladder tumors, while cytology detected 38%.

When low-grade, low-stage tumors were excluded, UroVysion detected 83% of the cases, while cytology detected only 50%, the release said.

Further, the "negative predictive value" or probability that negative UroVysion results were not associated with bladder cancer in this group was 98.5%.

Abbott is a global health care company based in Abbott Park, Ill.

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