FDAnews
www.fdanews.com/articles/67979-fda-approves-urovysion-for-bladder-cancer-diagnosis

FDA Approves UroVysion for Bladder Cancer Diagnosis

January 25, 2005

The FDA 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 both diagnosis and monitoring of bladder cancer recurrence.

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