Background
Product development
The UroVysionTM Bladder Cancer Kit (UroVysion Kit) was developed by an iterative process that methodically tested a set of DNA probes on bladder cells obtained from urine samples of patients with and without bladder cancer. The set of probes was selected for testing based on reports in the scientific literature that associated these changes in DNA (chromosome copy number changes or deletion of the locus) with bladder cancer. For example, the 9p21 region is important because it contains a proposed tumor suppressor gene, p16. Deletion of p16 is one of the most common alterations in urothelial carcinoma (bladder cancer)18.
The UroVysionTM Bladder Cancer Kit (UroVysion Kit) was developed by an iterative process that methodically tested a set of DNA probes on bladder cells obtained from urine samples of patients with and without bladder cancer. The set of probes was selected for testing based on reports in the scientific literature that associated these changes in DNA (chromosome copy number changes or deletion of the locus) with bladder cancer. For example, the 9p21 region is important because it contains a proposed tumor suppressor gene, p16. Deletion of p16 is one of the most common alterations in urothelial carcinoma (bladder cancer)18.
At the end of the study, a set of four DNA probes was selected that provided the greatest sensitivity for urothelial carcinoma detection18
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FDA Clearance
On August 3, 2001, the US FDA cleared for marketing the UroVysionTM Bladder Cancer Kit (UroVysion Kit) for monitoring the recurrence of bladder cancer.
The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
