UroVysion Bladder Cancer Test

The UroVysion Bladder Cancer Kit (UroVysion Kit) uses fluorescence in situ hybridization (FISH) assays on voided urine specimens fixed on microscope slides. The UroVysion Kit consists of a four-color, four-probe mixture of DNA probe sequences homologous to specific regions on chromosomes 3, 7, 9, and 17. The UroVysion probe mixture consists of Chromosome Enumeration Probe (CEP) CEP 3 SpectrumRed, CEP 7 SpectrumGreen, CEP 17 SpectrumAqua and Locus Specific Identifier (LSI 9p21 SpectrumGold. The probes are pre-mixed and pre-denatured in hybridization buffer for ease of use. Unlabeled blocking DNA is also included with the probes to suppress sequences contained within the target loci that are common to other chromosomes. When hybridized and visualized, these probes provide information on chromosome copy number for chromosome ploidy enumeration.

This UroVysion Kit is designed for the detection and quantification of chromosomes 3, 7, and 17, and the 9p21 locus in human urine specimens by FISH, and is used in conjunction with cystoscopy.

Terms:
Ploidy: A muliple of the basic number of chromosomes in a cell.

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.