Results

 

Interpretation of results from the UroVysion Kit is simple and straightforward. To start, a patient specimen slide is first scanned for cells that have abnormal-appearing nuclei (large, irregular shape, etc.) since these are likely candidates to have experienced some sort of cancer-associated genetic change. The DNA probe profile (the number of probe signals of each color) is then recorded to determine if there is aneusomy of chromosomes 3, 7, or 17, or deletion of the 9p21 locus. If no nuclei appear abnormal, the probe signal pattern of the remaining cells are reviewed to identify cancer-associated changes in the absence of changes in cell morphology (shape of the cell). The ability to detect likely cancer cells that do not yet appear abnormal is a distinct advantage of the UroVysion Kit over traditional cytology.

Sample images

The following examples of patient specimens demonstrate both the clinical utility of the UroVysion Kit as well as its simplicity of interpretation.

Normal result observed in an interphase cell obtained from a sample after the UroVysionTM Bladder Cancer Kit (UroVysion Kit) hybridization. Each probe signal; CEP 3 (red), CEP 7 (green), CEP 17 (aqua) and LSI p16 (gold) is present in two copies.
Abnormal result observed in an aneusomic interphase cell obtained from a sample showing two copies of chromosome 3 (red), four copies of chromosome 7 (green), five copies of chromosome 17 (aqua) and one copy of p16 gene (gold) after the UroVysionTM Bladder Cancer Kit (UroVysion Kit) hybridization.
Abnormal result observed in an aneusomic interphase cell obtained from a sample showing three copies of chromosomes 3 (red), 7 (green) and 17 (aqua) and absence of both p16 genes indicated by absence of gold signals after the UroVysionTM Bladder Cancer Kit (UroVysion Kit) hybridization.
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.