- WebCafé home
- Newly Diagnosed
- Treatment Options
- Non-Invasive blc
- Invasive bladder cancer
- Upper tract TCC
- Metastatic cancer
- Clinical trials
- Survival Guides
- Resources USA & Canada
- Resources Europe
- Clinical trials
- Alternative medicine
- Financial help
- About Us
|The Vysis® UroVysion Bladder Cancer Recurrence Kit|
Cellular Genomics is a technology platform that uses known DNA sequence information to design products that can detect genetic changes associated with disease. This platform is especially useful for the detection of cancer since cancer does not occur without genetic change. Some examples of the genetic changes associated with cancer include chromosome aneuploidy, chromosome translocations/rearrangements, deletions, or amplifications. Aneuploidy - a condition where the number of chromosomes in a cell differs from the normal diploid number (two copies of each chromosome, 46 total) by loss or duplication of chromosomes.
Translocation - a condition where part of a chromosome is detached by breakage and then becomes attached to some other chromosome.
Deletion - a condition where a sequence of DNA along a chromosome is removed and the regions on either side become joined together.
Amplification -- refers to the production of additional copies of a chromosomal sequence, which may then be present on the same or a different chromosome.
Direct examination of the genome (all of the DNA within a cell) is a sensitive and powerful means to detect cancer with minimal subjectivity. Vysis' Cellular Genomics products, including the VysisÒ UroVysion Bladder Cancer Recurrence Kit, use this approach for disease management.
A typical FISH procedure involves three key steps: specimen preparation, hybridization, and viewing.
Goal of the Product
Clinical Trial Data
Patients for the clinical trials were enrolled in 21 urology centers throughout the US and Canada. A total of 275 patients were examined, including 59 normal volunteers. Within unique patients, the test provided 94.5% specificity. Within the 59 normal volunteers, the test was 100% specific, indicating that the chance of a false positive with this test is very low. Sensitivity of the test was compared to a gold standard of cystoscopy and histology. Table 1 below summarizes the comparison data:
Table 1. Comparison of Vysis UroVysion vs. Cystoscopy/Histology for Detection of Bladder Cancer Recurrence by Stage and Grade*.
Agreement of (+) Results (%)
*Biopsy was not performed in 11 cases. In addition, no stage was assigned in 3 cases and no grade in 2 cases.
The Vysis UroVysion Kit detects all stages and grades of bladder cancer but is highly sensitive for the more dangerous higher grade and stage types.
While cystoscopy/histology was the gold standard for comparison in these studies, the sensitivity and specificity of BTAstatä and standard cytology was also determined on the same samples. Sensitivity of BTAstatä was 30%, 83%, 83%, 67%, and 43%, respectively for TaG1, TaG2,3, T1, T2, and Tis (tumor in situ or carcinoma in situ). Sensitivity of cytology was 20%, 30%, 67%, 33%, and 33%, respectively, for TaG1, TaG2,3, T1, T2, and Tis. Specificity of BTAstatä was 18%, 44%, and 41%, respectively, for grade 1, 2, and 3 bladder cancer. Specificity of cytology was 18%, 44%, and 41%, respectively, for grade 1, 2, and 3 bladder cancer.
The Vysis UroVysion Kit performed extremely well in patients receiving BCG intravesical treatment. Test result agreement with gold standard cystoscopy/histology was 92%, indicating that the test results are unaffected by BCG-treatment, infection, or other genitourinary diseases that cause inflammation of the bladder lining.
Halling KC, King W, Sokolova IA, Meyer RG, Burkhardt HM, Halling AC, Cheville JC, Sebo TJ, Ramakumar S, Stewart CS, Pankratz S, O'Kane DJ, Seeling SA, Lieber MA, Jenkins RB (2000) A comparison of cytology and fluorescence in situ hybridization for the detection of urothelial carcinoma. Journal of Urology 164(5): 1768-1775
Sokolova IA, Halling KC, Jenkins RB, Burkhardt HM, Meyer RG, Seelig SA, King W (2000) The development of a multitarget, multicolor fluorescent in situ hybridization assay for the detection of urothelial carcinoma in urine. Journal of Molecular Diagnostics 2(3): 116-123
This page contributed to WebCafe by
|Last Updated ( Friday, 14 November 2008 )|