ABOUT UROVYSION® BLADDER CANCER KIT
UroVysion, the advanced molecular diagnostics generation of bladder cancer detection, aids—in conjunction with and not in lieu of standard diagnostic procedures—in the initial diagnosis of bladder carcinoma in patients with hematuria, and also in the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
In 2001, UroVysion became the first FDA-approved urine-based molecular test for bladder cancer. UroVysion has these characteristics:
- UroVysion’s sensitivity is better than the sensitivity of cytology for all stages and grades.1
- UroVysion’s most pronounced benefit is for “serious” recurrences (CIS, high-grade or invasive).1
- Detects chromosomal abnormalities associated with the development and progression of bladder cancer
- Offers the best available combination of sensitivity and specificity1
- Detects bladder cancer recurrence up to 6 months sooner than current diagnostic methods1
UroVysion, as run by PersonalizeDx, adheres to the FDA-approved labeling for UroVysion, without modifications in procedures that potentially may alter the performance of the assay. Studies show that, in patients previously diagnosed with bladder cancer, UroVysion (in combination with cystoscopy) demonstrated a 97% sensitivity.1 The overall specificity of UroVysion was 93%, as indicated in the FDA-approved labeling for UroVysion.
UroVysion provides important information based on the early detection of subtle changes in chromosomes found in patients' genes. This information may allow for the earlier diagnosis of bladder cancer and the monitoring for disease recurrence.
The UroVysion Bladder Cancer Kit (UroVysion Kit) is FDA-approved and 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 the initial diagnosis of bladder carcinoma in patients with hematuria and the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
UroVysion uses four DNA probes, each labeled with a different color fluorescent tag, that bind to specific gene sequences on human chromosomes. These probes reveal genetic abnormalities that may be associated with cancer.
UroVysion is used to monitor for recurrence of bladder cancer. An anticipatory positive UroVysion result can be predictive of bladder cancer recurrence. An anticipatory positive is defined as a positive/abnormal result, despite an initial negative cystoscopy/histology, where a tumor is subsequently identified by cystoscopy/histology.
See the UroVysion package insert for more information about the positive predictive value (PPV) and negative predictive value (NPV) of UroVysion.
1 Halling KC, King W, Sokolova IA, et al. A comparison of cytology and fluorescencein situ hybridization for the detection of urothelial carcinoma. J Urol, 2000; 164; 1768-1775.