The UroVysion Bladder Cancer Recurrence Kit (UroVysion Kit), recently cleared by the FDA, 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 subjects with transitional cell carcinoma of the bladder.
Results are intended for use as a non-invasive method for monitoring for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer.
The test is based on the detection of genetic changes in the bladder cells using this company’s proprietary fluorescence DNA probe technology.
The kit can be used with the Vysis VP 2000 Processor for specimen pretreatment and the HYBrite Denaturation/Hybridization unit for modular automation.
It is increasingly clear that abnormalities in numbers of chromosomes and genes are a significant early event in the cancer process. The UroVysion test detects a specific set of chromosome abnormalities, which is indicative of a recurrence of bladder cancer.
After initial diagnosis and treatment, patients are routinely monitored every three months for the first two years then twice a year for three or more years. Up to 50 percent of patients will have recurrence of bladder cancer within five years. Earlier detection of this recurrence by routine monitoring can mean the difference between sparing the patient’s bladder, and even the patient’s life in many instances.
Vysis Inc.
www.vysis.com
Keyword: bladder cancer, test, DNA
