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FDA approves First Gene-Based Test

UroVysion DNA probe assay for use as an aid in the initial diagnosis of bladder cancer in patients with hematuria (blood in the urine) suspected of having bladder cancer. The test is designed to detect genetic changes in bladder cells in urine specimens using a proprietary technology known as fluorescence in situ hybridization or FISH.

The FISH technology platform is a system in which genes and chromosomes are probed by fluolabeled DNA and then illuminated to allow for clearer identification.

The UroVysion bladder cancer kit is designed to detect aneuploidy for chromosomes3,7,17 and loss of the 9p21 locus via FISH in urine specimens from subjects with transitional cell carcinoma of the bladder.

Abbott Laboratories/2005