FAQ Introduction

Questions and Answers about The UroVysionTM Bladder Cancer Kit (UroVysion Kit), a new Test to Help You Monitor Recurrence of Your Patients' Bladder Cancer

More accurate monitoring means more timely therapy decisions. . .

Cancer does not occur without genetic change . . .

Introduction
Due to the high incidence and prevalence of bladder cancer throughout the world, there has never been a greater need for an unequivocal diagnosis through noninvasive means. This is especially the case with previously diagnosed patients who require on-going monitoring to ensure that disease recurrence is detected as early and as accurately as possible.

Early detection of bladder cancer recurrence is the key to increased survival.

Studies indicate that urine cytology provides such low sensitivity in bladder cancer detection1,2as to be of little diagnostic utility.

New clinical data and recent studies3have demonstrated that Cellular Genomics-based tests using genomic DNA probes and Fluorescence in situ Hybridization (FISH) technology are diagnostically and clinically powerful for the detection of cancer-associated genetic abnormalities and chromosome aberrations in intact nuclei of bladder cells.
Used in conjunction with cystoscopy, genomic DNA probe testing can enhance the detection of bladder cancer recurrence, enabling you to treat your patient's cancer more aggressively as needed.


1Sandberg et al. (1994)
2Schamhart et al. (1998)
3Sokolova et al. (2000); Zhang et al. (1997); Sauter et al. (1997); Meloni et al. (1993);
4Halling et al. (2000)
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.