Trial Information

Concordance Study for Detection of Chromosomal Aberrations Using FISH in Urine Samples Sections

The FISH test detect chromosomal aberrations in urine specimens from persons with
hematuria suspected of having bladder cancerous using the UroVysion® Bladder Cancer Kit
(UroVysion Kit) which is FDA approved. This kit is designed to detect aneuploidy for
chromosomes 3, 7, 17, and loss of the 9p21 locus. 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.