The sensitivity of the UroVysion DNA urinary test is too low to be considered an alternative to cystoscopy in the follow-up of patients with superficial bladder cancer, according to researchers in Sweden. 


The test, however, is valuable for detecting carcinoma in situ (CIS) in the bladder, the investigators concluded. It should be considered in patients with a history of high-grade urothelial cancer, patients with equivocal cystoscopic findings, and patients with inconclusive or atypical urine cytology, they stated.

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The team, led by Sigurdur Gudjonsson, MD, of Lund University Hospital, analyzed follow-up visits of 175 patients, of whom 48 (27%) had suspected recurrence of bladder cancer on cystoscopy, whereas only 15 patients (9%) had a positive UroVysion test.


Analysis of tissue samples confirmed recurrence in 27 patients, of whom 17 had low-grade tumors (pTaG1-G2) and 10 had high-grade tumors (CIS, pTaG3, pT1G3). UroVysion identified only 30% of all pathologically verified recurrences, but the sensitivity of the test for detecting high-grade tumors was 70%, the researchers reported.


UroVysion and cytology were unable to detect T1 tumors in three patients, but UroVysion detected all six CIS cases and was positive in two other patients who developed CIS later (within one year of study enrollment). Cytology was positive in only four of these eight cases.