UroVysion Test

UroVysion (Abbott Laboratories Inc., Downers Grove, IL, US) is a multi-probe fluorescence in situ hybridisation (FISH) technique to detect aneuploidy for chromosomes 3, 7, 17 and loss (deletion) of the ^9p21 locus via fluorescence in situ hybridisation (FISH) in exfoliated bladder tumour cells. Table 6 lists studies of the UroVysion test published by various groups.^56–60 Overall, UroVysion improves the sensitivity rates reported for urine cytology in detection of all tumour stages and grades with a similar specificity. Grade 1 and 2 bladder cancer was detected in 36% to 83% and in 76% to 83%, respectively. Placer et al.57 reported a lower sensitivity for cytology with 64% overall, 25% for grade 1, 67% for grade 2 and 95% for grade 3 tumours compared with FISH – 80%, 53%, 83% and 100%. Skacel et al.56 tested urine samples from patients with suspicious, atypical and negative cytology compared with biopsy data. The sensitivity was 100%, 89% and 60%. Nine patients with atypical cytology had positive FISH in the setting of a negative concurrent bladder biopsy. All had biopsy proven carcinoma, no later than 15 months following the date when the sample tested by FISH was obtained. The results achieved with UroVysion emphasise an important role of this assay in the management of bladder cancer. UroVysion provides high sensitivity and specificity to detect transitional cell carcinoma in cytologically equivocal and negative urine samples. UroVysion appears to be a promising tumour marker for the early detection of recurrent bladder cancer and may be useful for screening persons at risk for bladder cancer.

Conclusions

Recent developments in the field of bladder tumour marker tests are either qualitative or quantitative measurements of urinary proteins or detection of antigens or chromosomal aberrations in urine cytology samples. These tumour marker tests demonstrated improved sensitivity for the diagnosis of urothelial cancer compared with urine cytology. Overall, the mean sensitivity and mean specificity was 64% to 80% and 71% to 95% and the mean PPVs and NPVs to detect malignancy were 49% to 84% and 79% to 95% (see Table 7). Sensitivity for Ta grade 1 bladder cancer was poor in tests detecting proteins released into urine by tumour cells. BTA TRAK, BTA stat, NMP22 and NMP22 BladderChek assays are limited by false-positive results in patients with benign urological disease such as haematuria, urocystitis, renal calculi, or UTIs, as well as in patients with incorporated catheters or intravesical manipulation in the last weeks. Due to low specificity BTA TRAK, BTA stat, NMP22 and NMP22 BladderChek should not be used without first ruling out benign or malignant genitourinary disease other than bladder cancer. Insufficient sensitivity along with limited specificity does not allow replacing cystoscopy in diagnosis of bladder cancer or treatment decisions based on a positive test result. With the exception of UroVysion, achieving 80% sensitivity and 94% specificity, none of these non-invasive tests revealed a high sensitivity and specificity at the same time, which would be a main criterion of an ideal tumour marker. Furthermore, UroVysion is not limited by exclusion criteria.