The gold standard for detecting
bladder cancer is cystoscopy which identifies nearly all papillary and sessile lesions. However, it is an invasive procedure causing some discomfort for patients. Urine cytology is the standard non-invasive marker with very high specificity, but unfavourable poor sensitivity for Ta, G1, and T1
bladder tumors. To improve early detection of
bladder cancer as well as to monitor treatment response and
tumor recurrence,
bladder tumor markers are eligible. An ideal
bladder cancer test would have the potential to replace or delay cystoscopy in the follow-up of
bladder cancer patients. In recent years, the FDA approved non-invasive
tumor marker tests ImmunoCyt / uCyt+, BTA TRAK, BTA stat,
NMP22,
NMP22 BladderChek, and UroVysion have been investigated. The tests demonstrated higher sensitivity for diagnosis of
bladder cancer compared to urine cytology. Overall, the mean sensitivity and mean specificity was 64-80% and 71-95% and the mean positive and negative predictive values to detect
malignancy were 49-84% and 79-95%, respectively. BTA TRAK, BTA stat,
NMP22, and
NMP22 BladderChek assays are limited by false-positive results in patients with benign
urological diseases such as
hematuria, urocystitis,
renal calculi or
urinary tract infections. 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. 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 is a main demand to be made on an ideal
tumor marker. 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.