Cxbladder Clinical Study
In order to determine the clinical validity of this technology it must be evaluated in a clinical study. Such as study is carried out by professional independent analysts and the results are often published in a peer-reviewed scientific publication.
- An international multi-center, prospective cohort study was undertaken with 485 patients presenting with macro haematuria who were suspicious of urinary tract bladder cancer.
- 5 gene qRT-PCR test for the detection of bladder cancer.
- Performance was compared with urine cytology, NMP22 BladderChek (point of care) and NMP2 ELISA tests. The gold standard for comparison was cystoscopy and standard patient care.
The study evaluated the performance of Cxbladder in a target population of patients presenting with visible haematuria who were suspected of having urinary tract bladder cancer. The performance of the test was determined and compared with other available tests (urine cytology and NMP22 tests) using cystoscopy as the gold standard.Results from the study showed that the Cxbladder test:
- Detected 100% of T1, T2, T3, and Tis tumors
- Detected 100% of upper tract tumors
- Detected 97% of high-grade tumors
- Distinguished between low grade Ta tumors and other detected urothelial carcinomas with a sensitivity of 91% and specificity of 90%
- Detected 68% of Ta tumors as compared to cytology at 35%
- Detected urothelial carcinoma (4%) not identified by cystoscopy during the clinical work-up but confirmed by cystoscopy at the 12 month follow-up