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.
The clinical study for Cxbladder entailed a multicentre, prospective cohort study of patients with a recent history of gross haematuria, who were undergoing investigation of haematuria (by cystoscopy) for possible urological cancer1.
Eligible consenting patients provided a freshly voided mid-stream urine sample prior to cystoscopy, for Cxbladder, the NMP22 tests and urine cytology analysis. Comparator tests; NMP22 ELISA and urine cytology were analysed independently at Southern Community Laboratories, Dunedin.
The NMP22 BladderChek test was conducted at each clinical site. The presence of urinary tract TCC was determined by biopsy and histopathological examination within a 3 month period following study registration.
Patients who are not diagnosed with TCC at three months, but positive for Cxbladder, were followed up at one year to determine disease and survival status.