Clinical Trials

 

Cancer detection products are typically evaluated in terms of their sensitivity and specificity during clinical trials. Sensitivity is a statistical measure of the accuracy of a test, i.e. how likely a test is to label as positive those who have a disease or condition. Specificity measures the product's ability to detect true positives; in this case, this means true chromosomal abnormalities.

Patients for UroVysionTM pivotal clinical trials were enrolled in 21 urology centers throughout the US and Canada. A total of 275 patients were examined, including 59 normal volunteers. Within unique patients, the test provided 94.5% specificity. Within the 59 normal volunteers, the test was 100% specific, indicating that the chance of a false positive with this test is very low. Sensitivity of the test was compared to a gold standard of cystoscopy and histology. Table 1 below summarizes the comparison data:

Table 1. Comparison of UroVysion vs. Cystoscopy/Histology for Detection of Bladder Cancer Recurrence by Stage and Grade*.
Agreement of (+) Results (%)
Stage
Ta, Grade 136/48 (75.0%)
Ta, Grade 2-311/20 (55.0%)
T110/12 (83.3%)
T23/3 (100%)
Tis7/7 (100%)
Grade
All36/49 (73.5%)
112/22 (54.5%)
27/9 (77.8%)
317/18 (94.4%)
*Biopsy was not performed in 11 cases. In addition, no stage was assigned in 3 cases and no grade in 2 cases.

The UroVysionTM Bladder Cancer Kit (UroVysion Kit) detects all stages and grades of bladder cancer.  It is highly sensitive for more dangerous higher grade and stage tumors.

While cystoscopy/histology was the gold standard for comparison in these studies, the sensitivity and specificity of BTAstatTM and standard cytology was also determined on the same samples. Sensitivity of BTAstatTM was 30%, 83%, 83%, 67%, and 43%, respectively for TaG1, TaG2,3, T1, T2, and Tis. Sensitivity of cytology was 20%, 30%, 67%, 33%, and 33%, respectively, for TaG1, TaG2,3, T1, T2, and Tis. Specificity of BTAstatTM was 18%, 44%, and 41%, respectively, for grade 1, 2, and 3 bladder cancer. Specificity of cytology was 18%, 44%, and 41%, respectively, for grade 1, 2, and 3 bladder cancer.

The UroVysion Kit performed extremely well in patients receiving BCG intravesical treatment. Test result agreement with gold standard cystoscopy/histology was 92%, indicating that the test results are unaffected by BCG-treatment.

The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.