Clinical Study 3: Started October 2017, estimated completion Q4 2018
The aim of this study is the transfer of the diagnostic gene signature from tissue to urine, and to prove that Caldera’s diagnostic gene signature performs as an accurate urine test for prostate cancer.
In this study, Caldera will compare vesicle isolation strategies and determine whether any adjustments to the algorithm are required to accommodate urine samples.
By the end of the study, Caldera will have compared the results of the Caldera urine diagnostic test with the gold standard for prostate cancer diagnosis (histology review of biopsy tissue) for at least 300 donors. The final analysis will give the sensitivity and specificity of the diagnostic gene signature on urine.
To provide sufficient samples, Caldera will recruit 500 donors from around New Zealand and Australia who will donate one to two urine samples and their stored FFPE biopsy tissue.