Private Australian biotechnology company Minomic International will launch two overseas trials of its MiStat prostate cancer screening test, following an agreement with CUSP Group, a uro-oncology trials management organization in the U.S.
An initial pilot study to be launched in April will examine 300 patient samples and is designed to verify the accuracy and reliability of the existing MiStat test in differentiating normal, benign and malignant prostate cancer samples.
Preliminary data from this trial will be available by August and will inform a larger pivotal study examining 1200 patient samples. This second trial is expected to begin in September and will source subjects from 12 large urology practices across the U.S. Data from this trial will be available by early 2015.
Both trials will provide critical, late stage evaluation of Minomic's proprietary MiStat technology, which is capable of identifying the presence of a proprietary biomarker. This biomarker is present on the surface of prostate cancer cells. All data to date suggests the MiStat test is almost twice as specific as the Prostate Specific Antigen (PSA) test that currently is the standard test for prostate cancer screening globally. It has been controversial, largely due to the high number of false positive results it generates. Current PSA tests have 40% specificity; MiStat has a demonstrated specificity of 73%.
Data from both CUSP studies will underpin a detailed regulatory submission to the FDA, as well as a commercial data pack for offering to potential partners/licensees.