Aussie firm begins prostate cancer screening test in US
08.04.2014 / BioSpectrum
Australian biotechnology company Minomic is all set to launch two overseas trials of its MiStat prostate cancer screening test, following an agreement with the prestigious CUSP Group, a Uro-Oncology Trials Management Organisation in the United States.
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 United States. 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 is currently 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 percent specificity; MiStat has a demonstrated specificity of 73 percent.
Principal Investigator for both studies will be Dr. Neal Shore, Medical Director of the Carolina Urologic Research Centre.
He commented, "We look forward to further validating this important technology in these clinical trials and are confident of replicating the extremely positive data recorded in Australia. The CUSP organisation is a peak authority globally on prostate cancer and we are confident their expertise under Dr Shore’s guidance will assist our continued development and global commercialisation of this important technology."