Minomic plans US trials for prostate cancer test
Sydney’s Minomic International has arranged to hold two US trials of its prostate cancer screening test MiSat in collaboration with uro-oncology trials management organisation CUSP Group.
The companies are planning a pilot trial in April that will examine 300 patient samples in order to test the accuracy and reliability of the test in differentiating normal, benign and malignant prostate cancer samples.
Results from this study will inform the design of a larger second trial, which will examine 1200 patient samples. This trial will source samples from 12 US urology practices.
The second trial is expected to begin in September, and data should be available by early 2015. Data from both studies will be used to support a regulatory submission to the US FDA and to help promote the test to potential partners or licensees.
The principal investigator for both trials will be Dr Neal Shore, medical director of the Carolina Urologic Research Center.
The MiSat test is designed to detect the presence of a proprietary biomarker present on the surface of prostate cancer cells.
Previous trials suggest that the test may be almost twice as specific as the standard Prostate Specific Antigen (PSA) test, which is known for generating a high number of false positives.
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