Minomic launches US pilot trial for MiSat
Minomic International has launched a US pilot trial of its MiSat prostate cancer screening test as part of a planned US FDA submission.
The non-randomised pilot trial will involve the collection of samples from 300 male patients at 11 urology centres.
It will evaluate the accuracy of the existing MiSat ELISA against the standard prostate-specific antigen (PSA) test, evaluating MiSat’s ability to differentiate benign from malignant pathology samples.
The trial’s lead investigator will be Carolina Urologic Research Center medical director CPI Dr Neal Shore. It will be overseen by urology trials consortium The CUSP Group.
Findings from the study will be used to inform a larger, 1200-patient trial in early 2015. They will also be used to inform a regulatory submission to the US FDA.
“We are ensuring a comprehensive data set in order to provide both regulatory authorities as well as potential licensing partners with all of the information required for efficacy evaluation of the MiStat technology,” Minomic CEO Dr Brad Walsh said.
“We would expect data from this US pilot study to further validate the extremely positive evidence we have collected to date, which suggests our technology is almost twice as specific as the PSA screening technology.”
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