Australian biomarker discovery company Minomic International Ltd has announced it will launch a U.S. trial of its MiStat™ prostate cancer screening test, with aims of achieving U.S. Food and Drug Administration (FDA) regulatory approval upon completion.
MiStat™ technology is an early detection screening assay that can identify the presence of a specific and proprietary biomarker, the MIL-38 antigen, that is present on the surface of prostate cancer cells.
Early clinical trials preformed on 125 Australian patients, have successfully shown that MiStat has enough sensitivity and specificity for discriminating prostate cancer patients from those with benign prostatic hyperplasia or no disease.
Now, researchers at 11 leading urology centers in the United States will gather samples from 300 male patients over age 50 in a nonrandomized pilot study designed to assess the accuracy, reliability and efficacy of the test in distinguishing normal, benign and malignant prostate cancer.
Furthermore, the clinical study will compare the MiStat™ ELISA to the Prostate Specific Antigen (PSA) test, to determine the efficiency of the new kit over this commonly used diagnostic technique.
The trial, conducted by Dr. Neal Shore MD FACS, Medical Director, CPI, Carolina Urologic Research Centre, will inform a larger pivotal study examining 1200 patients that will begin in 2015, comprising subjects from large urology practices throughout the United States.
Following the successful completion of the trial, a meeting request will be submitted to the FDA, with the aim to make MiStat™ ELISA commercially available in 2015.
“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. 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,” Dr. Brad Walsh, Minomic Chief Executive Officer, said in a PR Newswire press release.