SYDNEY--(BUSINESS WIRE)--Minomic International Ltd, an Australian immuno-oncology company, has initiated a prospective US trial of its MiCheck® prostate cancer screening test. This important trial will further verify MiCheck’s accuracy and reliability in detecting prostate cancer, especially for identifying patients with clinically significant cancer. MiCheck® technology is a blood based multi-index analyte assay capable of identifying the presence of prostate cancer.
The trial will collect blood samples from 50 healthy control patients and 300 patients planning to undergo prostate biopsy. The Uro-oncology trials group, CUSP LLC, will oversee the sample collection from 10 or more urology practices within the US.
The trial’s Principal Investigator, Neal D. Shore MD FACS, Medical Director, CPI at the Carolina Urologic Research Center, has conducted more than 300 clinical trials and is an internationally recognized prostate cancer researcher and educator.
Dr Shore commented, “Advancing biomarker technology to assist both patients and physicians in order to optimize a shared-decision making regarding a choice to have a prostate biopsy, or not, is both clinically important for patient outcomes and also for enhancing value based healthcare goals. Thus we are looking forward to this important trial which will augment our earlier findings presented at AUA, New Orleans, 2015.”
“Data from the study will support introduction of the MiCheck® test in the United States as a Laboratory Developed Test via Clinical Laboratory Improvements Amendment (CLIA) Act certified laboratories,” Minomic Chief Executive Officer, Dr Brad Walsh, explained. “The data will also be used to support our overall commercialization strategy.”
“This trial with CUSP Group, LLC/CUSP Clinical Research Consortium will also provide comprehensive data for regulatory authorities and potential licensing partners to evaluate the efficacy of the MiCheck® technology,” said Dr Walsh.
“We expect data from this US study to further validate the extremely positive evidence we have collected to date, which suggests our technology is almost twice as specific as PSA screening technology,” he added.
Minomic International Ltd is an Australian immuno-oncology company specialising in therapeutics and diagnostics for solid tumors, including prostate, bladder and pancreas. Minomic has developed an in vitro diagnostic test called MiCheck® for the detection of prostate cancer. Minomic is preparing to globally launch the MiCheck® test, which has been shown to be more than twice as specific as the existing gold standard Prostate Specific Antigen (PSA) screening technology. This means that MiCheck® delivers only 1.5 false positives from every ten samples, compared to 6 false positive results in every 10 samples using the standard PSA test. The MiCheck® technology uses Glypican-1, a recently identified biomarker and other biomarkers never previously used in prostate cancer diagnosis. Minomic is interested in partnerships or collaborations with larger pharmaceutical/diagnostic global partners able to produce, register and distribute the MiCheck® test and collaborate through registration and commercialization of future diagnostic imaging and therapeutic applications of the MiltuximabTM antibody for prostate cancer.