Minomic has initiated a prospective US trial of its MiCheck prostate cancer screening test.
The company said the trial will seek to verify MiCheck’s accuracy and reliability in detecting prostate cancer, especially for identifying patients with clinically significant cancer. The 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, will oversee the sample collection from 10 or more urology practices in the US.
The trial’s Principal Investigator, Dr Neal Shore MD, medical director, CPI at the Carolina Urologic Research Center, has conducted more than 300 clinical trials and is an internationally recognised prostate cancer researcher and educator.
According to Dr Shore, “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,” said Minomic CEO, Dr Brad Walsh. “The data will also be used to support our overall commercialization strategy.”
He continued, “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.
“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.