Minomic International, an Australian immuno-oncology company, has initiated a prospective trial of its MiCheck Prostate Cancer Screening Test in the United States to further verify the technology’s accuracy and reliability in detecting prostate cancer.
MiCheck works by analyzing a patient’s blood sample to detect the presence of prostate cancer. For this trial, 50 healthy control patients and 300 patients planning to undergo prostate biopsy will be analyzed with MiCheck.
An uro-oncology trials group, CUSP, will oversee the sample collection from 10 or more urology practices in the United States.
“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,” Neal D. Shore, MD, FACS, medical director at the Carolina Urologic Research Center, said in a press release. Shore is conducting the trial, after leading more than 300 clinical studies related to prostate cancer.
“Thus we are looking forward to this important trial which will augment our earlier findings presented at AUA, New Orleans, 2015,” he added, referring to a previous American Urological Association annual meeting.
The MiCheck test works by screening a biomarker, known as the MIL-38 antigen, which is found at the surface of prostate cancer cells. In prior trials, the test demonstrated a specificity of 85 percent, which contrasts with the 40 percent specificity of the existing PSA screening technology. In other words, while PSA testing delivers six false positive test results in every 10 samples, MiCheck delivers only 1.5 false positives.
“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 laboratorie,” said Brad Walsh, Minomic’s CEO. “The data will also be used to support our overall commercialization strategy.”
“This trial with CUSP Group/CUSP Clinical Research Consortium will also provide comprehensive data for regulatory authorities and potential licensing partners to evaluate the efficacy of the MiCheck technology,” Walsh said. “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.”
In July, another company, Neolys Diagnostics, announced the development of a different blood test, designed to measure patients’ sensitivity to radiation before they receive radiation therapy, a common prostate cancer treatment. The test was created to help doctors choose a radiation level that a patient’s healthy tissue can withstand with as little damage as possible.
The rise of blood tests in prostate cancer care, whether they’re designed for diagnosis or for helping the doctors decide which treatment approach is best suited for each patient, could help lower the severity or frequency of the known side effects of prostate cancer treatment, which are life-altering for men.