The trial was a prospective, non-randomized case-control study, with a primary endpoint of detecting prostate cancer vs no cancer and a secondary endpoint, differentiating between aggressive and non-aggressive cancer. Twelve US research centers located across the US, all part of the CUSP Uro-Oncology Network, provided samples from 384 patients.
Both endpoints were met, demonstrating competitive sensitivity and specificity in both the identification of prostate cancer and differentiating aggressive from non-aggressive cancer.
Minomic’s CEO, Dr. Brad Walsh, noted “We are very pleased with these results. MiCheck® has continued to show significant utility in assisting clinicians to decide whether patients require biopsy. This has major health economic benefits, reducing the need for biopsy, a costly and invasive procedure, as well as obvious patient benefits.”
The results from the trial also provide a strong foundation for the US rollout of MiCheck® as a Laboratory Developed Test (LDT). Minomic is well advanced in discussions with a number of potential laboratory partners with a view to making the test available as soon as possible.
Dr. Neal Shore, Director of Carolina Urologic Research Center, who is the trial’s Principal Investigator, commented “New biomarker tests such as MiCheck® will assist clinicians in selecting and optimizing a more precise clinical pathway for both the diagnosis and treatment of prostate cancer.”
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 the MiCheck® test 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 MIL-38 antibody for prostate cancer.