Australian immuno-oncology company Minomic International Ltd is pleased to announce the completion of its prospective clinical trial of the company’s novel prostate cancer diagnostic test, MiCheck®. The trial demonstrated utility identifying patients with elevated PSA who did not require a biopsy. The prospective trial demonstrated that using MiCheck® could reduce the number of patients (with a clinically elevated PSA) proceeding to biopsy by up to 58%.
The company reports 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.”