- 58% Fewer patients proceed to Biopsy.
- US Rollout well advanced.
May 17, 2018: [Sydney] 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 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,