Australian immuno-oncology company Minomic has announced the completion of the prospective clinical trial of its novel prostate cancer diagnostic test, MiCheck.
According to the company, 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%," it said.
The trial was a prospective, non-randomised case-control study, with a primary endpoint of detecting prostate cancer versus no cancer and a secondary endpoint, differentiating between aggressive and non-aggressive cancer. Twelve US research centres located across the US, all part of the CUSP Uro-Oncology Network, provided samples from 384 patients.
Both endpoints were met, said Minomic in a statement, "demonstrating competitive sensitivity and specificity in both the identification of prostate cancer and differentiating aggressive from non-aggressive cancer."
“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,” said CEO Dr Brad Walsh
Dr Neal Shore, the trial's principal investigator and director of Carolina Urologic Research Center, said" “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.”