Project description and overview:

An estimated 17,000 cases of prostate cancer are diagnosed each year in Australia. Prostate cancer mainly affects males aged 50+. The two most common prostate cancer tests are the prostate specific antigen (PSA) blood test and the digital rectal examination (DRE). The PSA and other prostate tests suffer to differing degrees from the following; Poor specificity (false positives), poor sensitivity (false negatives) and the inability to diagnose cancer aggressiveness.

This results in over-diagnosis, needless patient anxiety, and unnecessary prostate biopsies that are a cost burden to public health. Urologists want a simple preferably blood-based test with enhanced specificity to reduce patient anxiety, unnecessary biopsies, and identify only patients needing urgent biopsy.

Minomic has developed an in-vitro diagnostic (IVD) test called MiCheck® Prostate (MiCheck®) specifically designed to indicate the percentage risk of aggressive prostate cancer and enable a consulting physician to determine the need for biopsy. MiCheck® is a patented, clinically proven algorithm that measures a ratio of 3 protein analytes from a standard patient blood test combined with a clinical factor to determine a patient’s risk of having aggressive prostate cancer that needs an urgent confirmatory biopsy and possible rapid treatment.

It is designed for use initially as an adjunct to an abnormal PSA result prior to prostate biopsy. Pathology labs processing blood samples will test the 3 MiCheck® blood markers. The result plus the clinical factor is sent to the MiCheck® Web Portal where the MiCheck® cloud-based algorithm analyses the result and returns a completed report to the pathology lab for onward transmission to the clinician.

This Project will bring to market Minomic’s MiCheck® Prostate test, an algorithm driven, in-vitro diagnostic (IVD) test specifically designed to indicate the risk of aggressive prostate cancer and enable a consulting clinician to determine the need for a biopsy.

The Project will fund validation tests in Australia, develop laboratory interfaces for MiCheck® Prostate’s web portal and cloud-based testing algorithm; develop logistics and reporting environment and market education; and fund market pricing studies and materials to engage clinicians in Australia, before an initial rollout to Australian Eastern seaboard urologists.