Australian diagnostics company Minomic International Ltd (Minomic) is pleased to announce that their lead product, MiCheck® Prostate, has recorded its initial commercial sales in the US, the world’s largest healthcare market.
Each year, two million American men undergo highly invasive prostate biopsies to diagnose prostate cancer after an elevated Prostate-Specific Antigen (PSA) test result. Prostate biopsies can result in side effects such as bleeding, infections, and difficulty urinating. A significant proportion of these biopsies are unnecessary, as the patient does not have cancer or has a low-grade cancer that requires monitoring rather than intervention.
MiCheck® Prostate is a blood test that can be quickly measured and reported providing an easy-to-understand graphical result. Urologists who have patients with elevated PSA can order the test and receive a report with the percentage risk of aggressive prostate cancer, helping avoid unnecessary biopsies.
The MiCheck® Prostate test is run at Minomic Inc’s CLIA Certified “High Complexity” Laboratory located in Gaithersburg, Maryland. The test has become available following CLIA Laboratory registration and internal validation of MiCheck® Prostate in 2022. The first tests have already been ordered by Las Vegas Urology, a large urology practice based in Nevada.
Importantly, MiCheck® Prostate will be reimbursed through Medicare increasing access for a significant number of men. The most affected cohort are men over the age 65 with the majority (65%) covered by Medicare. Reimbursement also provides a direct pathway to commercial revenues for Minomic.
Dr Brad Walsh, Minomic CEO, said: “We are very excited to have completed the journey, bringing MiCheck® Prostate to commercial reality in the key US market. The high negative predictive value of the test and its superior specificity can better inform urologists and uro-oncologists about the patient’s risk of aggressive prostate cancer.”
Minomic is an Australian cancer-focused diagnostics company that currently offers a next-generation test for prostate cancer, MiCheck® Prostate. The technology works through the implementation of a liquid biopsy, involving a blood test that can differentiate aggressive from non-aggressive tumours. The test utilises standardised methods to detect biomarkers present in the patient’s blood and combines this with clinical factors in a proprietary algorithm that yields a “risk of aggressive prostate cancer” score. It is available in the US through Minomic’s CLIA laboratory as a laboratory developed test.
For more information visit https://www.minomic.com/