TEST:

MiCheck® Prostate

"Minomic...announce the publication of the company’s latest research paper supporting the utilisation of MiCheck Prostate as an aid to diagnosing clinically significant prostate cancer."

"Minomic International Ltd...announce that the company’s ground-breaking test for prostate cancer, MiCheck Prostate, has received its first reimbursement in the United States from the Centres for Medicare and Medicaid Services (CMS)."

"The MiCheck® Prostate test identifies clinically significant prostate cancer with high sensitivity and negative predictive value (NPV). It can be performed in a clinical laboratory using a Roche Cobas clinical chemistry analyzer. The MiCheck® Prostate test could assist in reducing unnecessary prostate biopsies with a marginal number of patients experiencing a delayed diagnosis."

"We are proud to be presenting at the 23rd Asia-Pacific Prostate Cancer Conference, one of the largest comprehensive prostate cancer meetings in the world, that is being held between 18 – 20 August 2023 in Cairns...Minomic CEO, Dr Brad Walsh will present a poster 'Performance of MiCheck Prostate in Patients with a Prior Prostate Biopsy'. The performance data will also be presented in a rapid-fire talk on Saturday 19 August at 1pm in the trade display area."

The current study demonstrates MiCheck Prostate has high sensitivity for detection of significant prostate cancer in an Australian population. MiCheck Prostate has high sensitivity in both the pre-MRI and post-MRI settings as well as in the PIRADs 1-3 subgroup. MiCheck Prostate provides additional information to urologists and patients in the decision to proceed to prostate biopsy with patients suspected of having prostate cancer.

"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...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."

"Minomic International Ltd has taken a step forward to bring the MiCheck® Prostate test to Australians...With testing available now at selected Sonic Healthcare Australia Pathology laboratories, Minomic can offer MiCheck® Prostate to many more Australian men."

"Minomic CEO Dr Brad Walsh and US Commercialisation Lead Megan Henken presented at its US lab partner 20/20 GeneSystems’ ribbon cutting event in Rockville, Maryland last week to celebrate the commencement of CLIAx’s operations...Minomic signed an agreement with 20/20 GeneSystems’ CLIAx team to provide lab services essential to bringing to market its MiCheck® Prostate test that is designed to detect aggressive prostate cancer."

"Minomic International Limited is pleased to announce that its wholly owned subsidiary, Minomic Inc., has been granted a Clinical Laboratory Improvement Amendments (CLIA) certification, allowing its lab to officially open for business, in Gaithersburg, MD...The CLIA program regulates laboratories that perform testing on patient specimens in order to ensure accurate and reliable test results. CLIA enables the release of test results following the laboratory demonstrating certain quality assurance characteristics relating to analytical validity for the use of that test system in the laboratory’s own environment."

The MiCheck Prostate test shows high sensitivity, specificity and NPV for the detection of aggressive prostate cancer. It uses analytes widely available on standard clinical chemistry analysers such as Abbott Architect and Roche Cobas, hence is simple to deploy in the laboratory setting. Studies are ongoing to confirm the MiCheck Prostate algorithm performance using additional clinical sample cohorts.