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.
Minomic CEO Brad Walsh said: “This is an important step in the commercialisation process in the US for our MiCheck® Prostate LDT.”
“Our US team will be rolling out the test in the world’s largest healthcare market, serving patients and clinicians.”
“It is estimated that about two million American men undergo transrectal biopsies each year to diagnose prostate cancer. About 1-3% of these can lead to sepsis and death, while only 250,000 are diagnosed with prostate cancer.”
“Clearly many of these biopsies are unnecessary, which is why urologists see an unmet need for a more specific test to assist them to identify the right patients to biopsy. In the coming weeks, we look forward to sharing the findings from studies currently in progress for MiCheck® Prostate.”