DiamiR Biosciences Corp. and Aptorum Group Limited announced on August 21, 2025, that DiamiR received Clinical Laboratory Evaluation Program (CLEP) Test Approval for its APOE Genotyping test from the New York State Department of Health (NYSDOH). This approval is a significant regulatory milestone.
The approval allows DiamiR to offer its validated APOE Genotyping molecular testing nationwide through its CLIA-certified and CAP-accredited clinical laboratory. The test can be performed on various biological samples, including blood, buccal swab, saliva, and tissue.
The APOE Genotyping test identifies genetic variants (ε2, ε3, and ε4) associated with the risk for late-onset Alzheimer’s disease and other neurological conditions. This milestone expands access to an important tool for risk assessment, clinical trial enrollment, and personalized care strategies for individuals at risk of cognitive decline, providing a tangible pathway to revenue generation for the combined company.
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