DiamiR Biosciences Corp. ("DiamiR”), a developer of innovative blood-based diagnostic tests for brain health and other diseases, and Aptorum Group Limited (NASDAQ: APM) ("Aptorum Group” or "Aptorum”), a clinical stage biopharmaceutical company dedicated to addressing unmet medical needs, today announced that DiamiR received a Clinical Laboratory Evaluation Program (CLEP) Test Approval for its APOE Genotyping test from the New York State Department of Health (NYSDOH). This milestone allows DiamiR to offer its validated APOE Genotyping molecular testing in a variety of biological samples, such as blood, buccal swab, saliva, and tissue, through its Clinical Laboratory Improvement Amendments (CLIA) certified, College of American Pathologists (CAP) accredited clinical laboratory by licensed healthcare providers in New York State and nationwide.
The APOE test identifies genetic variants associated with risk for late-onset Alzheimer’s disease and other neurological conditions. The APOE gene exists in three common variants (ε2, ε3, and ε4), with the APOE ε4 allele being the strongest known genetic risk factor for late-onset Alzheimer's disease. Individuals carrying one copy of APOE ε4 have approximately 3-4 times higher risk of developing Alzheimer's disease, while those with two copies have 8-12 times higher risk compared to non-carriers. APOE testing is often used in conjunction with other diagnostic and biomarker assessments to provide a more comprehensive picture of a patient’s neurological health.
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