Core Viewpoint - DiamiR Biosciences Corp. has received approval for its APOE Genotyping test from the New York State Department of Health, allowing it to offer this test through its accredited laboratory, which is a significant milestone for the company in expanding its diagnostic capabilities for brain health [1][3][4] Company Overview - DiamiR Biosciences is focused on developing innovative blood-based diagnostic tests for brain health and other diseases, with a particular emphasis on neurodegenerative conditions [1][8] - The company utilizes a proprietary platform technology that analyzes microRNA signatures in plasma for early detection and monitoring of brain health conditions [8] Regulatory Approval - The approval from the New York State Department of Health is part of the Clinical Laboratory Evaluation Program (CLEP), which is known for its stringent validation standards for laboratory-developed tests [2][3] - This approval enables DiamiR to provide its APOE Genotyping test using various biological samples, including blood and saliva, through licensed healthcare providers [1][2] APOE Testing Significance - The APOE test identifies genetic variants linked to the risk of late-onset Alzheimer's disease, with the APOE ε4 allele being the strongest known genetic risk factor [4] - Individuals with one copy of the APOE ε4 allele have a 3-4 times higher risk of developing Alzheimer's, while those with two copies have an 8-12 times higher risk compared to non-carriers [4] Merger Announcement - DiamiR Biosciences and Aptorum Group Limited have entered into a definitive agreement for an all-stock merger, which is expected to close in the fourth quarter of 2025, subject to stockholder approval [6] - Upon completion of the merger, DiamiR will become a wholly-owned subsidiary of Aptorum Group [6] Broader Diagnostic Portfolio - DiamiR's diagnostic portfolio includes tests for monitoring brain health through the analysis of circulating brain-enriched and inflammation-associated microRNAs in blood plasma [5]
DiamiR Biosciences and Aptorum Group Announce New York State Approval for DiamiR's APOE Genotyping Test