DiamiR Biosciences and Aptorum Group announced that New York State granted Clinical Laboratory Evaluation Program (CLEP) approval for DiamiR’s APOE Genotyping test, according to the company. The company said that this regulatory milestone enables it to offer the validated molecular test through its CLIA-certified, CAP-accredited clinical laboratory.
The company claims that the test can analyze multiple biological sample types including blood, buccal swab, saliva, and tissue, and is now available to licensed healthcare providers in New York State and nationwide. The company said that the approval builds on its portfolio of molecular tests for brain health, targeting conditions such as mild cognitive impairment and Alzheimer’s disease.
The company said that APOE genotyping can contribute to risk assessment, clinical trial enrollment, and personalized care strategies for individuals at risk of cognitive decline. The company claims that this step follows its all-stock merger agreement with Aptorum Group, under which DiamiR Biosciences will become a wholly owned subsidiary—pending stockholder approval and customary closing conditions expected in the fourth quarter of 2025.
