DiamiR and Aptorum Score NY Approval for Alzheimer’s Risk Test Ahead of Planned Merger

August 21, 2025

DENVER, Colo., Aug 21, 2025 (247marketnews.com)- DiamiR Biosciences and Aptorum Group Limited (NASDAQ:APM) announced a key regulatory win today as the New York State Department of Health granted CLEP Test Approval for DiamiR’s APOE Genotyping test, a molecular diagnostic tool used to assess genetic risk for late-onset Alzheimer’s disease and related neurological conditions.

The APOE test, now approved for use in New York, can be conducted on blood, saliva, buccal swabs, and tissue samples through DiamiR’s CLIA-certified, CAP-accredited laboratory. New York’s CLEP process is known for its rigorous standards, making this approval a meaningful validation of the test’s clinical reliability.

“This milestone expands access to an important tool that can help inform risk assessment, clinical trial enrollment, and personalized care strategies for individuals at risk of cognitive decline,” said Alidad Mireskandari, Ph.D., CEO of DiamiR.

The APOE ε4 allele is recognized as the strongest genetic risk factor for developing Alzheimer’s. Carriers of one ε4 copy face a 3-4x increased risk, while those with two copies may have up to a 12x higher risk compared to non-carriers. The test is expected to aid in personalized care planning, clinical trial enrollment, and early risk assessment.

This milestone also comes as DiamiR and Aptorum prepare to merge, following a definitive all-stock merger agreement signed on July 14, 2025. Upon closing—expected in Q4 2025, pending shareholder and regulatory approval—DiamiR will become a wholly owned subsidiary of Aptorum Group.

The approval expands DiamiR’s diagnostics footprint and adds momentum to the merger, positioning the combined entity at the forefront of brain health diagnostics and personalized medicine.

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