DiamiR Biosciences Corp., a developer of blood-based diagnostics for brain health, and Aptorum Group Limited (NASDAQ:APM), a clinical-stage biopharmaceutical firm, announced that New York State’s Department of Health has approved DiamiR’s APOE Genotyping Test under the Clinical Laboratory Evaluation Program (CLEP).
The regulatory milestone allows the test to be offered through DiamiR’s CLIA-certified and CAP-accredited clinical laboratory using multiple sample types—including blood, saliva, buccal swabs, and tissue—by licensed providers both in New York and across the United States.
New York’s CLEP is recognized as one of the most rigorous validation frameworks for laboratory-developed tests (LDTs). Any laboratory testing biospecimens from state residents must secure approval to demonstrate clinical accuracy and reliability.
CEO Statement
“We are very pleased to have received approval from the NYSDOH for our APOE genotyping test and excited about achieving this regulatory milestone as we continue to build our portfolio of molecular tests for brain health, including neurodegenerative diseases such as mild cognitive impairment and Alzheimer’s disease,” said Alidad Mireskandari, Ph.D., CEO of DiamiR Biosciences.
“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,” he added.
About the APOE Test
The APOE genotyping test identifies variants of the APOE gene—ε2, ε3, and ε4—that influence the likelihood of developing late-onset Alzheimer’s and other neurological disorders. Carriers of a single APOE ε4 allele face a three- to four-fold higher risk of developing Alzheimer’s, while those with two copies face up to a twelve-fold increase.
The test is typically used alongside other biomarkers and diagnostic tools to provide a more comprehensive assessment of neurological health. It complements DiamiR’s broader portfolio of blood-based diagnostics, which use microRNA signatures associated with brain function and inflammation to monitor cognitive health and disease progression.
Corporate Update: Merger With Aptorum
The announcement follows the July 14, 2025, agreement for an all-stock merger between DiamiR and Aptorum Group. Upon completion—expected in the fourth quarter of 2025, pending shareholder approval and closing conditions—DiamiR will become a wholly owned subsidiary of Aptorum.
Company Backgrounds
- Aptorum Group (NASDAQ: APM): A clinical-stage biopharmaceutical company focused on oncology, including orphan indications, and infectious diseases.
- DiamiR Biosciences: A private diagnostics company developing minimally invasive brain health tests, backed by more than 50 issued patents worldwide and collaborations with leading academic institutions and pharmaceutical partners.
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