Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine
Key Highlights
- ➤NYSDOH approval adds dried blood spots, plasma, and urine to APOE genotyping
- ➤Niki can now offer validated APOE testing through its CLIA-certified, CAP-accredited laboratory
- ➤Plasma compatibility enables APOE genotyping alongside Niki’s brain health biomarker assay
- ➤Expanded specimens may support at-home collection and ambient-temperature shipping
Expert Statements
Alidad Mireskandari, President and Chief Operating Officer of Niki BioSolutions
“Expanding the approved specimen types for our APOE Genotyping test advances our objective of making testing more accessible to patients, clinicians, and clinical trial sponsors.”
Alidad Mireskandari, President and Chief Operating Officer of Niki BioSolutions
“The ability to determine APOE status from the same plasma specimen used for biomarker analysis can eliminate the need for a separate collection.”
Alidad Mireskandari, President and Chief Operating Officer of Niki BioSolutions
“Dried blood spot, urine, and plasma options may also reduce practical collection barriers and facilitate the integration of APOE genotyping with our plasma-based brain health biomarker testing.”
Alidad Mireskandari, President and Chief Operating Officer of Niki BioSolutions
“We are pleased that the NYSDOH has recognized the rigor of our validation work as we continue expanding our portfolio of molecular tests for neurodegenerative conditions, including mild cognitive impairment and Alzheimer’s disease.”
NYSDOH CLEP approval extends validated APOE genotyping beyond blood, buccal swab, saliva, and tissue for clinical and research use
NEW HAVEN, CT and PRINCETON, NJ, Oct. 26, 2026 (GLOBE NEWSWIRE) -- Niki BioSolutions, Inc. (NASDAQ: NIKI) (“Niki BioSolutions” or the “Company”), a clinical-stage life sciences company focused on developing advanced genomic and biomarker testing solutions, today announced that its wholly-owned subsidiary, DiamiR Biosciences Corp. (“DiamiR”), has received a Clinical Laboratory Evaluation Program (CLEP) Test Approval from the New York State Department of Health (NYSDOH) expanding the approved specimen types for its APOE Genotyping test which identifies genetic variants associated with the risk for Alzheimer’s disease and other conditions.
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