APOE Genotyping
New York State-approved APOE testing
Niki now offers New York State-approved APOE testing from blood, plasma, dried blood spot, saliva, buccal swab, urine, or tissue.
The APOE gene is the strongest known genetic risk factor for late-onset Alzheimer’s disease. It exists in three common variants — ε2, ε3, and ε4. Individuals carrying one copy of the ε4 allele have roughly three to four times the risk of developing Alzheimer’s disease; those with two copies have eight to twelve times the risk compared with non-carriers. APOE status also informs eligibility and safety monitoring for anti-amyloid therapies and is widely used in clinical trial enrollment and stratification.
Niki’s APOE Genotyping test is a PCR-based laboratory-developed test performed in our CLIA-certified, CAP-accredited laboratory. It received New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) approval in August 2025, with an expanded approval in October 2026 adding plasma, dried blood spot, and urine specimen types. NYSDOH CLEP is recognized as one of the most rigorous validation standards for laboratory-developed tests in the United States, and approval allows us to accept specimens from New York residents as well as nationwide.
Why plasma matters
Few clinical laboratories have validated and received regulatory approval to genotype APOE directly from plasma. This allows APOE status to be determined from the same plasma specimen collected for DiamiR’s microRNA-based brain health assays and other biomarker testing — one draw, one tube, no separate genetic sample. For clinical trial sponsors, this simplifies protocols and reduces specimen handling; for clinicians, it removes a step for the patient.
Flexible collection options
Plasma
Integrates with biomarker testing from a single draw
Whole blood
Standard venipuncture collection
Dried blood spot (FTA card)
Fingerstick collection, ambient shipping, suited to remote and decentralized studies
Saliva or buccal swab
Non-invasive, self-collected
Urine
Fully non-invasive
Tissue
For research applications
Who it’s for
Clinicians
Assessing Alzheimer’s risk or evaluating candidates for anti-amyloid therapy
Clinical trial sponsors and CROs
Requiring validated APOE status for enrollment, stratification, or safety monitoring
Academic and biopharma researchers
Studying neurodegeneration, cardiovascular disease, and lipid metabolism
Ordering
APOE Genotyping is available to licensed healthcare providers and research organizations. Results are reported as the APOE genotype (e.g., ε3/ε4). Contact us for requisition forms, collection kits, turnaround times, and research or volume pricing.