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.
The Company’s APOE Genotyping test, offered through its DiamiR Biosciences laboratory, first received NYSDOH CLEP approval in August 2025 for blood, buccal swab, saliva, and tissue specimens. The approval, dated October 23, 2026, expands the test’s previously approved specimens to include dried blood spots (FTA card), plasma, and urine.
New York State DOH CLEP maintains stringent validation standards for laboratory-developed tests (LDTs), and clinical laboratories testing specimens from New York residents must obtain a clinical laboratory permit from NYSDOH to help ensure the accuracy and reliability of clinical tests. Modifications to approved tests, including the addition of new specimen types, require the submission and review of validation data by NYDOH. As a result of this approval, Niki BioSolutions can now offer validated APOE genotyping across a broader range of biological samples through its CLIA-certified, College of American Pathologists (CAP) accredited clinical laboratory to licensed healthcare providers in New York State and nationwide.
The inclusion of dried blood spots and urine specimens may be particularly valuable for decentralized and remote-collection settings, allowing at-home or point-of-care sample collection and ambient-temperature shipping without the need for phlebotomy or cold-chain logistics. Plasma compatibility also allows APOE genotyping to be performed on the same specimen type used for Niki BioSolutions’ proprietary microRNA-based brain health assay, supporting integrated genetic and biomarker workflows from a single blood draw.
“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,” said Alidad Mireskandari, Ph.D., 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. 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. 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.”
About APOE Testing
Apolipoprotein E (APOE) is a component of several lipoproteins. The APOE test identifies genetic variants associated with risk for Alzheimer’s disease and other neurological as well as metabolic and cardiovascular conditions. The APOE gene exists in three common variants (ε2, ε3, and ε4), with the APOE ε4 allele being the strongest known genetic risk factor for late-onset Alzheimer's disease. As more data becomes available, it is now estimated that 20% to 25% of the general global population have at least one copy of APOE ε4. Individuals carrying one copy of APOE ε4 have approximately 3-4 times higher risk of developing Alzheimer's disease, while those with two copies have 8-12 times higher risk compared to non-carriers. APOE testing is often used in conjunction with other diagnostic and biomarker assessments to provide a more comprehensive picture of a patient’s neurological health. Recent large-scale studies have demonstrated that lifestyle modifications can meaningfully slow down cognitive decline in APOE ε4 carriers. The APOE genotype e2/e2 is present in approximately 1% of the population and is associated with type III hyperlipoproteinemia (dysbetalipoproteinemia), the main clinical manifestation of which is atherosclerosis leading to coronary artery disease or peripheral vascular disease. Of increasing importance, APOE is now recognized to be involved in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The former represents an increased accumulation of fat in the liver with increased endogenous lipogenesis, while the latter represents a progressive stage of such changes with fibrosis and cirrhosis, making APOE genotyping useful in many sectors of the medical community.
About Niki BioSolutions
Niki BioSolutions is a clinical-stage life sciences company focused on addressing unmet medical needs by developing high-quality genomic and biomarker testing solutions to healthcare providers, research institutions, and life sciences organizations. Through its CLIA-certified, CAP-accredited laboratory, the Company combines proprietary technologies with scientific rigor to support precision medicine across a range of therapeutic areas. Niki BioSolutions collaborates with leading academic centers, disease foundations, and biopharmaceutical companies.
Forward-Looking Statements
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Investor Contact:
Lytham Partners, LLC
Ben Shamsian
646-829-9701
