Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine

The approval adds dried blood spots, plasma, and urine to the test’s previously approved specimen types.

Rhea-AI Summary

Niki BioSolutions (NIKI) received expanded New York State approval for its APOE Genotyping test through its wholly owned subsidiary, DiamiR Biosciences. The approval, dated October 23, 2026, adds dried blood spots on FTA cards, plasma, and urine to the approved specimen types. Blood, cheek swab, saliva, and tissue specimens were first approved in August 2025.

The test identifies genetic variants associated with Alzheimer’s disease risk and other conditions. The expanded approval allows the laboratory to offer validated testing across more sample types to licensed healthcare providers in New York State and nationwide. The company said the added options may reduce collection barriers and allow APOE testing on the same plasma specimen used for its microRNA-based brain health assay.

Positive

• Minor pointOctober 23, 2026 approval expands APOE testing to dried blood spots, plasma, and urine.

Negative

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Market move: NIKI +9.84% vs previous close. APOE genotyping approval

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On Oct 26, the day this news came out, the latest delayed price for NIKI is 9.84% above the previous close. Our momentum scanner has recorded 2 alerts for this stock so far that day. The latest delayed price is $2.01.

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Key Figures

Approval date: October 23, 2026

Approval date

October 23, 2026

NYSDOH CLEP approval added dried blood spots, plasma, and urine

Historical Context

1 past event · Latest: Oct 14

1 event

1. Oct 14

   APOE genotyping partnership

   24h Move

   -18.3%

   Bio-Hermes-002 used DiamiR’s New York State-approved assay on banked plasma without additional blood draws.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

ldts, clia, microrna

3 terms

ldts regulatory

"validation standards for laboratory-developed tests (LDTs)"

Laboratory-developed tests (LDTs) are diagnostic assays that are designed, manufactured, validated and used within a single clinical laboratory rather than sold as commercial test kits to other labs. They are subject to the laboratory's quality and proficiency rules (for example CLIA certification in the U.S.) rather than the same premarket approval or clearance processes that apply to distributed medical devices, a distinction that affects how they are reviewed and overseen by regulators.

clia regulatory

"through its CLIA-certified, College of American Pathologists (CAP) accredited"

CLIA stands for the Clinical Laboratory Improvement Amendments, a U.S. federal program that sets quality and safety standards for laboratories that test human samples. For investors, a CLIA certification is like a safety inspection or license for a lab — it signals that test results are produced under accepted quality controls, affects a lab’s ability to sell or bill certain tests, and therefore influences a company’s regulatory risk, market access, and credibility.

microrna medical

"proprietary microRNA-based brain health assay"

MicroRNA are tiny molecules inside cells that act like dimmer switches for genes, turning down the production of specific proteins. Investors care because changes in microRNA levels can signal disease, serve as targets for new drugs, or be used as precise diagnostic markers, so advances involving microRNA can affect the value and prospects of biotech and healthcare companies.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often use words such as “believe,” “may,” “will,” “estimate,” “target,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “propose,” “plan,” “project,” “forecast,” “predict,” “potential,” “seek,” “future,” “outlook,” and similar variations and expressions. Forward-looking statements are those that do not relate strictly to historical or current facts. Examples of forward-looking statements may include, among others, Niki BioSolutions’ ability to successfully operate its business and provide value to stockholders; Niki BioSolutions’ future financial, business and operating performance and goals; annualized recurring revenue and customer retention; ongoing or future ability to maintain or improve its financial position, cash flows, and liquidity and its expected financial needs; potential financing and ability to obtain financing; acquisition strategy and proposed acquisitions and, if completed, their potential success and financial contributions; strategy and strategic goals, including being able to capitalize on opportunities; expectations relating to Niki BioSolutions and its industry, outlook and market trends; total addressable market and serviceable addressable market and related projections; plans, strategies and expectations for increasing revenue and executing growth initiatives. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity and development of the industries in which Niki BioSolutions operates may differ materially from those made in or suggested by the forward-looking statements. Therefore, investors should not rely on any of these forward-looking statements. Factors that may cause actual results to differ materially include changes in the markets in which Niki BioSolutions operates, the financial markets, economic, business and regulatory factors, and other factors, such as Niki BioSolutions’ ability to execute on its strategies. More detailed information about risk factors can be found in the registration statement on Form S-4 filed with the Securities and Exchange Commission (the “SEC”) on October 6, 2025 (File No. 333-290742), and in other reports filed under the company’s prior name, Aptorum Group Limited, and that will be filed by Niki BioSolutions with the SEC. Niki BioSolutions does not undertake any duty to update forward-looking statements after the date of this press release.

Investor Contact:
Lytham Partners, LLC
Ben Shamsian
646-829-9701

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Which new sample types are approved for Niki BioSolutions’ APOE Genotyping test?

The expanded approval adds dried blood spots on FTA cards, plasma, and urine. The New York State Department of Health approval is dated October 23, 2026. Blood, cheek swab, saliva, and tissue specimens were first approved in August 2025.

How could Niki BioSolutions’ expanded APOE test options support remote sample collection?

The company said dried blood spots and urine may support at-home or point-of-care collection and ambient-temperature shipping without blood draws or temperature-controlled shipping. These options may be useful in decentralized and remote-collection settings.