DiamiR Biosciences and Aptorum Group Announce New York State Approval for DiamiR’s APOE Genotyping Test
DiamiR Biosciences and Aptorum Group (NASDAQ: APM) have announced that DiamiR has received Clinical Laboratory Evaluation Program (CLEP) Test Approval from the New York State Department of Health for its APOE Genotyping test.
This regulatory milestone enables DiamiR to provide validated APOE Genotyping molecular testing through its CLIA-certified and CAP-accredited clinical laboratory. The test can analyze various biological samples including blood, buccal swab, saliva, and tissue, and will be available to licensed healthcare providers in New York State and nationwide.
The approval expands access to a diagnostic tool for brain health assessment, particularly for neurodegenerative conditions like mild cognitive impairment and Alzheimer's disease.
DiamiR Biosciences e Aptorum Group (NASDAQ: APM) hanno comunicato che DiamiR ha ottenuto l'approvazione CLEP (Clinical Laboratory Evaluation Program) dal Dipartimento della Salute dello Stato di New York per il suo test di genotipizzazione APOE.
Questo traguardo normativo permette a DiamiR di offrire il test molecolare APOE convalidato tramite il suo laboratorio clinico certificato CLIA e accreditato CAP. Il test può analizzare diversi tipi di campione biologico, tra cui sangue, tampone buccale, saliva e tessuto, ed è disponibile per operatori sanitari autorizzati nello Stato di New York e a livello nazionale.
La autorizzazione amplia l'accesso a uno strumento diagnostico per la valutazione della salute cerebrale, in particolare nelle condizioni neurodegenerative come il decadimento cognitivo lieve e la malattia di Alzheimer.
DiamiR Biosciences y Aptorum Group (NASDAQ: APM) anunciaron que DiamiR ha recibido la aprobación CLEP (Clinical Laboratory Evaluation Program) del Departamento de Salud del Estado de Nueva York para su prueba de genotipado APOE.
Este hito regulatorio permite a DiamiR ofrecer la prueba molecular APOE validada a través de su laboratorio clínico certificado CLIA y acreditado por CAP. La prueba puede analizar distintos tipos de muestras biológicas, incluidos sangre, hisopo bucal, saliva y tejido, y estará disponible para proveedores de salud autorizados en el Estado de Nueva York y en todo el país.
La aprobación amplía el acceso a una herramienta diagnóstica para evaluar la salud cerebral, especialmente en enfermedades neurodegenerativas como el deterioro cognitivo leve y el Alzheimer.
DiamiR Biosciences와 Aptorum Group (NASDAQ: APM)은 DiamiR이 뉴욕주 보건부로부터 APOE 유전자형 검사에 대해 CLEP(Clinical Laboratory Evaluation Program) 시험 승인을 받았다고 발표했습니다.
이번 규제 승인으로 DiamiR은 CLIA 인증 및 CAP 공인 임상검사실을 통해 검증된 APOE 분자 검사를 제공할 수 있게 되었습니다. 해당 검사는 혈액, 구강 면봉, 타액, 조직 등 다양한 생물학적 시료를 분석할 수 있으며, 뉴욕주 및 전국의 허가된 의료 제공자들에게 제공됩니다.
이번 승인은 경도 인지장애 및 알츠하이머병과 같은 신경퇴행성 질환을 포함한 뇌 건강 평가를 위한 진단 도구에 대한 접근성을 확대합니다.
DiamiR Biosciences et Aptorum Group (NASDAQ: APM) ont annoncé que DiamiR a obtenu l'approbation CLEP (Clinical Laboratory Evaluation Program) du Département de la Santé de l'État de New York pour son test de génotypage APOE.
Cette étape réglementaire permet à DiamiR de proposer le test moléculaire APOE validé via son laboratoire clinique certifié CLIA et accrodité CAP. Le test peut analyser divers échantillons biologiques, notamment le sang, les frottis buccaux, la salive et les tissus, et sera disponible pour les prestataires de soins autorisés dans l'État de New York et à l'échelle nationale.
Cette approbation élargit l'accès à un outil diagnostique pour l'évaluation de la santé cérébrale, en particulier pour les affections neurodégénératives comme le trouble cognitif léger et la maladie d'Alzheimer.
DiamiR Biosciences und Aptorum Group (NASDAQ: APM) haben bekanntgegeben, dass DiamiR die CLEP-Prüfzulassung (Clinical Laboratory Evaluation Program) vom New York State Department of Health für seinen APOE-Genotypisierungstest erhalten hat.
Dieser regulatorische Meilenstein erlaubt es DiamiR, den validierten molekularen APOE-Test über sein CLIA-zertifiziertes und CAP-akkreditiertes klinisches Labor anzubieten. Der Test kann verschiedene biologische Proben wie Blut, Wangenabstrich, Speichel und Gewebe analysieren und steht lizenzierten Gesundheitsdienstleistern in New York State und landesweit zur Verfügung.
Die Zulassung erweitert den Zugang zu einem diagnostischen Instrument zur Beurteilung der Gehirngesundheit, insbesondere bei neurodegenerativen Erkrankungen wie leichter kognitiver Beeinträchtigung und Alzheimer.
- Received NYSDOH CLEP approval for APOE Genotyping test
- Test can be offered nationwide through CLIA-certified and CAP-accredited laboratory
- Versatile testing capabilities across multiple biological sample types
- Expands diagnostic options for neurodegenerative disease assessment
- None.
Insights
NYSDOH approval for DiamiR's APOE Genotyping test expands Aptorum's diagnostic portfolio for neurodegenerative diseases with significant market potential.
The approval of DiamiR's APOE Genotyping test by the New York State Department of Health represents a significant regulatory milestone for both DiamiR Biosciences and Aptorum Group. The APOE gene is widely recognized as the strongest genetic risk factor for late-onset Alzheimer's disease, making this test particularly valuable in the neurodegenerative disease space.
The NYSDOH Clinical Laboratory Evaluation Program is known for its stringent validation standards, which means this approval carries substantial credibility in the diagnostic industry. By meeting these high regulatory hurdles, DiamiR demonstrates the robustness of their testing methodology and validation processes.
What makes this development particularly noteworthy is the test's versatility across multiple biological sample types - including blood, buccal swab, saliva, and tissue. This flexibility enhances clinical utility by allowing healthcare providers to choose the least invasive or most appropriate collection method for individual patients.
For Aptorum Group, this expansion of diagnostic capabilities aligns with the growing emphasis on biomarker-driven approaches in neurodegenerative disease management. The APOE genotyping test can inform risk stratification, clinical trial enrollment, and personalized treatment strategies - all increasingly important as novel therapeutics for Alzheimer's disease enter the market.
The timing is particularly advantageous as the Alzheimer's diagnostic and therapeutic landscape undergoes transformation with recent FDA approvals of disease-modifying treatments. APOE status is becoming increasingly relevant for treatment decisions, potentially creating substantial demand for accessible and reliable genotyping services nationwide.
NEW YORK, NY, NEW HAVEN, CT, and PRINCETON, N.J., Aug. 21, 2025 (GLOBE NEWSWIRE) -- DiamiR Biosciences Corp. (“DiamiR”), a developer of innovative blood-based diagnostic tests for brain health and other diseases, and Aptorum Group Limited (NASDAQ: APM) ("Aptorum Group” or “Aptorum”), a clinical stage biopharmaceutical company dedicated to addressing unmet medical needs, today announced that DiamiR received a Clinical Laboratory Evaluation Program (CLEP) Test Approval for its APOE Genotyping test from the New York State Department of Health (NYSDOH). This milestone allows DiamiR to offer its validated APOE Genotyping molecular testing in a variety of biological samples, such as blood, buccal swab, saliva, and tissue, through its Clinical Laboratory Improvement Amendments (CLIA) certified, College of American Pathologists (CAP) accredited clinical laboratory by licensed healthcare providers in New York State and nationwide.
New York State DOH CLEP is known for having stringent validation standards for laboratory-developed tests (LDTs). Clinical laboratories testing biospecimens from New York residents must obtain a clinical laboratory permit from NYSDOH to help ensure the accuracy and reliability of clinical tests.
“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.”
About APOE Testing
The APOE test identifies genetic variants associated with risk for late-onset Alzheimer’s disease and other neurological 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. 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.
DiamiR’s broader diagnostic portfolio focuses on detecting and monitoring brain health status through the analysis of circulating brain-enriched and inflammation-associated microRNAs in blood plasma.
Merger between Aptorum Group and DiamiR Biosciences
As was previously announced, on July 14, 2025, DiamiR Biosciences and Aptorum Group Limited (NASDAQ: APM) entered into a definitive agreement for an all-stock merger transaction. As a result of this transaction and subject to stockholder approval of both companies and customary closing conditions, DiamiR Biosciences will become a wholly-owned subsidiary of Aptorum Group upon consummation of the merger. The transaction is expected to close in the fourth quarter of 2025.
About Aptorum Group
Aptorum Group Limited (Nasdaq: APM) is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly in oncology (including orphan oncology indications) and infectious diseases. For more information, please visit the company’s website at www.aptorumgroup.com.
About DiamiR Biosciences
DiamiR is a private molecular diagnostics company focused on developing and commercializing minimally invasive tests offered through its CLIA certified, CAP accredited laboratory for early detection and monitoring of brain health conditions and other diseases in clinical trials and clinical practice settings. DiamiR’s proprietary platform technology, protected by over 50 issued patents worldwide, is based on quantitative analysis of organ-enriched, including brain-enriched and inflammation-associated, microRNA signatures in plasma for screening, patient stratification, as well as disease progression and treatment monitoring. In addition, DiamiR offers protein and genetic biomarker analyses. DiamiR collaborates with leading academic centers, disease foundations, and biopharma companies. For more information, please visit the company's website at www.diamirbio.com and connect with DiamiR on LinkedIn.
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, statements regarding the consummation and closing of the proposed merger, the satisfactory completion of all conditions to the merger, the shareholder’s approval necessary for the issuance of shares in the merger and re-domestication of Aptorum, Aptorum’s and DiamiR’s ability to successfully operate its business and provide value to stockholders after completion of the merger, Aptorum’s and DiamiR’s future financial, business and operating performance and goals; annualized recurring revenue and customer retention; ongoing, future or 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 Aptorum’s and DiamiR’s 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 Aptorum and DiamiR operate 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 Aptorum and DiamiR operate, the financial markets, economic, business and regulatory and other factors, such as Aptorum’s and DiamiR’s ability to execute on their strategies. More detailed information about risk factors can be found in the Aptorum’s Annual Report on Form 20-F under the heading “Risk Factors,” and in other reports filed by the Aptorum, including reports on Form 6-K. Aptorum and DiamiR do not undertake any duty to update forward-looking statements after the date of this press release.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any proxy, consent, authorization, vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of the U.S. Securities Act of 1933, as amended.
Additional Information About the Proposed Merger and Where to Find It
In connection with the merger, Aptorum filed a current report on Form 6-K to disclose additional details about the merger, and will file registration statement on Form S-4 with the SEC, and will mail notices of shareholders meeting and other relevant documents to its shareholders. Investors and security holders of Aptorum are advised to read, when available, the From S-4, and amendments thereto, the notice to shareholders, and amendments thereto, in connection with Aptorum’s solicitation of proxies for its shareholder' meeting to be held to approve the proposed merger because the notice to shareholders will contain important information about the transaction and the parties to the transaction, and stockholders are urged to read the proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the merger and related proposals. The notices to shareholders will be mailed to Aptorum’s shareholders as of a record date to be established for voting on the transactions. Shareholders will also be able to obtain copies of the notice, without charge, once available, at the SEC's website at www.sec.gov or by directing a request to: Ian Huen, telephone: +44 20 80929299.
A registration statement relating to the securities will be filed with the SEC but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A copy of Aptorum's registration statement on Form S-4, once available, can be viewed on the SEC's website.
Participants in the Solicitation
Aptorum Group, DiamiR and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from stockholders in connection with the merger. Information about Aptorum's directors and executive officers including a description of their interests in Aptorum is included in Aptorum’s most recent Annual Report on Form 20-F, including any information incorporated therein by reference, as filed with the SEC. Additional information regarding these persons and their interests in the transaction will be included in the proxy statement/prospectus relating to the merger when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.
For more information, please contact:
Aptorum Group Limited
Investor Relations Department
investor.relations@aptorumgroup.com
+44 20 80929299
DiamiR Biosciences
Alidad Mireskandari
203-570-8275
amireskandari@diamirbio.com
FAQ
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