{"id":1013554,"date":"2026-10-26T13:03:38","date_gmt":"2026-10-26T17:03:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/"},"modified":"2026-10-26T13:03:38","modified_gmt":"2026-10-26T17:03:38","slug":"niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/","title":{"rendered":"Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <i>NYSDOH CLEP approval extends validated APOE genotyping beyond blood, buccal swab, saliva, and tissue for clinical and research use<\/i>\n      <\/p>\n<p>\n        <strong>NEW HAVEN, CT and PRINCETON, NJ, Oct.  26, 2026  (GLOBE NEWSWIRE) &#8212; <\/strong> Niki BioSolutions, Inc. (NASDAQ: NIKI) (\u201cNiki BioSolutions\u201d or the \u201cCompany\u201d), 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. (\u201cDiamiR\u201d), 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\u2019s disease and other conditions.\u00a0 \u00a0\u00a0<\/p>\n<p>The Company\u2019s 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.\u00a0 The approval, dated October 23, 2026, expands the test\u2019s previously approved specimens to include dried blood spots (FTA card), plasma, and urine.<\/p>\n<p>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.\u00a0 Modifications to approved tests, including the addition of new specimen types, require the submission and review of validation data by NYDOH. \u00a0As 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.<\/p>\n<p>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\u2019 proprietary microRNA-based brain health assay, supporting integrated genetic and biomarker workflows from a single blood draw.<\/p>\n<p>\u201cExpanding the approved specimen types for our APOE Genotyping test advances our objective of making testing more accessible to patients, clinicians, and clinical trial sponsors,\u201d said Alidad Mireskandari, Ph.D., President and Chief Operating Officer of Niki BioSolutions. \u201cThe 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\u2019s disease.\u201d<\/p>\n<p>\n        <b>About APOE Testing<\/b>\n      <\/p>\n<p>Apolipoprotein E (APOE) is a component of several lipoproteins. The APOE test identifies genetic variants associated with risk for Alzheimer\u2019s disease and other neurological as well as metabolic and cardiovascular conditions.\u00a0 The APOE gene exists in three common variants (\u03b52, \u03b53, and \u03b54), with the APOE \u03b54 allele being the strongest known genetic risk factor for late-onset Alzheimer&#8217;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 \u03b54. Individuals carrying one copy of APOE \u03b54 have approximately 3-4 times higher risk of developing Alzheimer&#8217;s disease, while those with two copies have 8-12 times higher risk compared to non-carriers. \u00a0APOE testing is often used in conjunction with other diagnostic and biomarker assessments to provide a more comprehensive picture of a patient\u2019s neurological health. Recent large-scale studies have demonstrated that lifestyle modifications can meaningfully slow down cognitive decline in APOE \u03b54 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.<\/p>\n<p>\n        <b>About Niki BioSolutions<\/b>\n      <\/p>\n<p>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.<\/p>\n<p>\n        <b>Forward-Looking Statements<\/b>\n      <\/p>\n<p>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 \u201cbelieve,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cestimate,\u201d \u201ctarget,\u201d \u201ccontinue,\u201d \u201canticipate,\u201d \u201cintend,\u201d \u201cexpect,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201cpropose,\u201d \u201cplan,\u201d \u201cproject,\u201d \u201cforecast,\u201d \u201cpredict,\u201d \u201cpotential,\u201d \u201cseek,\u201d \u201cfuture,\u201d \u201coutlook,\u201d 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\u2019 ability to successfully operate its business and provide value to stockholders; Niki BioSolutions\u2019 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\u2019 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 \u201cSEC\u201d) on October 6, 2025 (File No. 333-290742), and in other reports filed under the company\u2019s 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.<\/p>\n<p>\n        <b>Investor Contact:<\/b><br \/>\n        <br \/>Lytham Partners, LLC<br \/>Ben Shamsian<br \/>646-829-9701<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg1Mjk3OSM3OTE1ODA0IzUwMDEzMTQwMg==\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZDNhNWRlNTEtMjhkOC00MGNiLThhYTItMTIyNDZmN2NhZGM2LTUwMDEzMTQwMi0yMDI2LTEwLTI2LWVu\/tiny\/Niki-BioSolutions-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>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) &#8212; Niki BioSolutions, Inc. (NASDAQ: NIKI) (\u201cNiki BioSolutions\u201d or the \u201cCompany\u201d), 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. (\u201cDiamiR\u201d), 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\u2019s disease and other conditions.\u00a0 \u00a0\u00a0 The Company\u2019s APOE Genotyping test, offered through its DiamiR Biosciences laboratory, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1013554","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"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) &#8212; Niki BioSolutions, Inc. (NASDAQ: NIKI) (\u201cNiki BioSolutions\u201d or the \u201cCompany\u201d), 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. (\u201cDiamiR\u201d), 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\u2019s disease and other conditions.\u00a0 \u00a0\u00a0 The Company\u2019s APOE Genotyping test, offered through its DiamiR Biosciences laboratory, &hellip; Continue reading &quot;Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-10-26T17:03:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg1Mjk3OSM3OTE1ODA0IzUwMDEzMTQwMg==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine\",\"datePublished\":\"2026-10-26T17:03:38+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\\\/\"},\"wordCount\":1181,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTg1Mjk3OSM3OTE1ODA0IzUwMDEzMTQwMg==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\\\/\",\"name\":\"Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine - 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(NASDAQ: NIKI) (\u201cNiki BioSolutions\u201d or the \u201cCompany\u201d), 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. (\u201cDiamiR\u201d), 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\u2019s disease and other conditions.\u00a0 \u00a0\u00a0 The Company\u2019s APOE Genotyping test, offered through its DiamiR Biosciences laboratory, &hellip; Continue reading \"Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/","og_site_name":"Market Newsdesk","article_published_time":"2026-10-26T17:03:38+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg1Mjk3OSM3OTE1ODA0IzUwMDEzMTQwMg==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine","datePublished":"2026-10-26T17:03:38+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/"},"wordCount":1181,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg1Mjk3OSM3OTE1ODA0IzUwMDEzMTQwMg==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/niki-biosolutions-announces-new-york-state-approval-for-its-apoe-genotyping-test-using-dried-blood-spots-plasma-and-urine\/","name":"Niki BioSolutions Announces New York State Approval for Its APOE Genotyping Test Using Dried Blood Spots, Plasma, and Urine - 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