{"id":3506,"date":"2024-08-20T10:00:50","date_gmt":"2024-08-20T10:00:50","guid":{"rendered":"https:\/\/amoneta-diagnostics.com\/?p=3506"},"modified":"2025-10-20T20:24:52","modified_gmt":"2025-10-20T18:24:52","slug":"amoneta-diagnostics-obtains-ce-marking-certification-under-the-ivdr-for-apo-easy-genotyping-kit","status":"publish","type":"post","link":"https:\/\/alzevit.com\/en\/amoneta-diagnostics-obtains-ce-marking-certification-under-the-ivdr-for-apo-easy-genotyping-kit\/","title":{"rendered":"Amoneta Diagnostics gains CE-marking for APO-Easy\u00ae Genotyping Kit under EU IVDR"},"content":{"rendered":"<p>Huningue, France \u2013 August, 20, 2024 \u2013 Amoneta Diagnostics SAS, a biotech company specialized in developing innovative biomarkers for neurodegenerative diseases, today announces the certification of its leading in-vitro diagnostic (IVD) kit APO-Easy\u00ae Genotyping Kit under the European Union\u2019s new In-Vitro Diagnostic Medical Devices Regulation 2017\/746 (IVDR).<\/p>\n<p>The IVDR certification was issued by the Notified Body BSI after successful stages 1 &amp; 2 audits and technical documentation assessment.<\/p>\n<p>It allows the marketing and distribution of the APO-Easy\u00ae genotyping kit across Europe, marking a significant step forward in Amoneta\u2019s mission to improve care for patients with neurodegenerative diseases.<\/p>\n<h6>APO-Easy\u00ae is the first CE-marked kit under the IVDR for APOE genotyping by PCR, to be commercialized in Europe.<\/h6>\n<p>\u201cWe are delighted to announce that our APO-Easy\u00ae Genotyping Kit has achieved CE-marking under the IVDR,\u00a0\u00bb said St\u00e9phanie BOUTILLIER, PhD, Chief Executive Officer at Amoneta Diagnostics SAS. \u00ab\u00a0This achievement is the result of several years of dedicated work by our team, for developing a solution that meets the specific needs of clinicians and biological diagnostic laboratories. This milestone highlights our commitment to quality and innovation, ensuring we provide a reliable and effective tool that will make a significant impact in medical diagnostics.\u00a0\u00bb<\/p>\n<p>CE-marking under the EU IVDR represents a crucial milestone for the APO-Easy\u00ae Genotyping kit. It\u00a0signifies that the test meets the stringent safety, quality, and performance requirements established by the IVDR, ensuring its reliability and effectiveness in medical diagnostics.<\/p>\n<p>The APO-Easy\u00ae Genotyping Kit represents a major advancement in diagnostic technology. It is a ready to use qualitative in vitro diagnostic (IVD) test based on Real-Time Polymerase Chain Reaction (RT-PCR), designed for the precise detection of two single-nucleotide polymorphisms (SNPs): rs429358 and rs7412. By using fluorescently labeled probes (FAM and VIC), the kit enables accurate allelic discrimination and APOE genotype determination from human genomic. APO-Easy\u00ae Genotyping Kit can be used in any certified diagnostic laboratory or healthcare provider facility.<\/p>\n<p>\u201cPreviously considered as a risk factor for Alzheimer\u2019s Disease, recent literature reported increasing value of the APO-E4 genotype as an early diagnostic marker, alone or in combination with other emerging biomarkers,\u00a0\u00bb said Prof. Audrey GABELLE, PU-PH, Neurologist at the CHU Gui de Chauliac of Montpellier (France). \u00ab\u00a0For patients who are eligible for new anti-amyloid drugs, APOE genotyping is now recommended by the FDA for better monitoring of adverse effect induced by these disease-modifying therapies, demonstrating the importance of tests such as the APO-Easy\u00ae Genotyping Kit.\u00a0\u00bb<\/p>\n<h6>APO-Easy\u00ae is currently under review by the FDA for its IVD approval in the US, which is expected Q4-2024\/Q1-2025.<\/h6>\n<style>\/*! elementor - v3.19.0 - 28-02-2024 *\/<br \/>.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style>\n<h2>About APO-Easy\u00ae Genotyping Kit<\/h2>\n<h3>Key features:<\/h3>\n<ul>\n<li>Utilizes qPCR with fluorescently labeled probes for high-precision genotyping, ensuring accurate detection of the -\u03b52, -\u03b53, and -\u03b54 alleles.<\/li>\n<li>Delivers 100% specificity and reliability, with no false positive or false negative results.<\/li>\n<li>Clinically validated through multicentric studies involving ~960 patients across seven countries with various neurodegenerative conditions, including Alzheimer\u2019s Disease (AD), Mild Cognitive Impairment (MCI), Frontotemporal Dementia (FTD), Lewy Body Dementia (LBD), Parkinson\u2019s Disease Dementia (PDD), Cortico-Basal Degeneration (CBD), and Progressive Supranuclear Palsy (PSP).<\/li>\n<\/ul>\n<h2>About Amoneta Diagnostics SAS<\/h2>\n<p>Amoneta Diagnostics is a French biotech company seeking, developing, and qualifying innovative biomarkers for the development of diagnostic solutions in the field of neurological diseases such as Alzheimer&rsquo;s Disease to revolutionize patient care and advance precision medicine. The company has a large portfolio of patents related to blood biomarkers, including a new class of non-coding RNAs as diagnostic targets for AD and other types of dementia (on which MemoryLinc\u00ae and NeuroLINCs are based-products). In addition to the APO-Easy\u00ae Genotyping Kit, Amoneta has also developed the innovative NeuroDeGene\u00ae product, which is a DNA-targeted sequencing panel for the detection of more than 15,000 SNPs (including APOE) and INDELS associated with 19 neurodegenerative diseases.<\/p>\n<p>For more information about our comprehensive diagnostic solutions, visit <a href=\"https:\/\/alzevit.com\/products\/\">https:\/\/alzevit.com\/products\/<\/a> or send a message to <a href=\"mailto:contact@amoneta-diagnostics.com\">contact@amoneta-diagnostics.com\u00a0<\/a><\/p>\n<p>More information about the APO-Easy\u00ae Genotyping Kit can be found at <a href=\"https:\/\/alzevit.com\/products\/apo-easy\/\" target=\"_blank\" rel=\"noopener\">https:\/\/alzevit.com\/products\/apo-easy\/<\/a><\/p>\n<h3>PRESS CONTACT<\/h3>\n<p>Malak Ftouhi &#8211; Head of Communications &#8211; +33 3 89 91 13 20 &#8211; <a href=\"mailto:marketing@firalis.com\">marketing@firalis.com<\/a><\/p>\n<p><a href=\"https:\/\/alzevit.com\/news-events\/\"><br \/>\nVIEW ALL NEWS<br \/>\n<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Amoneta announces the CE-marking under the EU-IVDR of its APO-Easy\u00ae Genotyping Kit.<\/p>","protected":false},"author":1,"featured_media":3123,"comment_status":"closed","ping_status":"closed","sticky":true,"template":"","format":"standard","meta":{"footnotes":""},"categories":[78],"tags":[81,83],"class_list":["post-3506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-neurology","tag-products","cms-has-post-thumbnail"],"_links":{"self":[{"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/posts\/3506","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/comments?post=3506"}],"version-history":[{"count":3,"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/posts\/3506\/revisions"}],"predecessor-version":[{"id":4597,"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/posts\/3506\/revisions\/4597"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/media\/3123"}],"wp:attachment":[{"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/media?parent=3506"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/categories?post=3506"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/alzevit.com\/en\/wp-json\/wp\/v2\/tags?post=3506"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}