{"id":939367,"date":"2026-02-24T08:24:07","date_gmt":"2026-02-24T13:24:07","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\/"},"modified":"2026-02-24T08:24:07","modified_gmt":"2026-02-24T13:24:07","slug":"meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\/","title":{"rendered":"Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio"},"content":{"rendered":"<p>        <!--.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p><b>Meridian Bioscience Achieves IVDR Certification for Alethia<sup>\u00ae<\/sup> Molecular Assay Portfolio<\/b><\/p>\n<p>CINCINNATI&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nMeridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has successfully achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017\/746.<\/p>\n<p>\nThe certification, issued by GMED (Notified Body 0459), confirms that the following Alethia assays and associated external controls are compliant with IVDR requirements and are classified as Class C under the regulation:<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nAlethia Pertussis and Alethia Pertussis External Controls<\/p>\n<\/li>\n<li>\nAlethia GBS and Alethia GBS External Controls<\/p>\n<\/li>\n<li>\nAlethia CMV and Alethia CMV External Controls<\/p>\n<\/li>\n<li>\nAlethia Malaria and Alethia Malaria External Controls<\/p>\n<\/li>\n<li>\nAlethia Chlamydia<\/p>\n<\/li>\n<li>\nAlethia Gonorrhea<\/p>\n<\/li>\n<li>\nAlethia HSV 1&amp;2 and Alethia HSV 1&amp;2 External Controls<\/p>\n<\/li>\n<\/ul>\n<p>\nIVDR represents a significant evolution in the European regulatory framework for in vitro diagnostics, introducing more rigorous requirements for clinical evidence, performance evaluation, quality systems, and post-market surveillance. Achieving IVDR certification underscores Meridian\u2019s commitment to delivering high-quality, compliant diagnostic solutions to laboratories and healthcare providers across Europe.<\/p>\n<p>\n\u201cThis milestone reflects the strength of our quality systems and the dedication of our regulatory, quality, and product teams,\u201d said Susan Bogar, Vice President, Regulatory Affairs at Meridian Bioscience. \u201cWe are proud to continue supporting our European customers with IVDR-compliant molecular diagnostics that deliver reliable, actionable results.\u201d<\/p>\n<p>\n\u201cThis achievement reflects Meridian\u2019s unwavering commitment to quality, regulatory excellence and customer continuity,\u201d said Andy Kitzmiller, Chief Executive Officer of Meridian Bioscience. \u201cThe transition to IVDR is one of the most demanding regulatory shifts our industry has faced. Successfully certifying our Alethia product demonstrates the strength of our teams and reinforces our long-term dedication to supporting healthcare providers across Europe with reliable, high-performance molecular diagnostics.\u201d<\/p>\n<p>\nThe Alethia platform provides rapid, easy-to-use molecular testing designed to streamline workflows and deliver accurate detection of infectious diseases in clinical laboratory settings. With IVDR certification in place, Meridian reinforces its long-term commitment to the European market and to maintaining uninterrupted product availability during the industry-wide regulatory transition.<\/p>\n<p>\nMeridian Bioscience will continue to advance its portfolio in alignment with evolving global regulatory standards while supporting customers through ongoing compliance and market access requirements.<\/p>\n<p>\nAbout Meridian Bioscience, Inc.<\/p>\n<p>\nMeridian is a fully integrated life science company that develops, manufactures, markets and distributes diagnostic testing solutions and life science raw materials. Meridian\u2019s diagnostic products provide accurate, simple, and cost-effective testing solutions to aid in the diagnosis and management of gastrointestinal, respiratory, parasitic, and other infectious diseases. The Company\u2019s Life Science segment supplies critical raw materials used by researchers and other diagnostic manufacturers worldwide.<\/p>\n<p>\nFor more information, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.meridianbioscience.com&amp;esheet=54431509&amp;newsitemid=20260224854690&amp;lan=en-US&amp;anchor=www.meridianbioscience.com&amp;index=1&amp;md5=1ef943905d141da7e1eb9efa0246358b\">www.meridianbioscience.com<\/a>.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260224854690r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20260224854690\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260224854690\/en\/<\/a><\/span><\/p>\n<p>\nMichelle Bosch, Vice President, Global Commercial Marketing and Business Management, DIAGNOSTICS<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:michelle.bosch@meridianbioscience.com\">michelle.bosch@meridianbioscience.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Ohio United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Science Other Science Biotechnology Research General Health Health Infectious Diseases Other Health<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\" \/>\n","protected":false},"excerpt":{"rendered":"<p>Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio CINCINNATI&#8211;(BUSINESS WIRE)&#8211; Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has successfully achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017\/746. The certification, issued by GMED (Notified Body 0459), confirms that the following Alethia assays and associated external controls are compliant with IVDR requirements and are classified as Class C under the regulation: Alethia Pertussis and Alethia Pertussis External Controls Alethia GBS and Alethia GBS External Controls Alethia CMV and Alethia CMV External Controls Alethia Malaria and Alethia Malaria External Controls Alethia Chlamydia Alethia Gonorrhea Alethia HSV &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio&#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-939367","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio - 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\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio CINCINNATI&#8211;(BUSINESS WIRE)&#8211; Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has successfully achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017\/746. The certification, issued by GMED (Notified Body 0459), confirms that the following Alethia assays and associated external controls are compliant with IVDR requirements and are classified as Class C under the regulation: Alethia Pertussis and Alethia Pertussis External Controls Alethia GBS and Alethia GBS External Controls Alethia CMV and Alethia CMV External Controls Alethia Malaria and Alethia Malaria External Controls Alethia Chlamydia Alethia Gonorrhea Alethia HSV &hellip; Continue reading &quot;Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-24T13:24:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260224854690r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\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=\"2 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\\\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio\",\"datePublished\":\"2026-02-24T13:24:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\\\/\"},\"wordCount\":497,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20260224854690r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-achieves-ivdr-certification-for-alethia-molecular-assay-portfolio\\\/\",\"name\":\"Meridian Bioscience Achieves IVDR Certification for Alethia\u00ae Molecular Assay Portfolio - 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