{"id":395581,"date":"2020-12-08T10:20:01","date_gmt":"2020-12-08T15:20:01","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=395581"},"modified":"2020-12-08T10:20:01","modified_gmt":"2020-12-08T15:20:01","slug":"meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/","title":{"rendered":"Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">CINCINNATI, Dec.  08, 2020  (GLOBE NEWSWIRE) &#8212; Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced that it has submitted its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the company\u2019s SARS-CoV-2 molecular diagnostic test on the Revogene<sup>\u00ae<\/sup> platform.<\/p>\n<p align=\"justify\">The SARS-CoV-2 test is a molecular diagnostic test for the qualitative detection of the SARS-CoV-2 virus, the causative agent of COVID-19. The COVID-19 global pandemic has resulted in a need for accurate and timely results to quickly determine which patients are infected with COVID-19. With results available as early as 47 minutes, the Revogene<sup>\u00ae<\/sup> SARS-CoV-2 test will help customers improve their testing capacity and enable healthcare providers to quickly deliver appropriate care and guide infection control measures for patients. The Revogene<sup>\u00ae<\/sup> is a flexible molecular testing platform that can be easily integrated into any laboratory or health system.<\/p>\n<p align=\"justify\">\u201cAs this is our first RNA based molecular assay, the Revogene<sup>\u00ae<\/sup> SARS-CoV-2 test is a significant milestone for the Revogene platform and will open up additional opportunities to grow our respiratory franchise,\u201d said Tony Serafini-Lamanna, Executive Vice President &#8211; Diagnostics. \u201cWith increased manufacturing capability, and assay performance supported by a good dataset, we believe this is the right COVID-19 assay to offer to our customers.\u201d<\/p>\n<p align=\"left\">For more information on the Revogene<sup>\u00ae<\/sup> SARS-CoV-2 test, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=TGk-BrcttVMBpgWbRklfrFSPvxamJ5QsRVG_Ms_cAjBAvO_P3ws5gqJB_4QGL5PLqp-sH6Qy_UnaoiQzNrHOa8cF4sUHLOzQZSd9ZTJE6NTeKHECTEYhw55ILh-5tofazP-F0rhABfBmij4uIVFTjpLkOSCUEr_p_ail7tUAsjJJaM5q1tuL8Gp6ujSyEhEpxGQvE9Z_5tDCPLFWIFkb7Io1slM0FB3JOTRH5qOwQDDOT9mFT-L4gLV6_e-xjIjkirfxaG9bEwLnyQdvuJgKL6JnL9_wQikvTlvQ50LfHAk=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">https:\/\/www.meridianbioscience.com\/human-condition\/respiratory\/coronavirus\/revogene-sars-cov-2\/<\/a>.<\/p>\n<p>\n        <em>The Revogene<\/em><br \/>\n        <sup>\u00ae<\/sup><br \/>\n        <em> SARS-CoV-2 Molecular Diagnostic Test has not been FDA cleared or approved.<\/em>\n      <\/p>\n<p align=\"justify\">\n        <strong>About Meridian Bioscience, Inc.<\/strong><br \/>\n        <br \/>Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.<\/p>\n<p align=\"justify\">Meridian\u2019s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian\u2019s website address is <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=wly3siqiaL3j6en8tBEuBlnK395mUFEaFLWSpCNIuDoX5v9vcXXqZRBsfKaDON6WWoLoS9mcdvLkve1gw3VEStvtVKyYRUuIzhA26I2-YN9AlId-qcuBsBGk3toAMwJj\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.meridianbioscience.com<\/a>.<\/p>\n<p>\n        <strong>Contact:<\/strong><br \/>\n        <br \/>Charlie Wood<br \/>Vice President \u2013 Investor Relations<br \/>Meridian Bioscience, Inc.<br \/>Phone: +1 513.271.3700<br \/>Email: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=1IVpzbtJlyQrnqrHHJMeF2ptijnOJcjxjMVW4NHIV3EQpHDu7-GMjSp22JPII7dbEc-aVnD0Vj3EmVzp5HcHU5xH1ZHoH13DAgN8Xms_zxaxITgipkCpdI9E4Um90vASEzhKzxNEgYQlcyHIPA0pSh_-_9YrHPT9n3Za1a0LBfRIZURVEBAd-YXRGSgKnBH2\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">mbi@meridianbioscience.com<\/a><\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5ODczMiMzODYxNzg2IzIwMDYwNjY=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/ef43fce1-c38c-431e-96d9-dd05da5e8f95\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CINCINNATI, Dec. 08, 2020 (GLOBE NEWSWIRE) &#8212; Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced that it has submitted its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the company\u2019s SARS-CoV-2 molecular diagnostic test on the Revogene\u00ae platform. The SARS-CoV-2 test is a molecular diagnostic test for the qualitative detection of the SARS-CoV-2 virus, the causative agent of COVID-19. The COVID-19 global pandemic has resulted in a need for accurate and timely results to quickly determine which patients are infected with COVID-19. With results available as early as 47 minutes, the Revogene\u00ae SARS-CoV-2 test will help customers improve their testing capacity and enable &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay&#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-395581","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay - 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-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CINCINNATI, Dec. 08, 2020 (GLOBE NEWSWIRE) &#8212; Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced that it has submitted its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the company\u2019s SARS-CoV-2 molecular diagnostic test on the Revogene\u00ae platform. The SARS-CoV-2 test is a molecular diagnostic test for the qualitative detection of the SARS-CoV-2 virus, the causative agent of COVID-19. The COVID-19 global pandemic has resulted in a need for accurate and timely results to quickly determine which patients are infected with COVID-19. With results available as early as 47 minutes, the Revogene\u00ae SARS-CoV-2 test will help customers improve their testing capacity and enable &hellip; Continue reading &quot;Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-08T15:20:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5ODczMiMzODYxNzg2IzIwMDYwNjY=\" \/>\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-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay\",\"datePublished\":\"2020-12-08T15:20:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\\\/\"},\"wordCount\":421,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODA5ODczMiMzODYxNzg2IzIwMDYwNjY=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\\\/\",\"name\":\"Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay - 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(NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced that it has submitted its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the company\u2019s SARS-CoV-2 molecular diagnostic test on the Revogene\u00ae platform. The SARS-CoV-2 test is a molecular diagnostic test for the qualitative detection of the SARS-CoV-2 virus, the causative agent of COVID-19. The COVID-19 global pandemic has resulted in a need for accurate and timely results to quickly determine which patients are infected with COVID-19. With results available as early as 47 minutes, the Revogene\u00ae SARS-CoV-2 test will help customers improve their testing capacity and enable &hellip; Continue reading \"Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/","og_site_name":"Market Newsdesk","article_published_time":"2020-12-08T15:20:01+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5ODczMiMzODYxNzg2IzIwMDYwNjY=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay","datePublished":"2020-12-08T15:20:01+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/"},"wordCount":421,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5ODczMiMzODYxNzg2IzIwMDYwNjY=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/meridian-bioscience-submits-application-to-fda-for-emergency-use-authorization-for-sars-cov-2-molecular-assay\/","name":"Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay - 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