{"id":492380,"date":"2021-05-12T16:08:58","date_gmt":"2021-05-12T20:08:58","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\/"},"modified":"2021-05-12T16:08:58","modified_gmt":"2021-05-12T20:08:58","slug":"qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\/","title":{"rendered":"QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.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 class=\"bwalignc\"><b>QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li><i>U.S. authorization gives healthcare professionals access to portable rapid testing device that can monitor immune status in relation to COVID-19<\/i><\/li>\n<li><i>Test based on QIAGEN partner Ellume\u2019s proprietary eHub technology and helps ease testing shortfalls by using automation and providing easy-to-read results <\/i><\/li>\n<li><i>eHub digital device can handle eight tests at once, all working independently of each other, can process up to 32 samples per hour, can eventually be used simultaneously with the antigen test<\/i><\/li>\n<\/ul>\n<p>GERMANTOWN, Md. &amp; HILDEN, Germany&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nQIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fast and easy-to-use QIAreach<sup>\u00ae<\/sup> Anti-SARS-CoV-2 Total Test.\n<\/p>\n<p>\nThe authorization means QIAGEN can start making its portable antibody testing device available to health-care professionals in the U.S. Each antibody test takes only about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection. Individual test results are read on a digital eHub device that can process up to 32 tests per hour \u2013 and will eventually also run the antigen test.\n<\/p>\n<p>\nThe QIAreach Anti-SARS-CoV-2 Total Test is a serological test that has been shown to have a sensitivity of 93.85% (CI 84.99\u201398.30%) and a specificity of 97.83 %\u2013%% (CI 95.00\u201399.29%). QIAGEN\u2019s technology detects total antibodies (Total immunoglobulin) specific to SARS-CoV-2 immune response \u2013 while most other tests currently identify only selected antibodies.\n<\/p>\n<p>\nThe QIAreach Anti-SARS-CoV-2 Total Test was developed in partnership with Ellume, an Australian digital diagnostics company. It is the first of two QIAGEN COVID-19 tests to make use of Ellume\u2019s digital eHub and eStick system: QIAGEN in early September 2020 presented the QIAreach SARS-CoV-2 Antigen Test to detect active SARS-CoV-2 infection, which has been submitted to the FDA for an EUA.\n<\/p>\n<p>\nResearch into the SARS-CoV-2 pandemic also requires the monitoring of the immune status of individuals. QIAGEN is the only company that has developed both an antibody and a T-cell test to track immune responses. In November, it also launched the QuantiFERON SARS-CoV-2 test (for research use only) that can detect T-cell responses in people who have had natural infection or vaccination.\n<\/p>\n<p>\n\u201cSerological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection,\u201d said Davide Manissero, Chief Medical Officer of QIAGEN. \u201cAs societies are now returning to normal daily routines, understanding the COVID-19 immunity in a population can help guide public health measures.\u201d\n<\/p>\n<p>\nTraditional rapid lateral-flow antibody tests are hard to automate and results can be hard to read. The QIAreach Anti-SARS-CoV-2 Total Test generates easy-to-read results on the digital eHub platform. Each QIAreach eHub can handle up to eight samples on eight eSticks simultaneously, with each eStick test running independently. QIAGEN is using the same platform to develop QIAreach<sup>\u00ae<\/sup> QuantiFERON<sup>\u00ae<\/sup>-TB, a new testing solution for identifying latent tuberculosis (TB) infections in low-resource regions.\n<\/p>\n<p>\nFurther information on QIAGEN\u2019s response to the coronavirus outbreak can be found <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.qiagen.com%2Fus%2Fapplications%2Finfectious-disease%2Fcoronavirus&amp;esheet=52428649&amp;newsitemid=20210512005959&amp;lan=en-US&amp;anchor=here&amp;index=1&amp;md5=b7009745c8e108e16ba03c94dbbf108e\">here<\/a>.\n<\/p>\n<p><b>About QIAGEN<\/b><\/p>\n<p>\nQIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&amp;D and industrial applications, primarily forensics). As of March 31, 2020, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. Further information can be found at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.qiagen.com&amp;esheet=52428649&amp;newsitemid=20210512005959&amp;lan=en-US&amp;anchor=http%3A%2F%2Fwww.qiagen.com&amp;index=2&amp;md5=2721b512850250a30ec6e4c5462513e3\">http:\/\/www.qiagen.com<\/a>.\n<\/p>\n<p><b>Forward-Looking Statement<\/b><\/p>\n<p><i>Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN&#8217;s products, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and\/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN&#8217;s products (including fluctuations due to general economic conditions, the level and timing of customers&#8217; funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN&#8217;s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors&#8217; products; market acceptance of QIAGEN&#8217;s new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading \u201cRisk Factors\u201d contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission. <\/i><\/p>\n<p>\nCategory: Corporate\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210512005959r1&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\/20210512005959\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20210512005959\/en\/<\/a><\/span><\/p>\n<p><b>QIAGEN<br \/>\n<\/b><br \/><b>Investor Relations<br \/>\n<\/b><br \/>John Gilardi, +49 2103 29 11711<br \/>\n<br \/>Phoebe Loh, +49 2103 29 11457<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:ir@QIAGEN.com\">ir@QIAGEN.com<\/a><\/p>\n<p><b>Public Relations<br \/>\n<\/b><br \/>Thomas Theuringer, +49 2103 29 11826<br \/>\n<br \/>Robert Reitze, +49 2103 29 11676<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:pr@QIAGEN.com\">pr@QIAGEN.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Switzerland United States Austria North America Europe Germany Maryland<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Science Other Science Biotechnology Research Pharmaceutical Health FDA Infectious Diseases<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\" \/>\n","protected":false},"excerpt":{"rendered":"<p>QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies U.S. authorization gives healthcare professionals access to portable rapid testing device that can monitor immune status in relation to COVID-19 Test based on QIAGEN partner Ellume\u2019s proprietary eHub technology and helps ease testing shortfalls by using automation and providing easy-to-read results eHub digital device can handle eight tests at once, all working independently of each other, can process up to 32 samples per hour, can eventually be used simultaneously with the antigen test GERMANTOWN, Md. &amp; HILDEN, Germany&#8211;(BUSINESS WIRE)&#8211; QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies&#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-492380","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies - 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\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies U.S. authorization gives healthcare professionals access to portable rapid testing device that can monitor immune status in relation to COVID-19 Test based on QIAGEN partner Ellume\u2019s proprietary eHub technology and helps ease testing shortfalls by using automation and providing easy-to-read results eHub digital device can handle eight tests at once, all working independently of each other, can process up to 32 samples per hour, can eventually be used simultaneously with the antigen test GERMANTOWN, Md. &amp; HILDEN, Germany&#8211;(BUSINESS WIRE)&#8211; QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug &hellip; Continue reading &quot;QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-05-12T20:08:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210512005959r1&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=\"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\\\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies\",\"datePublished\":\"2021-05-12T20:08:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\\\/\"},\"wordCount\":1129,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20210512005959r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/qiagen-receives-u-s-fda-emergency-use-authorization-for-fast-and-easy-to-use-digital-test-to-detect-sars-cov-2-coronavirus-antibodies\\\/\",\"name\":\"QIAGEN Receives U.S. FDA Emergency Use Authorization for Fast and Easy-to-Use Digital Test to Detect SARS-CoV-2 Coronavirus Antibodies - 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