{"id":5823,"date":"2020-04-17T12:46:46","date_gmt":"2020-04-17T12:46:46","guid":{"rendered":"https:\/\/staging.asminternational.org\/edfas\/thermo-fisher-receives-ce-mark-in-europe-for-diagnostic-test-to-detect-covid-19\/"},"modified":"2023-02-23T21:27:59","modified_gmt":"2023-02-23T21:27:59","slug":"thermo-fisher-receives-ce-mark-in-europe-for-diagnostic-test-to-detect-covid-19","status":"publish","type":"post","link":"https:\/\/www.asminternational.org\/edfas\/results\/-\/journal_content\/56\/10192\/40251246\/NEWS\/","title":{"rendered":"Thermo Fisher receives CE mark in Europe for diagnostic test to detect COVID-19"},"content":{"rendered":"<p style=\"margin-bottom:.0001pt\"><span style=\"line-height:normal\">Thermo Fisher Scientific, Waltham, Mass., announces that it has received the CE mark in the European Union for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.<\/span><\/p>\n<p style=\"margin-bottom:.0001pt\">&nbsp;<\/p>\n<p style=\"margin-bottom:.0001pt\"><span style=\"line-height:normal\">The Thermo Fisher test uses Applied Biosystems TaqPath Assay and real-time PCR technology. It is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.<\/span><\/p>\n<p style=\"margin-bottom:.0001pt\">&nbsp;<\/p>\n<p style=\"margin-bottom:.0001pt\"><span style=\"line-height:normal\">This CE mark represents Thermo Fisher&#8217;s assurance that its test complies with the European Union&#8217;s In vitro Diagnostic Directive, which applies to products that are manufactured in,or designed to be sold in the European Economic Area.<\/span><\/p>\n<p style=\"margin-bottom:.0001pt\">&nbsp;<\/p>\n<p style=\"margin-bottom:.0001pt\"><span style=\"line-height:normal\">Thermo Fisher Scientific received Emergency Use Authorization by the U.S. Food and Drug Administration for its COVID-19 test on March 13, 2020. This authorization was amended on March 24, 2020, to include additional instruments, such as the company&#8217;s Applied Biosystems 7500 Fast Real-Time PCR System. This expands testing capabilities in the U.S. from approximately 1,000 instruments to more than 3,000 instruments on which Thermo Fisher&#8217;s diagnostic test can be run. The expansion also includes manual sample extraction using the MagMax Viral\/Pathogen Nucleic Acid Isolation Kit as well as Applied Biosystems COVID-19 Interpretive Software.<\/span><\/p>\n<p style=\"margin-bottom:.0001pt\">&nbsp;<\/p>\n<p style=\"margin-bottom:.0001pt\"><span style=\"line-height:normal\"><a href=\"http:\/\/www.thermofisher.com\/covid19ceivd\">www.thermofisher.com\/covid19ceivd<\/a><\/span><\/p>\n<p style=\"margin-bottom:.0001pt\">&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Thermo Fisher Scientific, Waltham, Mass., announces that it has received the CE mark in the European Union for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.<\/p>\n","protected":false},"author":63103,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[434,449,435,436,1],"tags":[],"class_list":["post-5823","post","type-post","status-publish","format-standard","hentry","category-electronics","category-medical-devices","category-news","category-news-articles","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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