{"id":1451,"date":"2020-09-15T19:03:04","date_gmt":"2020-09-15T19:03:04","guid":{"rendered":"https:\/\/medicosnext.com\/?p=1451"},"modified":"2020-09-15T19:11:37","modified_gmt":"2020-09-15T19:11:37","slug":"roches-cobas-sars-cov-2-test-receives-fda-emergency-use-authorization","status":"publish","type":"post","link":"https:\/\/medicosnext.com\/?p=1451","title":{"rendered":"Roche\u2019s cobas SARS-CoV-2 test receives FDA Emergency Use Authorization"},"content":{"rendered":"<p><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-1453\" src=\"https:\/\/i0.wp.com\/medicosnext.com\/wp-content\/uploads\/2020\/09\/8800_hero.jpg?resize=618%2C123&#038;ssl=1\" alt=\"\" width=\"618\" height=\"123\" \/>Basel, 13 March 2020 \u2013 Roche, a global pioneer in pharmaceuticals and diagnostics, announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas\u00ae SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and\/or epidemiological criteria for testing. Hospitals and reference laboratories can run the test on Roche\u2019s fully automated <a href=\"https:\/\/diagnostics.roche.com\/us\/en\/products\/systems\/cobas-8800-system.html\">cobas\u00ae 6800\/8800 Systems<\/a>, which are widely available in the U.S. and around the world. The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.<\/p>\n<p>The widely available Roche\u2019s cobas 6800\/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results and offer improved operating efficiency, flexibility, and fastest time-to-results with the highest throughput with\u00a0up to 96 results in about three and a half hours and a total of 384 results for the\u00a0cobas 6800 System and 960 results for the cobas 8800 System in 8 hours. The test can be run simultaneously with other assays provided by Roche for use on the cobas 6800\/8800 Systems. The cobas SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. In the United States, the cobas SARS-CoV-2 is only for use under the FDA\u2019s Emergency Use Authorization.<\/p>\n<p><em>For more information about the tests and system, please visit\u00a0<\/em><a href=\"http:\/\/www.diagnostics.roche.com\/\"><em>www.diagnostics.roche.com<\/em><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Basel, 13 March 2020 \u2013 Roche, a global pioneer in pharmaceuticals and diagnostics, announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas\u00ae SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples &hellip;<\/p>\n","protected":false},"author":2,"featured_media":1452,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"advanced_seo_description":"","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[39,107],"tags":[109,108,110],"class_list":["post-1451","post","type-post","status-publish","format-standard","has-post-thumbnail","","category-feature","category-flash-news","tag-cobas","tag-covid","tag-roche"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/medicosnext.com\/wp-content\/uploads\/2020\/09\/cobas-8800_2880x1440-scaled.jpg?fit=2560%2C1248&ssl=1","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/medicosnext.com\/index.php?rest_route=\/wp\/v2\/posts\/1451","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medicosnext.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medicosnext.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medicosnext.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/medicosnext.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1451"}],"version-history":[{"count":0,"href":"https:\/\/medicosnext.com\/index.php?rest_route=\/wp\/v2\/posts\/1451\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medicosnext.com\/index.php?rest_route=\/wp\/v2\/media\/1452"}],"wp:attachment":[{"href":"https:\/\/medicosnext.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1451"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medicosnext.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1451"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medicosnext.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1451"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}