{"id":249589,"date":"2026-07-22T18:30:08","date_gmt":"2026-07-22T18:30:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/us-pa\/249589\/"},"modified":"2026-07-22T18:30:08","modified_gmt":"2026-07-22T18:30:08","slug":"bethlehems-orasure-gets-fda-emergency-authorization-for-ebola-test","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us-pa\/249589\/","title":{"rendered":"Bethlehem\u2019s OraSure gets FDA emergency authorization for Ebola test"},"content":{"rendered":"<p>Bethlehem\u2019s <a href=\"https:\/\/lvb.com\/tag\/orasure-technologies\/\" class=\"st_tag internal_tag \" rel=\"tag nofollow noopener\" title=\"Posts tagged with OraSure Technologies\" target=\"_blank\">OraSure Technologies<\/a>, a developer of point-of-care and home diagnostic testing and sample collection technologies, has received\u00a0emergency\u00a0use\u00a0authorization from the U.S. Food and Drug\u00a0Administration for\u00a0its second generation\u00a0OraQuick\u00a0Ebola 2.0 Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid from individuals suspected to have had Ebola disease at the time of death.\u00a0\u00a0\n<\/p>\n<p>The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and\u00a0Ta\u00ef\u00a0Forest.\u00a0\n<\/p>\n<p>OraSure said in a release that the\u00a0OraQuick\u00a0Ebola Rapid Antigen Test originally received De Novo marketing authorization from the <a href=\"https:\/\/lvb.com\/tag\/fda\/\" class=\"st_tag internal_tag \" rel=\"tag nofollow noopener\" title=\"Posts tagged with FDA\" target=\"_blank\">FDA<\/a> in 2019, making it the first and only rapid antigen test to receive full authorization for the detection of\u00a0Ebola\u00a0virus.\u00a0\u00a0<\/p>\n<p>The second-generation test authorized by the FDA has increased sensitivity, new chemistry, and a more automated manufacturing process. It was developed in cooperation with the Biomedical Advanced Research and Development Authority under a contract granted in 2022.\u00a0\n<\/p>\n<p>\u201cWe are proud to advance a second-generation Ebola test at a time when the world is confronting a serious and evolving outbreak in <a href=\"https:\/\/lvb.com\/tag\/central-africa\/\" class=\"st_tag internal_tag \" rel=\"tag nofollow noopener\" title=\"Posts tagged with Central Africa\" target=\"_blank\">Central Africa<\/a>,\u201d said <a href=\"https:\/\/lvb.com\/tag\/carrie-eglinton-manner\/\" class=\"st_tag internal_tag \" rel=\"tag nofollow noopener\" title=\"Posts tagged with Carrie Eglinton Manner\" target=\"_blank\">Carrie Eglinton Manner<\/a>,\u00a0president and CEO of OraSure. \u201cThis outbreak is particularly challenging due to the Bundibugyo virus, which has no approved vaccine or targeted treatment, reinforcing the critical need for rapid, accurate diagnostics that can detect this virus and support timely containment efforts.\u201d\u00a0\n<\/p>\n<p>The current Ebola epidemic, centered in the Democratic Republic of the Congo with cases extending into neighboring Uganda, has already resulted in hundreds of deaths and prompted the <a href=\"https:\/\/lvb.com\/tag\/world-health-organization\/\" class=\"st_tag internal_tag \" rel=\"tag nofollow noopener\" title=\"Posts tagged with world health organization\" target=\"_blank\">World Health Organization<\/a> to declare a global public health emergency.\u00a0\u00a0<\/p>\n<p>The\u00a0company\u00a0said it\u00a0is ramping up production of the\u00a0OraQuick\u00a0Ebola 2.0 Rapid Antigen Test to meet potential demand.\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"Bethlehem\u2019s OraSure Technologies, a developer of point-of-care and home diagnostic testing and sample collection technologies, has received\u00a0emergency\u00a0use\u00a0authorization from&hellip;\n","protected":false},"author":2,"featured_media":249590,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[153,155,154,106765,106766,106767,17457,51543,9235],"class_list":["post-249589","post","type-post","status-publish","format-standard","has-post-thumbnail","category-bethlehem","tag-bethlehem","tag-bethlehem-headlines","tag-bethlehem-news","tag-carrie-eglinton-manner","tag-central-africa","tag-ebola-virus","tag-fda","tag-orasure-technologies","tag-world-health-organization"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts\/249589","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/comments?post=249589"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts\/249589\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/media\/249590"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/media?parent=249589"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/categories?post=249589"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/tags?post=249589"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}