BETHLEHEM, Pa.- OraSure Technologies has secured Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for its second generation\u00a0OraQuick Ebola 2.0 Rapid Antigen Test.<\/p>\n
The single-use test\u00a0can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Ta\u00ef Forest. It can be used to test the blood of living patients or\u00a0oral fluids taken from those who are suspected to have died from Ebola.<\/p>\n
\u201cWe are proud to advance a second-generation Ebola test at a time when the world is confronting a serious and evolving outbreak in Central Africa,\u201d said Carrie Eglinton Manner, President and CEO of OraSure, in a news release.<\/p>\n
\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<\/p>\n
The FDA originally granted emergency use authorization for the OraQuick Ebola test in 2014 so healthcare workers could use it during an Ebola outbreak in West Africa that year. It was granted de novo authorization in 2019.<\/p>\n
The newer version of the test has improved analytical sensitivity, longer shelf life and a more automated manufacturing process.\u00a0<\/p>\n
The OraQuick Ebola Rapid Antigen Test is manufactured in Bethlehem, and OraSure said it planned to ramp up production to meet potential demand.<\/p>\n
The current Ebola outbreak is ravaging the Democratic Republic of the Congo (DRC) and Uganda.<\/p>\n
According to Congo\u2019s Ministry of Health, as of Monday, 2,473 cases have been recorded, and 999 people have died.\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"BETHLEHEM, Pa.- OraSure Technologies has secured Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for…\n","protected":false},"author":2,"featured_media":243099,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[119,121,120,106668,52689,106669],"class_list":["post-249343","post","type-post","status-publish","format-standard","has-post-thumbnail","category-allentown","tag-allentown","tag-allentown-headlines","tag-allentown-news","tag-emergency-use-authorization","tag-orasure","tag-u-s-food-and-drug-administration"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts\/249343","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=249343"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts\/249343\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/media\/243099"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/media?parent=249343"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/categories?post=249343"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/tags?post=249343"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}