{"id":109997,"date":"2016-08-31T03:32:31","date_gmt":"2016-08-31T03:32:31","guid":{"rendered":"http:\/\/healthmedicinet.com\/i\/theranos-withdraws-new-zika-test-after-fda-inspection-wsj\/"},"modified":"2016-08-31T03:32:31","modified_gmt":"2016-08-31T03:32:31","slug":"theranos-withdraws-new-zika-test-after-fda-inspection-wsj","status":"publish","type":"post","link":"http:\/\/healthmedicinet.com\/i\/theranos-withdraws-new-zika-test-after-fda-inspection-wsj\/","title":{"rendered":"Theranos withdraws new Zika test after FDA inspection: WSJ"},"content":{"rendered":"<p><span id=\"article-text\"><br \/>\n<span id=\"midArticle_start\" \/><\/p>\n<p><span class=\"article-prime\"><\/p>\n<p><span class=\"articleLocatio\/spann\">Blood-testing firm Theranos Inc withdrew its request for emergency clearance of a Zika-virus blood test after U.S. regulators found the company did not include proper patient safeguards in a study on the test, The Wall Street Journal reported, citing people familiar with the matter.<\/span><\/p>\n<p><\/span><span id=\"midArticle_0\" \/><\/p>\n<p>Theranos was not immediately available for comment. <\/p>\n<p><span id=\"midArticle_1\" \/><\/p>\n<p>The diagnostic test for Zika can detect additional strains of the mosquito-borne virus from blood drops finger-pricked from patients, Theranos CEO Elizabeth Holmes said earlier this month. <\/p>\n<p><span id=\"midArticle_2\" \/><\/p>\n<p>The company said that it collected finger-stick blood samples from patients, including in the Dominican Republic, and ran the tests. <\/p>\n<p><span id=\"midArticle_3\" \/><\/p>\n<p>However, during an inspection by the Food and Drug Administration (FDA) earlier this month, regulators concluded that Theranos had collected some data supporting the accuracy of the Zika test without implementing a patient-safety protocol approved by an institutional review board, according to the people familiar with the matter, said the Journal. (on.wsj.com\/2c33MFf<\/a>)<\/p>\n<p><span id=\"midArticle_4\" \/><\/p>\n<p>            <span class=\"article-divide first-article-divide\" \/><\/p>\n<p>\u201cWe hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency,\u201d Theranos\u2019s vice president of regulatory, quality and clinical affairs Dave Wurtz told the Wall Street Journal. <\/p>\n<p><span id=\"midArticle_5\" \/><\/p>\n<p>In an email to Theranos investors on Saturday, the company said it plans to collect additional data requested by the FDA under properly reviewed protocols and resubmit the Zika application, the Journal reported. <\/p>\n<p><span id=\"midArticle_6\" \/><\/p>\n<p>            <span class=\"article-divide second-article-divide\" \/><\/p>\n<p>Theranos, who filed the request for emergency clearance to the FDA in the United States, did not contest the agency\u2019s findings and withdrew it, the Journal said, citing the sources.<\/p>\n<p><span id=\"midArticle_7\" \/><\/p>\n<p>The FDA\u2019s inspection in August was triggered by Theranos\u2019 request for \u201cemergency-use authorization\u201d to sell its new Zika test, a person familiar with the matter said, the Journal reported.<\/p>\n<p><span id=\"midArticle_8\" \/><\/p>\n<p \/><span id=\"midArticle_9\" \/><\/p>\n<p>            <span class=\"article-divide third-article-divide\" \/><\/p>\n<p \/><span id=\"midArticle_10\" \/><\/p>\n<p \/><span id=\"midArticle_11\" \/><\/p>\n<p \/><span id=\"midArticle_12\" \/><\/p>\n<p \/><span id=\"midArticle_13\" \/><\/p>\n<p> (Reporting by Vishaka George in Bengaluru; Editing by Andrew Hay)<\/p>\n<p><span id=\"midArticle_14\" \/><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Blood-testing firm Theranos Inc withdrew its request for emergency clearance of a Zika-virus blood test after U.S. regulators found the company did not include proper patient safeguards in a study on the test, The Wall Street Journal reported, citing people familiar with the matter. Theranos was not immediately available for comment. The diagnostic test for <a class=\"read-more-link\" href=\"http:\/\/healthmedicinet.com\/i\/theranos-withdraws-new-zika-test-after-fda-inspection-wsj\/\">Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-109997","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/posts\/109997","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/comments?post=109997"}],"version-history":[{"count":0,"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/posts\/109997\/revisions"}],"wp:attachment":[{"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/media?parent=109997"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/categories?post=109997"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/healthmedicinet.com\/i\/wp-json\/wp\/v2\/tags?post=109997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}