{"id":5144,"date":"2011-07-13T16:23:49","date_gmt":"2011-07-13T20:23:49","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=5144"},"modified":"2011-07-13T16:23:49","modified_gmt":"2011-07-13T20:23:49","slug":"fda-issues-draft-guidance-on-diagnostictherapy-companions","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=5144","title":{"rendered":"FDA Issues Draft Guidance on Diagnostic\/Therapy Companions"},"content":{"rendered":"<figure id=\"attachment_2886\" aria-describedby=\"caption-attachment-2886\" style=\"width: 200px\" class=\"wp-caption alignright\"><a href=\"http:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2011\/01\/MagnifyingGlass_TomomarusanWMC.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-2886\" title=\"MagnifyingGlass_TomomarusanWMC\" src=\"http:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2011\/01\/MagnifyingGlass_TomomarusanWMC.jpg\" alt=\"Magnifying Glass (Tomomarusan\/Wikimedia Commons)\" width=\"200\" height=\"300\" srcset=\"https:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2011\/01\/MagnifyingGlass_TomomarusanWMC.jpg 200w, https:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2011\/01\/MagnifyingGlass_TomomarusanWMC-100x150.jpg 100w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/><\/a><figcaption id=\"caption-attachment-2886\" class=\"wp-caption-text\">(Tomomarusan\/Wikimedia Commons)<\/figcaption><\/figure>\n<p>The U.S. <a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm262632.htm\">Food and Drug Administration<\/a> (FDA) issued a draft of guidance to encourage the development and review of diagnostics tests to help health care professionals determine if a patient should receive a particular drug therapy or its dosage. The agency is seeking public input on the <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm262292.htm\">draft guidance<\/a> for 60 days.<\/p>\n<p>The draft document aims to provide companies with FDA&#8217;s policy for reviewing a companion diagnostic and its corresponding therapy. A common type of companion diagnostic determines if a patient has a specific gene amplification or protein over-expression that can predict if a drug might benefit or harm the patient.<\/p>\n<p>An example is the FDA&#8217;s approval in 1998 of <a href=\"http:\/\/www.cancer.gov\/cancertopics\/druginfo\/trastuzumab\">Herceptin (trastuzumab)<\/a>, a breast cancer drug designed to target HER2 gene amplification or HER2 protein over-expression. The drug was approved with a companion test and today testing is routinely performed on women diagnosed with breast cancer to help health care professionals determine if the patient should receive Herceptin.<\/p>\n<p>The document clarifies the FDA&#8217;s <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm262292.htm#3\">definition of a companion diagnostic<\/a>, and recommends early engagement between the FDA and manufacturers so that the agency&#8217;s expectations are included in development plans. In addition, the guidance indicates FDA plan to conduct simultaneous reviews of a drug or biologic therapy and its corresponding companion diagnostic.<\/p>\n<p>The text identifies as well instances where FDA may approve a targeted medicine in the absence of a cleared or approved companion diagnostic. These cases will likely involve therapies intended to treat a serious or life-threatening disease or condition for which there are no available or satisfactory treatment and when the potential benefits outweigh the risks of not having a cleared or approved companion diagnostic. In these instances, the therapy could be approved first while the companion diagnostic may be approved or cleared later through the appropriate device submission process.<\/p>\n<p>Read more: <a href=\"http:\/\/sciencebusiness.technewslit.com\/?p=4760\">FDA Approves Genetic Test for Breast Cancer Treatment<\/a><\/p>\n<p style=\"text-align: center;\">*\u00a0\u00a0\u00a0\u00a0 *\u00a0\u00a0\u00a0\u00a0 *<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) issued a draft of guidance to encourage the development and review of diagnostics tests to help health care professionals determine if a patient should receive a particular drug therapy or its dosage. The agency is seeking public input on the draft guidance for 60 days. The draft document [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[31,22,64,77,27],"class_list":["post-5144","post","type-post","status-publish","format-standard","hentry","category-regulations","tag-biomedical","tag-fda","tag-life-sciences","tag-medical-device","tag-pharmaceuticals"],"_links":{"self":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/5144","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5144"}],"version-history":[{"count":5,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/5144\/revisions"}],"predecessor-version":[{"id":5149,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/5144\/revisions\/5149"}],"wp:attachment":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5144"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5144"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5144"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}