{"id":17037,"date":"2015-02-05T13:19:02","date_gmt":"2015-02-05T18:19:02","guid":{"rendered":"http:\/\/pmedicine.org\/epatients\/?p=17037"},"modified":"2016-08-06T21:53:14","modified_gmt":"2016-08-07T01:53:14","slug":"precision-medicine-lcsm-edition","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2015\/02\/precision-medicine-lcsm-edition.html","title":{"rendered":"e-Patient efforts on &#8220;precision medicine&#8221; #LCSM edition"},"content":{"rendered":"<p>SPM member <a title=\"Gray Connections\" href=\"http:\/\/grayconnections.net\/\" target=\"_blank\">Janet Freeman-Daily<\/a>, who&#8217;s an active voice in the <a title=\"#medx on Symplur\" href=\"http:\/\/www.symplur.com\/healthcare-hashtags\/medx-tweetchat\/\" target=\"_blank\">#MedX<\/a> and <a title=\"#LCSM on Symplur\" href=\"http:\/\/www.symplur.com\/healthcare-hashtags\/lcsm\/\" target=\"_blank\">#LCSM<\/a> communities, alerted us to <a title=\"Change.org petition on lab-created tests (LDTs)\" href=\"https:\/\/www.change.org\/p\/protect-patient-access-to-precision-medicine-tell-fda-to-withdraw-proposed-ldt-regulations\" target=\"_blank\"><strong>a petition on Change.org<\/strong><\/a> that speaks directly to the principles of precision medicine &#8211; <a title=\"White House precision medicine call\" href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2015\/01\/a-landmark-day-in-the-movement-patients-in-the-front-row.html\" target=\"_blank\">called for by the President in a White House event attended by our own Nick Dawson<\/a> &#8211; and keeping the regulatory environment from standing in the way of actually delivering that precision medicine.<\/p>\n<p>Quoting from the petition:<\/p>\n<blockquote><p>The FDA\u2019s proposed \u201c<a class=\"vt-p\" href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM416685.pdf\" target=\"_blank\" rel=\"nofollow\">Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)\u201d <\/a>attempts to regulate LDTs as if they were self-contained devices (such as stents) or commercial test kits.\u00a0 This won\u2019t work.\u00a0 Getting the best diagnostic and treatment outcomes from available specimens relies of the practice of medicine, which the FDA is not supposed to regulate.<\/p>\n<p>The proposed regulations state that once a companion test kit obtains FDA approval, any modification to the test components or any change in specimen type requires separate FDA approval before the LDT can be offered to patients.\u00a0 If no companion test exists for an oncogene, an LDT may offered to patients without obtaining FDA approval IF it is offered ONLY to patients in the same healthcare system as the laboratory that performs the test.<\/p>\n<p>The proposed regulations require laboratories to submit all cancer-related LDTs for registration and listing.\u00a0 In addition, LDTs for which a cleared or approved companion diagnostic exists (like BRAF-driven melanoma and ALK-driven NSCLC) must be submitted for financially prohibitive and lengthy premarket review.\u00a0 Many labs, including those in major cancer centers (which currently offer hundreds of LDTs), might not have the deep pockets or other resources to seek FDA approval for their LDTs and would have to pull LDTs from their list of patient services, or even have to close.\u00a0 This would impede not only access to potentially life-saving diagnostics, but impede innovation as well.<\/p><\/blockquote>\n<p>Hit the link in the first graf, head over to the Change.org site, and read the entire petition for yourself. Sign it, if you&#8217;re in favor of its principles.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>SPM member Janet Freeman-Daily, who&#8217;s an active voice in the #MedX and #LCSM communities, alerted us to a petition on Change.org that speaks directly to the principles of precision medicine [&hellip;]<\/p>\n","protected":false},"author":57,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":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":[2],"tags":[7491,7559,6295,82,8,2710,7555,7556,7557,169,5194,7558],"coauthors":[],"class_list":["post-17037","post","type-post","status-publish","format-standard","hentry","category-trendsprinciples","tag-epatient","tag-lcsm","tag-s4pm","tag-e-patient","tag-e-patients","tag-fda","tag-janet-freeman-daily","tag-lab-developed-tests","tag-ldts","tag-participatory-medicine","tag-research","tag-scientific-research"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>e-Patient efforts on &quot;precision medicine&quot; 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