{"id":245351,"date":"2011-01-21T18:11:46","date_gmt":"2011-01-21T18:11:46","guid":{"rendered":"http:\/\/eugenesis.com\/laboratory-developed-tests-part-2\/"},"modified":"2011-01-21T18:11:46","modified_gmt":"2011-01-21T18:11:46","slug":"laboratory-developed-tests-part-2","status":"publish","type":"post","link":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/pathology\/laboratory-developed-tests-part-2.php","title":{"rendered":"Laboratory Developed Tests &#8211; Part 2"},"content":{"rendered":"<div><p><em>This is the second in a series of three posts on Laboratory Developed Tests (LDT).&nbsp; In this installment, I summarize developments in the past few years as the FDA eventually announced its intention to more actively regulate all LDTs.&nbsp; The first first post covered the definition of LDTs and the current state of regulatory oversight.&nbsp; In the next (and last) post, I discuss where to find comparative analysis reviews of LDTs and add a few thoughts on LDT policies for pathology departments, cancer centers, and healthcare systems.&nbsp;&nbsp; <\/em><\/p><p>The FDA recently decided to end its policy of enforcement discretion and more actively regulate LDTs.&nbsp; The agency has said it plans adopt a phased-in risk-based regulatory framework, but the details have yet to be established.&nbsp; A summary of key developments over the past few years is provided below:<\/p><ul><li>The FDA issued a revised <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm079148.htm\">draft guidance<\/a> in 2007 stating that In Vitro Diagnostic Multivariate Index Assays (IVDMIA) do <span>not<\/span> fall in the category of LDTs for which the agency had exercised enforcement discretion.&nbsp; This was a revision to a draft guidance issued in 2006.<\/li><li>The FDA cleared the first IVDMIA, MammaPrint&reg; (a breast cancer gene expression profiling test), in February of 2007.&nbsp; <\/li><li>The FDA later dropped its proposal to regulate IVDMIA as a subset of LDTs and announced plans to more actively regulate LDTs in general.<\/li><li>In April of 2008, the (Health and Human Services) Secretary&rsquo;s Advisory Committee on Genetics, Health, and Society (SACGHS), <a href=\"http:\/\/oba.od.nih.gov\/oba\/SACGHS\/reports\/SACGHS_oversight_report.pdf\">recommended<\/a> that \"FDA should address all laboratory tests in a manner that takes advantage of its current experience in evaluating laboratory tests\".&nbsp; <\/li><li>In an effort to get more input from laboratory professionals, treating physicians, patients, and industry, the FDA and the Center for Devices and Radiological Health (CDRH) held a public <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm079148.htm\">meeting<\/a> on the oversight of LDTs in July 2010.&nbsp; The subsequent public comment period originally scheduled to end on August 15, 2010 was extended to September 25, 2010.<\/li><li>In July 2010 the FDA and CMS signed a Memorandum of Understanding (MOU) stating that the agencies would work together to build the infrastructure and processes required to evaluate LDTs safety, efficacy, coverage, payment, etc.<\/li><\/ul><p>The FDA expects to begin providing details of the new regulatory structure a few months after the July 2010 meeting.&nbsp; At the time this post was written (December 30, 2010), few, if any, new details were available.<\/p><p>Several key questions remain:<\/p><p>What type of premarket evaluation will be required?&nbsp; Will companies and laboratories go through existing premarket evaluation [i.e. 510(k) clearance or premarket approval (PMA)] or a modified (or new) version of these requirements designed for LDTs?<\/p><p>The language in the MOU between the FDA and CMS included the words &ldquo;payment&rdquo; and coverage.&rdquo;&nbsp; But, will the agencies indeed work together to match reimbursement to the increased cost of premarket evaluation by the FDA?<\/p><p>What will the risk-based framework for evaluation of LDTs look like?&nbsp; The College of American Pathologists (CAP) proposed it own <a href=\"http:\/\/www.cap.org\/apps\/docs\/advocacy\/ldt\/oversight_model.pdf\">risk-based scheme<\/a> for LDTs.&nbsp; It consists of three categories: low, moderate, and high risk.&nbsp; The risk stratification is based on the likelihood of an incorrect result leading to serious morbidity\/mortality and whether the test methodology is well understood and\/or independently verifiable.&nbsp; Premarket review by the FDA would only be required for high risk LDTs.&nbsp; Moderate risk LDTs would undergo prior review and approval by CMS-deemed accreditors.&nbsp;<\/p><p>If you would like to follow developments in the regulation of &nbsp;LDTs, I recommend the following sources:<\/p><p><a href=\"http:\/\/www.genomeweb.com\/\">GenomeWeb<\/a> (take a look at Kirell Lakhman&rsquo;s blog, <a href=\"http:\/\/www.genomeweb.com\/newsletter\/sample\">The Sample<\/a>, and Turna Ray&rsquo;s articles in the <a href=\"http:\/\/www.genomeweb.com\/newsletter\/pharmacogenomics-reporter\">Pharmacogenomics Reporter<\/a>)<\/p><p><a href=\"http:\/\/myraqa.com\/\">Myraqa<\/a> (timely <a href=\"http:\/\/myraqa.com\/blog\">blog<\/a> posts by Mya Thomae and others)<\/p><p><a href=\"http:\/\/www.clinical-labs.org\/\">American Clinical Laboratory Association<\/a> (the ACLA and its president, Alan Mertz, have followed the evolution of LDT regulation closely, click <a href=\"http:\/\/www.clinical-labs.org\/issues\/fda\/index.shtml\">here<\/a> for more from their web site)<\/p><p><a href=\"http:\/\/www.cap.org\/apps\/cap.portal\">College of American Pathologists<\/a> (information on LDTs can be found under the <a href=\"http:\/\/www.cap.org\/apps\/cap.portal?_nfpb=true&amp;_pageLabel=advocacy\">Advocacy<\/a> tab)<\/p><p><em>&nbsp;<\/em><\/p><\/div><div><a href=\"http:\/\/feeds.feedburner.com\/~ff\/DigitalPathologyBlog?a=LpahK8PJGHc:jYAB9rlhnzE:yIl2AUoC8zA\"><img decoding=\"async\" src=\"http:\/\/eugenesis.com\/wp-content\/plugins\/wp-o-matic\/cache\/9f5d2_DigitalPathologyBlog?d=yIl2AUoC8zA\" border=\"0\" style=\"padding-left:10px; 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padding-right: 10px;\"><\/p>","protected":false},"excerpt":{"rendered":"<p>This is the second in a series of three posts on Laboratory Developed Tests (LDT).&nbsp; In this installment, I summarize developments in the past few years as the FDA eventually announced its intention to more actively regulate all LDTs.&nbsp; The &hellip; <a href=\"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/pathology\/laboratory-developed-tests-part-2.php\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":57,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"limit_modified_date":"","last_modified_date":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[577487],"tags":[],"class_list":["post-245351","post","type-post","status-publish","format-standard","hentry","category-pathology"],"modified_by":null,"_links":{"self":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/245351"}],"collection":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/users\/57"}],"replies":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/comments?post=245351"}],"version-history":[{"count":0,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/245351\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/media?parent=245351"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/categories?post=245351"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/tags?post=245351"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}