{"id":33,"date":"2015-01-06T20:29:49","date_gmt":"2015-01-06T20:29:49","guid":{"rendered":"http:\/\/entrogen.com\/web3\/?page_id=33"},"modified":"2016-09-12T21:45:56","modified_gmt":"2016-09-12T21:45:56","slug":"ugt1a1-genotyping-kit","status":"publish","type":"page","link":"https:\/\/entrogen.com\/web3\/ugt1a1-genotyping-kit\/","title":{"rendered":"UGT1A1 Genotyping Kit"},"content":{"rendered":"[et_pb_section fullwidth=&#8221;on&#8221; specialty=&#8221;off&#8221;][et_pb_fullwidth_header admin_label=&#8221;Fullwidth Header&#8221; title=&#8221;UGT1A1*28 Genotyping Kit&#8221; background_layout=&#8221;dark&#8221; text_orientation=&#8221;left&#8221; module_class=&#8221;product-page-header&#8221; \/][\/et_pb_section][et_pb_section][et_pb_row][et_pb_column type=&#8221;2_3&#8243;][et_pb_text admin_label=&#8221;Text&#8221; background_layout=&#8221;light&#8221; text_orientation=&#8221;left&#8221;]\n<div class=\"content-middle\">\n<div class=\"node\">\n<div class=\"content\">\n<h4>Available Products<\/h4>\n<table class=\"products_table\" width=\"100%\" cellspacing=\"3\" cellpadding=\"0\" align=\"center\">\n<tbody>\n<tr>\n<th><strong>Product Name\/Description <\/strong><\/th>\n<th>\n<div align=\"center\"><strong>No. of Reactions* <\/strong><\/div>\n<\/th>\n<th width=\"20%\"><strong>Product Code <\/strong><\/th>\n<\/tr>\n<tr>\n<td>UGT1A1 Genotyping Kit<\/td>\n<td>\n<div align=\"center\">50<\/div>\n<\/td>\n<td>UGT-RT50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"bodyText\">\u00a0*Includes all controls.<\/p>\n<p>&nbsp;<\/p>\n<h5 class=\"bodyText\">Irinotecan Toxicity and UGT1A1 Genotype<\/h5>\n<p class=\"bodyText\">Uridine diphosphate-glucuronyl transferase 1A1 (UGT1A1) is an enzyme that catalyzes the glucuronidation of various compounds, including steroid hormones, bilirubin, as well as xenobiotics, such as irinotecan. This process converts these substances to more water-soluble compounds that can be eliminated from the body. A polymorphic variation in the promoter of UGT1A1 leads to decreased expression of UGT1A1, resulting in reduced glucuronidation of SN-38, the active metabolite of irinotecan. Patients with a (TA)7 repeat (UGT1A1*28) have a 12-50% increased risk of Grade 4 neutropenia or severe diarrhea.3,4 Individuals that are homozygous for UGT1A1*28 mutation, that is have two alleles with 7 TA repeats (7\/7 homozygous) also known as a Gilbert\u2019s syndrome, will have the most severe toxicity to irinotecan.<\/p>\n<p class=\"bodyText\">\n<h5 class=\"bodyText\">Testing Procedure and Analysis<\/h5>\n<p class=\"bodyText\">The UGT1A1 Genotyping Kit is a polymerase chain reaction (PCR)-based assay that uses allele-specific probes to identify the most common Irinotecan polymorphic variant. The testing procedure involves three (3) simple steps:<\/p>\n<ul>\n<li class=\"bodyText\">Isolation of DNA from whole blood<\/li>\n<li class=\"bodyText\">Amplification of regions of the UGT1A1 gene using allele-specific probes<\/li>\n<li class=\"bodyText\">Analysis using real-time PCR instrument software<\/li>\n<\/ul>\n<p class=\"bodyText\">This test can be completed in approximately 2 hours from isolation of DNA to test result.<\/p>\n<h5 class=\"bodyText\"><\/h5>\n<h5 class=\"bodyText\">Equipment and Materials<\/h5>\n<p class=\"bodyText\">The UGT1A1 Genotyping Kit requires a real-time PCR instrument. Columns and reagents for DNA isolation are not included.<\/p>\n<p class=\"bodyText\">\n<h5 class=\"bodyText\">Intended Use<\/h5>\n<p>The UGT1A1 Genotyping Kit is available for <strong>Research Use Only (RUO)<\/strong> in the United States and for<strong> In Vitro Diagnostic use (CE-IVD)<\/strong> in Europe.<\/p>\n<\/div>\n<div style=\"clear: both;\"><\/div>\n<\/div>\n<\/div>\n<p><!-- end content --><\/p>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243;][et_pb_text admin_label=&#8221;Text&#8221; background_layout=&#8221;light&#8221; text_orientation=&#8221;left&#8221;]\n<div id=\"sidebar-right\" class=\"sidebar\">\n<div id=\"block-panel\" class=\"block \">\n<div class=\"block-inner\">\n<h2 class=\"block-title\">Overview<\/h2>\n<div class=\"block-content\">\n<div class=\"block-content-inner\">\n<div class=\"field field-type-text field-field-overview\">\n<div class=\"field-items\">\n<div class=\"field-item odd\">\n<ul class=\"panel-list\">\n<li>Detects the most common UGT1A1*28 variant<\/li>\n<li>Can be performed under 2 hours<\/li>\n<li>Simple setup and interpretation<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><!-- \/block --><\/p>\n<div id=\"block-panel\" class=\"block \">\n<div class=\"block-inner\">\n<h2 class=\"block-title\">More Product Info<\/h2>\n<div class=\"block-content\">\n<div class=\"panel-item\">\n<p><a title=\"Product Information Request Form\" href=\"https:\/\/entrogen.com\/web3\/product-information-request-form\/\">Request Additional Information<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><!-- \/block --><\/p>\n<div id=\"block-panel\" class=\"block \">\n<div class=\"block-inner\">\n<h2 class=\"block-title\">Related Products<\/h2>\n<div class=\"block-content\">\n<div class=\"block-content-inner\">\n<ul class=\"panel-list\"><ul><\/ul><\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><!-- \/block --><\/p>\n<\/div>\n<div style=\"clear: both;\"><\/div>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]\n","protected":false},"excerpt":{"rendered":"<p><div class=\"et_pb_section et_pb_section_0 et_pb_with_background et_section_regular\" >\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div><div class=\"et_pb_row et_pb_row_0 et_pb_row_empty\">\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div> Available Products Product Name\/Description No. of Reactions* Product Code UGT1A1 Genotyping Kit 50 UGT-RT50 \u00a0*Includes all controls. &nbsp; Irinotecan Toxicity and UGT1A1 Genotype Uridine diphosphate-glucuronyl transferase 1A1 (UGT1A1) is an enzyme that catalyzes the glucuronidation of various compounds, including steroid hormones, bilirubin, as well as xenobiotics, such as irinotecan. This process converts these substances [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<div class=\"content-middle\">\r\n<div class=\"node\">\r\n<div class=\"content\">\r\n<h4>Available Products<\/h4>\r\n<table class=\"products_table\" width=\"100%\" cellspacing=\"3\" cellpadding=\"0\" align=\"center\">\r\n<tbody>\r\n<tr>\r\n<th><strong>Product Name\/Description <\/strong><\/th>\r\n<th>\r\n<div align=\"center\"><strong>No. of Tests <\/strong><\/div><\/th>\r\n<th width=\"20%\"><strong>Product Code <\/strong><\/th>\r\n<\/tr>\r\n<tr>\r\n<td>UGT1A1*28 Genotyping Reagents for Gel-Electrophoresis - RUO<\/td>\r\n<td>\r\n<div align=\"center\">50<\/div><\/td>\r\n<td>UG-G50<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<table border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\r\n<tbody>\r\n<tr>\r\n<td class=\"welcome\" align=\"justify\" width=\"550\">\r\n<p class=\"bodyText\"><em>This is a comprehensive predictive test available for assessing the risk of toxicity due to Irinotecan-based chemotherapy which was approved by FDA as the 1st line (with 5-FU and leucovorin) and 2nd line therapy for metastatic colon\/rectal cancer. It detects polymorphic variants of UGT1A1 that cause increase toxicity associated with Irinotecan.<\/em><\/p>\r\n<p class=\"bodyText\"><strong>FDA Guidance<\/strong>. Studies have identified a genetic variant of the UGT1A1 gene that is commonly associated with severe toxicity in cancer patients undergoing Irinotecan-based therapy. In 2005 FDA cleared a test for UGT1A1 that detects this genetic variant, helping physicians determine the appropriate dosage of the drug with minimum adverse effects.<\/p>\r\n<p class=\"bodyText\"><strong>Functional roles of UGT1A1<\/strong>. Uridine diphosphate-glucuronyl transferase 1A1 (UGT1A1) is an enzyme that catalyzes the glucuronidation of various compounds, including steroid hormones, bilirubin, as well as xenobiotics, such as irinotecan. This process converts these substances to more water-soluble compounds that can be eliminated from the body.<sup>1<\/sup> A polymorphic variation in the promoter of UGT1A1 leads to decreased expression of UGT1A1, resulting in reduced glucuronidation of SN-38, the active metabolite of irinotecan.<sup>2<\/sup> Patients with a (TA)<sub>7<\/sub> repeat (UGT1A1*28) have a 12-50% increased risk of Grade 4 neutropenia or severe diarrhea.<sup>3,4<\/sup> Individuals that are homozygous for UGT1A1*28 mutation, that is have two alleles with 7 TA repeats (7\/7 homozygous) also known as a Gilbert's syndrome, will have the most severe toxicity to irinotecan.<sup>5<\/sup><\/p>\r\n<p class=\"bodyText\">UGT1A1*28-associated risk of neutropenia:<\/p>\r\n\r\n<table class=\"products_table\" width=\"78%\">\r\n<tbody>\r\n<tr class=\"tbl_header\">\r\n<th scope=\"col\">\r\n<div align=\"center\">Patient Group<\/div><\/th>\r\n<th scope=\"col\" align=\"center\">\r\n<div align=\"center\">Prevalence<\/div><\/th>\r\n<th scope=\"col\" align=\"center\">\r\n<div align=\"center\">Risk of Neutropenia<\/div><\/th>\r\n<\/tr>\r\n<tr class=\"tbl_text\">\r\n<td>All patients<\/td>\r\n<td align=\"center\">-<\/td>\r\n<td align=\"center\">10 in 100<\/td>\r\n<\/tr>\r\n<tr class=\"tbl_text\">\r\n<td>Wild-type 6\/6<\/td>\r\n<td align=\"center\">50%<\/td>\r\n<td align=\"center\">0 in 100<\/td>\r\n<\/tr>\r\n<tr class=\"tbl_text\">\r\n<td>Heterozygous 6\/7-deficient<\/td>\r\n<td align=\"center\">40%<\/td>\r\n<td align=\"center\">12 in 100<\/td>\r\n<\/tr>\r\n<tr class=\"tbl_text\">\r\n<td>Homozygous 7\/7-deficient<\/td>\r\n<td align=\"center\">10%<\/td>\r\n<td align=\"center\">50 in 100<\/td>\r\n<\/tr>\r\n<tr bgcolor=\"#FFFFFF\">\r\n<td class=\"x-small_italic\" colspan=\"3\">Innocenti et al.,Pharmacol Ther. 2004 Jun;75(6):495-500<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<p class=\"bodyText\"><strong>Reporting<\/strong>. This assay tests for two polymorphic variations in the promoter region of UGT1A1: UGT1A1*1 (TA)<sub>6<\/sub> and UGT1A1*28 (TA)<sub>7<\/sub>.<\/p>\r\n\r\n<table class=\"products_table\" width=\"78%\">\r\n<tbody>\r\n<tr class=\"tbl_text\">\r\n<td class=\"tbl_header\">High Risk<\/td>\r\n<td align=\"center\">Homozygous UGT1A1*28 mutation<\/td>\r\n<\/tr>\r\n<tr class=\"tbl_text\">\r\n<td class=\"tbl_header\">Moderate Risk<\/td>\r\n<td align=\"center\">Heterozygous UGT1A1*28 mutation<\/td>\r\n<\/tr>\r\n<tr class=\"tbl_text\">\r\n<td class=\"tbl_header\">Low Risk<\/td>\r\n<td align=\"center\">No mutation<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<p class=\"bodyText\"><strong>Interpretation<\/strong>. Individuals in the High Risk and Moderate Risk groups carry a 50% and 12.5% risk of severe (Grade 4) neutropenia, respectively.<\/p>\r\n<p class=\"bodyText\"><strong>Other names for irinotecan drugs<\/strong>:\r\n\r\nCamptosar<sup>\u00ae<\/sup>, CPT-11<\/p>\r\n<p class=\"bodyText\"><\/p>\r\n\r\n<h4>Intended Use<\/h4>\r\nEntroGen\u2019s UGT1A1 Genotyping Kit is provided for <strong>research use only (RUO)<\/strong>. Not for use in diagnostic procedures.\r\n<p class=\"x-small_italic\"><strong>References<\/strong><\/p>\r\n\r\n<ol>\r\n\t<li class=\"x-small_italic\">Rouits et al., <em>Clin Cancer Res. <\/em>2004; 10:5151-5159<\/li>\r\n\t<li class=\"x-small_italic\">Iyer et al., <em>J Clin Invest. <\/em>1998; 101:847-854<\/li>\r\n\t<li class=\"x-small_italic\">Proceedings from FDA Clinical Pharmacology Subcommittee, November 3-4, 2004. (<a href=\"http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/04\/briefing\/2004-4079B1_03_Topic1-TabA.pdf\">http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/04\/briefing\/2004-4079B1_03_Topic1-TabA.pdf<\/a>)<\/li>\r\n\t<li class=\"x-small_italic\">Innocenti et al., <em>J Clin Oncol<\/em>. 2004; 22:1382-1388<\/li>\r\n\t<li class=\"x-small_italic\">Beutler et al., <em>Proc Natl Acad Sci USA. <\/em>1998; 95:8170-8174<\/li>\r\n<\/ol>\r\n<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<\/div>\r\n<div style=\"clear: both;\"><\/div>\r\n<\/div>\r\n<\/div>\r\n<!-- end content -->","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[],"tags":[],"class_list":["post-33","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/pages\/33","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/comments?post=33"}],"version-history":[{"count":14,"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/pages\/33\/revisions"}],"predecessor-version":[{"id":1490,"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/pages\/33\/revisions\/1490"}],"wp:attachment":[{"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/media?parent=33"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/categories?post=33"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/entrogen.com\/web3\/wp-json\/wp\/v2\/tags?post=33"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}