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286/content/claudin/hcp/north-america/us/en/what-is-cldn","@type":"global/components/globalcomponents/global-nav/v3/global-nav/link","dc:title":"What is CLDN18.2?"}}"><span class="cmp-nav__menu--label">What is CLDN18.2? </span> 287 </a> 288 289 290 291 </div> 292 293 294 295 296 </li> 297 298 <li class="sublink-parentlink cmp-font-step--1 sublink-active-class megamenu--active nav-item-variant-medium"> 299 300 301 <div class="cmp-nav__menu--icon"> 302 <a href="/prepare-and-test-samples" class="megamenu-nomenu" target="_self" data-cmp-clickable data-cmp-data-layer="{"-064502f004":{"xdm:linkTarget":"_self","xdm:linkType":"internal","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/prepare-and-test-samples","@type":"global/components/globalcomponents/global-nav/v3/global-nav/link","dc:title":"Sample Preparation and Testing"}}"><span class="cmp-nav__menu--label">Sample Preparation and Testing </span> 303 </a> 304 305 306 307 </div> 308 309 310 311 312 </li> 313 314 <li class="sublink-parentlink cmp-font-step--1 nav-item-variant-large"> 315 316 317 <div class="cmp-nav__menu--icon"> 318 <a href="/stain-interpretation" class="megamenu-nomenu" target="_self" data-cmp-clickable data-cmp-data-layer="{"-3ce5a07668":{"xdm:linkTarget":"_self","xdm:linkType":"internal","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/stain-interpretation","@type":"global/components/globalcomponents/global-nav/v3/global-nav/link","dc:title":"Stain Interpretation"}}"><span class="cmp-nav__menu--label">Stain Interpretation </span> 319 </a> 320 321 322 323 </div> 324 325 326 327 328 </li> 329 330 <li class="sublink-parentlink cmp-font-step--1 nav-item-variant-medium"> 331 332 333 <div class="cmp-nav__menu--icon"> 334 <a href="/stain-gallery" class="megamenu-nomenu" target="_self" data-cmp-clickable data-cmp-data-layer="{"-925cd70045":{"xdm:linkTarget":"_self","xdm:linkType":"internal","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/stain-gallery","@type":"global/components/globalcomponents/global-nav/v3/global-nav/link","dc:title":"Stain Gallery and Quiz"}}"><span class="cmp-nav__menu--label">Stain Gallery and Quiz </span> 335 </a> 336 337 338 339 </div> 340 341 342 343 344 </li> 345 346 <li class="sublink-parentlink cmp-font-step--1 nav-item-variant-large"> 347 348 349 <div class="cmp-nav__menu--icon"> 350 <a href="/reporting-test-results" class="megamenu-nomenu" target="_self" data-cmp-clickable data-cmp-data-layer="{"-86e55ae6e6":{"xdm:linkTarget":"_self","xdm:linkType":"internal","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/reporting-test-results","@type":"global/components/globalcomponents/global-nav/v3/global-nav/link","dc:title":"Reporting Test Results"}}"><span class="cmp-nav__menu--label">Reporting Test Results </span> 351 </a> 352 353 354 355 </div> 356 357 358 359 360 </li> 361 362 <li class="sublink-parentlink cmp-font-step--1 nav-item-variant-medium"> 363 364 365 <div class="cmp-nav__menu--icon"> 366 <a href="/resources" class="megamenu-nomenu" target="_self" data-cmp-clickable data-cmp-data-layer="{"-321857b06e":{"xdm:linkTarget":"_self","xdm:linkType":"internal","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/resources","@type":"global/components/globalcomponents/global-nav/v3/global-nav/link","dc:title":"Resources"}}"><span class="cmp-nav__menu--label">Resources </span> 367 </a> 368 369 370 371 </div> 372 373 374 375 376 </li> 377 378 <li class="sublink-parentlink cmp-font-step--1 nav-item-variant-small"> 379 380 381 <div class="cmp-nav__menu--icon"> 382 <a href="/faqs" class="megamenu-nomenu" target="_self" data-cmp-clickable data-cmp-data-layer="{"-adc5388366":{"xdm:linkTarget":"_self","xdm:linkType":"internal","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/faqs","@type":"global/components/globalcomponents/global-nav/v3/global-nav/link","dc:title":"FAQs"}}"><span class="cmp-nav__menu--label">FAQs </span> 383 </a> 384 385 386 387 </div> 388 389 390 391 392 </li> 393 </ul> 394 <!-- Added for right nav links in hamburger start code--> 395 396 397 <div class="cmp-bottom-menu"> 398 399 400 401 402 403 404 </div> 405 <!-- Added for right nav links in hamburger End code--> 406 407 </div> 408 <div class="primary-nav__middlenav--gradient"></div> 409 </div> 410 411 <div class="nav primary-nav__rightnav search"> 412 413 414 415 <div class="nav above-brand-nav__rightnav cmp-mobile-show"> 416 417 418<div class="cmp-nav"> 419 420</div> 421 422 </div> 423 424 425 <div class="hamburger-container"> 426 <div class="hamburger-container__open">
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555 <div class="text bottom-space-s bold-styling step-3"> 556<div data-cmp-data-layer="{"text-417dbaa4f0":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-08T19:38:51Z","xdm:text":"<h2>This is a healthcare professional site</h2>\r\n"}}" id="text-417dbaa4f0" class="cmp-text"> 557 <h2>This is a healthcare professional site</h2> 558 559</div> 560 561 562 563</div> 564 565 </div> 566 </div> 567 <div class="modal-body text-center border-bottom-0 ast-padding__top--xxs ast-padding__inline--0 ast-color__text--extraDarkGray"> 568 <div class="ast__body-font ast__body--medium ast-color__text--extraDarkGray"> 569 <div class="text bottom-space-xl text-styling step-1 cmp-weight-styles regular"> 570<div data-cmp-data-layer="{"text-fcbbeb1c0e":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-09-21T09:16:51Z","xdm:text":"<p>The information contained on the site is intended for&nbsp;US healthcare professionals only. By selecting âOkayâ below, you verify that you are a licensed&nbsp;US healthcare professional.</p>\r\n"}}" id="text-fcbbeb1c0e" class="cmp-text"> 571 <p>The information contained on the site is intended for US healthcare professionals only. By selecting âOkayâ below, you verify that you are a licensed US healthcare professional.</p> 572 573</div> 574 575 576 577</div> 578 579 </div> 580 </div> 581 582 <div class="modal-footer border-top-0 justify-content-center ast-padding__inline--0"> 583 584 <div> 585 <div class="container responsivegrid"> 586 587 588 589 590 591 592 593 594 <div id="container-b4ff6e55e3" class="cmp-container"> 595 596 <div class="global-link cmp-global-link-primary cmp-horizantal-button"> 597 598 599 600 601 <ul> 602 <li> 603 604 605 606 607 608 609 610 611 <a href="javascript:void(0);" class="actionStoreCookie" data-modal-id="hcp" data-modal-link="#" data-cmp-data-layer="{"global-link-b4e0d527d0-headerlink-item0null":{ 612 "xdm:linkTarget" : "_self", 613 "xdm:linkType" : "internal", 614 "xdm:linkURL" : "#", 615 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 616 "dc:title" : "Okay" 617}}" target="_self" data-cmp-clickable> 618 619 <span>Okay</span> 620 621 </a> 622 623 624 625 626 627 628 629 630 631 </li> 632 633 <li> 634 635 636 637 638 639 640 641 642 <a href="javascript:void(0);" class="actionModalClose" data-modal-id="openpage" data-modal-link="#" data-cmp-data-layer="{"global-link-b4e0d527d0-headerlink-item1null":{ 643 "xdm:linkTarget" : "_self", 644 "xdm:linkType" : "internal", 645 "xdm:linkURL" : "#", 646 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 647 "dc:title" : "No" 648}}" target="_self" data-cmp-clickable> 649 650 <span>No</span> 651 652 </a> 653 654 655 656 657 658 659 660 661 662 </li> 663 </ul> 664</div> 665 666 667 </div> 668 669</div> 670 671 </div> 672 673 674 </div> 675 </div> 676 </div> 677 </div> 678 </div> 679 </div> 680</div> 681</div> 682<div class="gdsmodal aem-GridColumn aem-GridColumn--default--12"> 683 684 685 686 687 688 689 690<div class="modal_bg modalHide"> 691</div> 692<div class="modal exitmodalpopup ast-padding__inline--0 modalHide previewModel " id="redirect-1" data-cmp-data-layer="{"redirect-1":{"enableDescription":true,"enableButtons":true,"enableTitle":true,"xdm:linkURL":"","@type":"global/components/globalcomponents/gdsmodal/v1/gdsmodal","xdm:description":"","id":"redirect-1","repo:modifyDate":"2026-09-21T17:09:40Z","enableReferencesList":false}}" data-backdrop="static" data-keyboard="false" tabindex="0" role="dialog" aria-modal="true" aria-label="Leave your website alert message box is opened"> 693 <div class="u-container"> 694 <div class="modal-dialog modal-dialog-centered "> 695 <div class="modal-dialog" role="document"> 696 <div class="modal-content ast-information-card__container"> 697 <div class="ast-card__top ast-color__bg--surface"> 698 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 699 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 700 <div class="ast-color__bg--red ast-card__top-rec"></div> 701 </div> 702 703 704 <div class="ast-margin__inline--sm"> 705 706 <div class="modal-header justify-content-center border-bottom-0 ast-padding__inline--0"> 707 <div class="modal-title ast__title-font ast__title--large ast-font__weight--bold ast-color__text--red" id="redirect-1Heading">
708 <div class="text bottom-space-s bold-styling step-3"> 709<div data-cmp-data-layer="{"text-2b96d59886":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-08T20:16:52Z","xdm:text":"<h2>Thank you for visiting</h2>\r\n"}}" id="text-2b96d59886" class="cmp-text"> 710 <h2>Thank you for visiting</h2> 711 712</div> 713 714 715 716</div> 717 718 </div> 719 </div> 720 <div class="modal-body text-center border-bottom-0 ast-padding__top--xxs ast-padding__inline--0 ast-color__text--extraDarkGray"> 721 <div class="ast__body-font ast__body--medium ast-color__text--extraDarkGray"> 722 <div class="text bottom-space-xl text-styling step-1 cmp-weight-styles regular"> 723<div data-cmp-data-layer="{"text-a4247578e7":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-11T14:46:12Z","xdm:text":"<p>By clicking &quot;Continue,&quot; you will leave this site.</p>\r\n"}}" id="text-a4247578e7" class="cmp-text"> 724 <p>By clicking "Continue," you will leave this site.</p> 725 726</div> 727 728 729 730</div> 731 732 </div> 733 </div> 734 735 <div class="modal-footer border-top-0 justify-content-center ast-padding__inline--0"> 736 737 <div> 738 <div class="container responsivegrid"> 739 740 741 742 743 744 745 746 747 <div id="container-54679680fb" class="cmp-container"> 748 749 <div class="global-link cmp-global-link-primary cmp-horizantal-button"> 750 751 752 753 754 <ul> 755 <li> 756 757 758 759 760 761 762 763 764 <a href="javascript:void(0);" class="actionLinkRedirect" data-modal-link="https://www.astellas.com/en/privacy-policy" data-cmp-data-layer="{"global-link-de60aa70e3-headerlink-item0null":{ 765 "xdm:linkTarget" : "_blank", 766 "xdm:linkType" : "external", 767 "xdm:linkURL" : "https://www.astellas.com/en/privacy-policy", 768 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 769 "dc:title" : "Continue" 770}}" target="_blank" data-cmp-clickable> 771 772 <span>Continue</span> 773 774 775 </a> 776 777 778 779 780 781 782 </li> 783 784 <li> 785 786 787 788 789 790 791 792 793 <a href="javascript:void(0);" class="actionModalClose" data-modal-id="Cancel" data-modal-link="#" data-cmp-data-layer="{"global-link-de60aa70e3-headerlink-item1null":{ 794 "xdm:linkTarget" : "_self", 795 "xdm:linkType" : "internal", 796 "xdm:linkURL" : "#", 797 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 798 "dc:title" : "Cancel" 799}}" target="_self" data-cmp-clickable> 800 801 <span>Cancel</span> 802 803 </a> 804 805 806 807 808 809 810 811 812 813 </li> 814 </ul> 815</div> 816 817 818 </div> 819 820</div> 821 822 </div> 823 824 825 </div> 826 </div> 827 </div> 828 </div> 829 </div> 830 </div> 831</div> 832</div> 833<div class="gdsmodal aem-GridColumn aem-GridColumn--default--12"> 834 835 836 837 838 839 840 841<div class="modal_bg modalHide"> 842</div> 843<div class="modal exitmodalpopup ast-padding__inline--0 modalHide previewModel " id="redirect-2" data-cmp-data-layer="{"redirect-2":{"enableDescription":true,"enableButtons":true,"enableTitle":true,"xdm:linkURL":"","@type":"global/components/globalcomponents/gdsmodal/v1/gdsmodal","xdm:description":"","id":"redirect-2","repo:modifyDate":"2026-09-21T17:21:30Z","enableReferencesList":false}}" data-backdrop="static" data-keyboard="false" tabindex="0" role="dialog" aria-modal="true" aria-label="Leave your website alert message box is opened"> 844 <div class="u-container"> 845 <div class="modal-dialog modal-dialog-centered "> 846 <div class="modal-dialog" role="document"> 847 <div class="modal-content ast-information-card__container"> 848 <div class="ast-card__top ast-color__bg--surface"> 849 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 850 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 851 <div class="ast-color__bg--red ast-card__top-rec"></div> 852 </div> 853 854 855 <div class="ast-margin__inline--sm"> 856 857 <div class="modal-header justify-content-center border-bottom-0 ast-padding__inline--0"> 858 <div class="modal-title ast__title-font ast__title--large ast-font__weight--bold ast-color__text--red" id="redirect-2Heading">
859 <div class="text bottom-space-s bold-styling step-3"> 860<div data-cmp-data-layer="{"text-40c35d3100":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-08T20:16:52Z","xdm:text":"<h2>Thank you for visiting</h2>\r\n"}}" id="text-40c35d3100" class="cmp-text"> 861 <h2>Thank you for visiting</h2> 862 863</div> 864 865 866 867</div> 868 869 </div> 870 </div> 871 <div class="modal-body text-center border-bottom-0 ast-padding__top--xxs ast-padding__inline--0 ast-color__text--extraDarkGray"> 872 <div class="ast__body-font ast__body--medium ast-color__text--extraDarkGray"> 873 <div class="text bottom-space-xl text-styling step-1 cmp-weight-styles regular"> 874<div data-cmp-data-layer="{"text-f142fbc27f":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-11T14:46:12Z","xdm:text":"<p>By clicking &quot;Continue,&quot; you will leave this site.</p>\r\n"}}" id="text-f142fbc27f" class="cmp-text"> 875 <p>By clicking "Continue," you will leave this site.</p> 876 877</div> 878 879 880 881</div> 882 883 </div> 884 </div> 885 886 <div class="modal-footer border-top-0 justify-content-center ast-padding__inline--0"> 887 888 <div> 889 <div class="container responsivegrid"> 890 891 892 893 894 895 896 897 898 <div id="container-6b037f644f" class="cmp-container"> 899 900 <div class="global-link cmp-global-link-primary cmp-horizantal-button"> 901 902 903 904 905 <ul> 906 <li> 907 908 909 910 911 912 913 914 915 <a href="javascript:void(0);" class="actionLinkRedirect" data-modal-link="https://www.astellas.com/en/contact-us" data-cmp-data-layer="{"global-link-27fc94ad01-headerlink-item0null":{ 916 "xdm:linkTarget" : "_blank", 917 "xdm:linkType" : "external", 918 "xdm:linkURL" : "https://www.astellas.com/en/contact-us", 919 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 920 "dc:title" : "Continue" 921}}" target="_blank" data-cmp-clickable> 922 923 <span>Continue</span> 924 925 926 </a> 927 928 929 930 931 932 933 </li> 934 935 <li> 936 937 938 939 940 941 942 943 944 <a href="javascript:void(0);" class="actionModalClose" data-modal-id="Cancel" data-modal-link="#" data-cmp-data-layer="{"global-link-27fc94ad01-headerlink-item1null":{ 945 "xdm:linkTarget" : "_self", 946 "xdm:linkType" : "internal", 947 "xdm:linkURL" : "#", 948 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 949 "dc:title" : "Cancel" 950}}" target="_self" data-cmp-clickable> 951 952 <span>Cancel</span> 953 954 </a> 955 956 957 958 959 960 961 962 963 964 </li> 965 </ul> 966</div> 967 968 969 </div> 970 971</div> 972 973 </div> 974 975 976 </div> 977 </div> 978 </div> 979 </div> 980 </div> 981 </div> 982</div> 983</div> 984<div class="gdsmodal aem-GridColumn aem-GridColumn--default--12"> 985 986 987 988 989 990 991 992<div class="modal_bg modalHide"> 993</div> 994<div class="modal exitmodalpopup ast-padding__inline--0 modalHide previewModel " id="redirect-3" data-cmp-data-layer="{"redirect-3":{"enableDescription":true,"enableButtons":true,"enableTitle":true,"xdm:linkURL":"","@type":"global/components/globalcomponents/gdsmodal/v1/gdsmodal","xdm:description":"","id":"redirect-3","repo:modifyDate":"2026-09-21T17:09:56Z","enableReferencesList":false}}" data-backdrop="static" data-keyboard="false" tabindex="0" role="dialog" aria-modal="true" aria-label="Leave your website alert message box is opened"> 995 <div class="u-container"> 996 <div class="modal-dialog modal-dialog-centered "> 997 <div class="modal-dialog" role="document"> 998 <div class="modal-content ast-information-card__container"> 999 <div class="ast-card__top ast-color__bg--surface"> 1000 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 1001 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 1002 <div class="ast-color__bg--red ast-card__top-rec"></div> 1003 </div> 1004 1005 1006 <div class="ast-margin__inline--sm"> 1007 1008 <div class="modal-header justify-content-center border-bottom-0 ast-padding__inline--0"> 1009 <div class="modal-title ast__title-font ast__title--large ast-font__weight--bold ast-color__text--red" id="redirect-3Heading">
1010 <div class="text bottom-space-s bold-styling step-3"> 1011<div data-cmp-data-layer="{"text-2ec8317930":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-08T20:16:52Z","xdm:text":"<h2>Thank you for visiting</h2>\r\n"}}" id="text-2ec8317930" class="cmp-text"> 1012 <h2>Thank you for visiting</h2> 1013 1014</div> 1015 1016 1017 1018</div> 1019 1020 </div> 1021 </div> 1022 <div class="modal-body text-center border-bottom-0 ast-padding__top--xxs ast-padding__inline--0 ast-color__text--extraDarkGray"> 1023 <div class="ast__body-font ast__body--medium ast-color__text--extraDarkGray"> 1024 <div class="text bottom-space-xl text-styling step-1 cmp-weight-styles regular"> 1025<div data-cmp-data-layer="{"text-0d6e88d9b9":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-11T14:46:12Z","xdm:text":"<p>By clicking &quot;Continue,&quot; you will leave this site.</p>\r\n"}}" id="text-0d6e88d9b9" class="cmp-text"> 1026 <p>By clicking "Continue," you will leave this site.</p> 1027 1028</div> 1029 1030 1031 1032</div> 1033 1034 </div> 1035 </div> 1036 1037 <div class="modal-footer border-top-0 justify-content-center ast-padding__inline--0"> 1038 1039 <div> 1040 <div class="container responsivegrid"> 1041 1042 1043 1044 1045 1046 1047 1048 1049 <div id="container-a9f4ead22b" class="cmp-container"> 1050 1051 <div class="global-link cmp-global-link-primary cmp-horizantal-button"> 1052 1053 1054 1055 1056 <ul> 1057 <li> 1058 1059 1060 1061 1062 1063 1064 1065 1066 <a href="javascript:void(0);" class="actionLinkRedirect" data-modal-link="https://www.modernpathology.org/article/S0893-3952(24)00169-8/fulltext" data-cmp-data-layer="{"global-link-dcbeedf9d0-headerlink-item0null":{ 1067 "xdm:linkTarget" : "_blank", 1068 "xdm:linkType" : "external", 1069 "xdm:linkURL" : "https://www.modernpathology.org/article/S0893-3952(24)00169-8/fulltext", 1070 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 1071 "dc:title" : "Continue" 1072}}" target="_blank" data-cmp-clickable> 1073 1074 <span>Continue</span> 1075 1076 1077 </a> 1078 1079 1080 1081 1082 1083 1084 </li> 1085 1086 <li> 1087 1088 1089 1090 1091 1092 1093 1094 1095 <a href="javascript:void(0);" class="actionModalClose" data-modal-id="Cancel" data-modal-link="#" data-cmp-data-layer="{"global-link-dcbeedf9d0-headerlink-item1null":{ 1096 "xdm:linkTarget" : "_self", 1097 "xdm:linkType" : "internal", 1098 "xdm:linkURL" : "#", 1099 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 1100 "dc:title" : "Cancel" 1101}}" target="_self" data-cmp-clickable> 1102 1103 <span>Cancel</span> 1104 1105 </a> 1106 1107 1108 1109 1110 1111 1112 1113 1114 1115 </li> 1116 </ul> 1117</div> 1118 1119 1120 </div> 1121 1122</div> 1123 1124 </div> 1125 1126 1127 </div> 1128 </div> 1129 </div> 1130 </div> 1131 </div> 1132 </div> 1133</div> 1134</div> 1135<div class="gdsmodal aem-GridColumn aem-GridColumn--default--12"> 1136 1137 1138 1139 1140 1141 1142 1143<div class="modal_bg modalHide"> 1144</div> 1145<div class="modal exitmodalpopup ast-padding__inline--0 modalHide previewModel " id="redirect-4" data-cmp-data-layer="{"redirect-4":{"enableDescription":true,"enableButtons":true,"enableTitle":true,"xdm:linkURL":"","@type":"global/components/globalcomponents/gdsmodal/v1/gdsmodal","xdm:description":"","id":"redirect-4","repo:modifyDate":"2026-09-21T17:10:03Z","enableReferencesList":false}}" data-backdrop="static" data-keyboard="false" tabindex="0" role="dialog" aria-modal="true" aria-label="Leave your website alert message box is opened"> 1146 <div class="u-container"> 1147 <div class="modal-dialog modal-dialog-centered "> 1148 <div class="modal-dialog" role="document"> 1149 <div class="modal-content ast-information-card__container"> 1150 <div class="ast-card__top ast-color__bg--surface"> 1151 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 1152 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 1153 <div class="ast-color__bg--red ast-card__top-rec"></div> 1154 </div> 1155 1156 1157 <div class="ast-margin__inline--sm"> 1158 1159 <div class="modal-header justify-content-center border-bottom-0 ast-padding__inline--0"> 1160 <div class="modal-title ast__title-font ast__title--large ast-font__weight--bold ast-color__text--red" id="redirect-4Heading">
1161 <div class="text bottom-space-s bold-styling step-3"> 1162<div data-cmp-data-layer="{"text-257d22833e":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-08T20:16:52Z","xdm:text":"<h2>Thank you for visiting</h2>\r\n"}}" id="text-257d22833e" class="cmp-text"> 1163 <h2>Thank you for visiting</h2> 1164 1165</div> 1166 1167 1168 1169</div> 1170 1171 </div> 1172 </div> 1173 <div class="modal-body text-center border-bottom-0 ast-padding__top--xxs ast-padding__inline--0 ast-color__text--extraDarkGray"> 1174 <div class="ast__body-font ast__body--medium ast-color__text--extraDarkGray"> 1175 <div class="text bottom-space-xl text-styling step-1 cmp-weight-styles regular"> 1176<div data-cmp-data-layer="{"text-5e01efa91e":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-11T14:46:12Z","xdm:text":"<p>By clicking &quot;Continue,&quot; you will leave this site.</p>\r\n"}}" id="text-5e01efa91e" class="cmp-text"> 1177 <p>By clicking "Continue," you will leave this site.</p> 1178 1179</div> 1180 1181 1182 1183</div> 1184 1185 </div> 1186 </div> 1187 1188 <div class="modal-footer border-top-0 justify-content-center ast-padding__inline--0"> 1189 1190 <div> 1191 <div class="container responsivegrid"> 1192 1193 1194 1195 1196 1197 1198 1199 1200 <div id="container-755e66480f" class="cmp-container"> 1201 1202 <div class="global-link cmp-global-link-primary cmp-horizantal-button"> 1203 1204 1205 1206 1207 <ul> 1208 <li> 1209 1210 1211 1212 1213 1214 1215 1216 1217 <a href="javascript:void(0);" class="actionLinkRedirect" data-modal-link="https://link.springer.com/article/10.1007/s10120-024-01518-1" data-cmp-data-layer="{"global-link-b78a772f86-headerlink-item0null":{ 1218 "xdm:linkTarget" : "_blank", 1219 "xdm:linkType" : "external", 1220 "xdm:linkURL" : "https://link.springer.com/article/10.1007/s10120-024-01518-1", 1221 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 1222 "dc:title" : "Continue" 1223}}" target="_blank" data-cmp-clickable> 1224 1225 <span>Continue</span> 1226 1227 1228 </a> 1229 1230 1231 1232 1233 1234 1235 </li> 1236 1237 <li> 1238 1239 1240 1241 1242 1243 1244 1245 1246 <a href="javascript:void(0);" class="actionModalClose" data-modal-id="Cancel" data-modal-link="#" data-cmp-data-layer="{"global-link-b78a772f86-headerlink-item1null":{ 1247 "xdm:linkTarget" : "_self", 1248 "xdm:linkType" : "internal", 1249 "xdm:linkURL" : "#", 1250 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 1251 "dc:title" : "Cancel" 1252}}" target="_self" data-cmp-clickable> 1253 1254 <span>Cancel</span> 1255 1256 </a> 1257 1258 1259 1260 1261 1262 1263 1264 1265 1266 </li> 1267 </ul> 1268</div> 1269 1270 1271 </div> 1272 1273</div> 1274 1275 </div> 1276 1277 1278 </div> 1279 </div> 1280 </div> 1281 </div> 1282 </div> 1283 </div> 1284</div> 1285</div> 1286<div class="gdsmodal aem-GridColumn aem-GridColumn--default--12"> 1287 1288 1289 1290 1291 1292 1293 1294<div class="modal_bg modalHide"> 1295</div> 1296<div class="modal exitmodalpopup ast-padding__inline--0 modalHide previewModel " id="redirect-5" data-cmp-data-layer="{"redirect-5":{"enableDescription":true,"enableButtons":true,"enableTitle":true,"xdm:linkURL":"","@type":"global/components/globalcomponents/gdsmodal/v1/gdsmodal","xdm:description":"","id":"redirect-5","repo:modifyDate":"2026-09-21T17:10:11Z","enableReferencesList":false}}" data-backdrop="static" data-keyboard="false" tabindex="0" role="dialog" aria-modal="true" aria-label="Leave your website alert message box is opened"> 1297 <div class="u-container"> 1298 <div class="modal-dialog modal-dialog-centered "> 1299 <div class="modal-dialog" role="document"> 1300 <div class="modal-content ast-information-card__container"> 1301 <div class="ast-card__top ast-color__bg--surface"> 1302 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 1303 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 1304 <div class="ast-color__bg--red ast-card__top-rec"></div> 1305 </div> 1306 1307 1308 <div class="ast-margin__inline--sm"> 1309 1310 <div class="modal-header justify-content-center border-bottom-0 ast-padding__inline--0"> 1311 <div class="modal-title ast__title-font ast__title--large ast-font__weight--bold ast-color__text--red" id="redirect-5Heading">
1312 <div class="text bottom-space-s bold-styling step-3"> 1313<div data-cmp-data-layer="{"text-382cf36d1b":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-08T20:16:52Z","xdm:text":"<h2>Thank you for visiting</h2>\r\n"}}" id="text-382cf36d1b" class="cmp-text"> 1314 <h2>Thank you for visiting</h2> 1315 1316</div> 1317 1318 1319 1320</div> 1321 1322 </div> 1323 </div> 1324 <div class="modal-body text-center border-bottom-0 ast-padding__top--xxs ast-padding__inline--0 ast-color__text--extraDarkGray"> 1325 <div class="ast__body-font ast__body--medium ast-color__text--extraDarkGray"> 1326 <div class="text bottom-space-xl text-styling step-1 cmp-weight-styles regular"> 1327<div data-cmp-data-layer="{"text-92f41987e4":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-11T14:46:12Z","xdm:text":"<p>By clicking &quot;Continue,&quot; you will leave this site.</p>\r\n"}}" id="text-92f41987e4" class="cmp-text"> 1328 <p>By clicking "Continue," you will leave this site.</p> 1329 1330</div> 1331 1332 1333 1334</div> 1335 1336 </div> 1337 </div> 1338 1339 <div class="modal-footer border-top-0 justify-content-center ast-padding__inline--0"> 1340 1341 <div> 1342 <div class="container responsivegrid"> 1343 1344 1345 1346 1347 1348 1349 1350 1351 <div id="container-085d39dc3d" class="cmp-container"> 1352 1353 <div class="global-link cmp-global-link-primary cmp-horizantal-button"> 1354 1355 1356 1357 1358 <ul> 1359 <li> 1360 1361 1362 1363 1364 1365 1366 1367 1368 <a href="javascript:void(0);" class="actionLinkRedirect" data-modal-link="https://www.modernpathology.org/article/S0893-3952(25)00141-3/fulltext" data-cmp-data-layer="{"global-link-66de1b0fd5-headerlink-item0null":{ 1369 "xdm:linkTarget" : "_blank", 1370 "xdm:linkType" : "external", 1371 "xdm:linkURL" : "https://www.modernpathology.org/article/S0893-3952(25)00141-3/fulltext", 1372 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 1373 "dc:title" : "Continue" 1374}}" target="_blank" data-cmp-clickable> 1375 1376 <span>Continue</span> 1377 1378 1379 </a> 1380 1381 1382 1383 1384 1385 1386 </li> 1387 1388 <li> 1389 1390 1391 1392 1393 1394 1395 1396 1397 <a href="javascript:void(0);" class="actionModalClose" data-modal-id="Cancel" data-modal-link="#" data-cmp-data-layer="{"global-link-66de1b0fd5-headerlink-item1null":{ 1398 "xdm:linkTarget" : "_self", 1399 "xdm:linkType" : "internal", 1400 "xdm:linkURL" : "#", 1401 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 1402 "dc:title" : "Cancel" 1403}}" target="_self" data-cmp-clickable> 1404 1405 <span>Cancel</span> 1406 1407 </a> 1408 1409 1410 1411 1412 1413 1414 1415 1416 1417 </li> 1418 </ul> 1419</div> 1420 1421 1422 </div> 1423 1424</div> 1425 1426 </div> 1427 1428 1429 </div> 1430 </div> 1431 </div> 1432 </div> 1433 </div> 1434 </div> 1435</div> 1436</div> 1437<div class="gdsmodal aem-GridColumn aem-GridColumn--default--12"> 1438 1439 1440 1441 1442 1443 1444 1445<div class="modal_bg modalHide"> 1446</div> 1447<div class="modal exitmodalpopup ast-padding__inline--0 modalHide previewModel " id="redirect-6" data-cmp-data-layer="{"redirect-6":{"enableDescription":true,"enableButtons":true,"enableTitle":true,"xdm:linkURL":"","@type":"global/components/globalcomponents/gdsmodal/v1/gdsmodal","xdm:description":"","id":"redirect-6","repo:modifyDate":"2026-09-21T17:10:18Z","enableReferencesList":false}}" data-backdrop="static" data-keyboard="false" tabindex="0" role="dialog" aria-modal="true" aria-label="Leave your website alert message box is opened"> 1448 <div class="u-container"> 1449 <div class="modal-dialog modal-dialog-centered "> 1450 <div class="modal-dialog" role="document"> 1451 <div class="modal-content ast-information-card__container"> 1452 <div class="ast-card__top ast-color__bg--surface"> 1453 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 1454 <div class="ast-color__bg--darkRed ast-card__top-rec"></div> 1455 <div class="ast-color__bg--red ast-card__top-rec"></div> 1456 </div> 1457 1458 1459 <div class="ast-margin__inline--sm"> 1460 1461 <div class="modal-header justify-content-center border-bottom-0 ast-padding__inline--0"> 1462 <div class="modal-title ast__title-font ast__title--large ast-font__weight--bold ast-color__text--red" id="redirect-6Heading">
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class="cmp-teaser-content" id="teasercontentblock-cdc7d7f294"> 2094 <div class="tagcallout text"> 2095 <div class="cmp-tagcallout" id="tagcallout-9b67f7ded8" data-cmp-data-layer="{"tagcallout-9b67f7ded8":{"@type":"global/components/globalcomponents/tagcallout/v1/tagcallout","xdm:text":""}}"> 2096 <div class="text"> 2097 <div class="cmp-text"> 2098 2099 </div> 2100 </div> 2101 </div> 2102 2103 2104 2105</div> 2106 2107 2108 <div class="text cmp-teaser-content--title"> 2109 <div class="text bold-styling step-5 cmp-weight-styles bold cmp-element__colorcode--card-title"> 2110<div data-cmp-data-layer="{"text-ed27c790d2":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-05T17:52:07Z","xdm:text":"<h1>Preparing and testing for CLDN18.2</h1>\r\n"}}" id="text-ed27c790d2" class="cmp-text"> 2111 <h1>Preparing and testing for CLDN18.2</h1> 2112 2113</div> 2114 2115 2116 2117</div> 2118 2119 2120 </div> 2121 2122 2123 <div class="text cmp-teaser-content--description1"> 2124 2125 <div class="text bold-styling step-1 cmp-weight-styles semi-bold cmp-element__colorcode--primary-card-subtitle subtitle-styling"> 2126<div data-cmp-data-layer="{"text-72b70f300c":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T17:04:17Z","xdm:text":"<h3><span class=\"cmp-weight-styles semi-bold bold-styling step-1\">Learn more about testing for CLDN18.2, including the impact of preanalytical factors on staining, the importance of antibody selection, and the significance of reflexive CLDN18.2 testing upon diagnosis.<sup>1, 2</sup></span></h3>\r\n"}}" id="text-72b70f300c" class="cmp-text"> 2127 <h3><span class="cmp-weight-styles semi-bold bold-styling step-1">Learn more about testing for CLDN18.2, including the impact of preanalytical factors on staining, the importance of antibody selection, and the significance of reflexive CLDN18.2 testing upon diagnosis.<sup>1, 2</sup></span></h3> 2128 2129</div> 2130 2131 2132 2133</div> 2134 2135 2136 </div> 2137 2138 2139 2140 2141 2142 2143 2144 2145</div></div> 2146 2147 2148 2149 2150 <div class="cmp-hero-mediablock"> 2151 <div class="image cmp-hero-mediablock--img"> 2152 <div class="cmp-image"> 2153 <div class="image rounded-corner cmp-desktop cmp-border-radius--s"> 2154 2155 2156<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=%7B.width%7D&ts=1790348523612&dpr=off" data-asset-id="e86071e9-0fe5-4c33-8423-f02d72e8cd51" data-cmp-data-layer="{"":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:31:03Z","image":{"repo:id":"e86071e9-0fe5-4c33-8423-f02d72e8cd51","repo:modifyDate":"2026-09-25T15:02:03Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-hero-d.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 2157 2158 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&ts=1790348523612&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=400&ts=1790348523612&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=600&ts=1790348523612&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=800&ts=1790348523612&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=1000&ts=1790348523612&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=1200&ts=1790348523612&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=1400&ts=1790348523612&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=1800&ts=1790348523612&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-d?qlt=82&wid=2000&ts=1790348523612&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="5104" height="2400" alt="Laboratory technician handling tissue cassettes at an embedding workstation."/> 2159 2160 2161 2162</div> 2163 2164 2165 2166</div> 2167 2168 2169 <div class="image rounded-corner cmp-mobile cmp-border-radius--s"> 2170 2171 2172<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-m?qlt=82&wid=%7B.width%7D&ts=1790348525421&wid=600&dpr=off" data-asset-id="443c5295-f201-44e1-b7cf-e4987ef909e7" data-cmp-data-layer="{"":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:31:13Z","image":{"repo:id":"443c5295-f201-44e1-b7cf-e4987ef909e7","repo:modifyDate":"2026-09-25T15:02:05Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-hero-m.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 2173 2174 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-m?qlt=82&ts=1790348525421&wid=600&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-m?qlt=82&wid=400&ts=1790348525421&wid=600&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-hero-m?qlt=82&wid=600&ts=1790348525421&wid=600&dpr=off 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cassettes at an embedding workstation."/> 2175 2176 2177 2178</div> 2179 2180 2181 2182</div> 2183 2184 </div> 2185 </div> 2186 2187 </div> 2188 2189 </div></div>
2190<div class="anchor-links cmp-anchor-links-white-bg"> 2191 2192 2193 2194 2195 <div class="clshidden"> 2196 <label class="lblhdnmorelinklable">More</label> 2197 <label class="lblmorelinklabelicon">more_horiz</label> 2198 </div> 2199 <div class="cmp-anchorlink"> 2200 <div class="cmp-primary-nav primary-nav__more"> 2201 <div class="primary-nav-wrapper u-container" data-cmp-data-layer="{"anchor-links-c540f9bb35":{"enableLogo3":false,"enableLogo":true,"enableLogo2":false,"@type":"global/components/globalcomponents/global-nav/v1/global-nav/link","enableSearch":false,"enableSecondaryNav":false}}"> 2202 <div class="primary-nav"> 2203 <!-- commenting as image component is not needed in anchorlinks component 2204 <div class="logo-images" data-sly-test="true"> 2205 <div class="image" data-sly-test="true"> 2206 <div class="cmp-image"> 2207 <sly 2208 data-sly-resource="logoimage" /> 2209 2210 </div> 2211 </div> 2212 2213 <div class="image" data-sly-test="false"> 2214 <div class="cmp-image"> 2215 <sly 2216 data-sly-resource="logoimage2" /> 2217 2218 </div> 2219 </div> 2220 <div class="image" data-sly-test="false"> 2221 <div class="cmp-image"> 2222 <sly 2223 data-sly-resource="logoimage3" /> 2224 2225 </div> 2226 </div> 2227 </div> --> 2228 2229 2230 2231 <div class="primary-nav__middlenav"> 2232 <div class="cmp-nav navigation"> 2233 <ul class="menu"> 2234 <li> 2235 <div class="cmp-nav__menu--label"> 2236 <span>Jump to:</span> 2237 </div> 2238 </li> 2239 2240 2241 <li> 2242 2243 2244 <div class="cmp-nav__menu--icon"> 2245 2246 <a href="#why-ihc" target="_blank" data-cmp-clickable data-cmp-data-layer="{"anchor-links-31936debfb-headerlink-item0null":{ 2247 "xdm:linkTarget" : "_blank", 2248 "xdm:linkType" : "internal", 2249 "xdm:linkURL" : "#why-ihc", 2250 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 2251 "dc:title" : "Why IHC?" 2252}}"><span>Why IHC?</span></a> 2253 2254 2255 2256 </div> 2257 2258 2259 </li> 2260 2261 2262 2263 <li> 2264 2265 2266 <div class="cmp-nav__menu--icon"> 2267 2268 <a href="#preanalytics" target="_self" data-cmp-clickable data-cmp-data-layer="{"anchor-links-31936debfb-headerlink-item1null":{ 2269 "xdm:linkTarget" : "_self", 2270 "xdm:linkType" : "internal", 2271 "xdm:linkURL" : "#preanalytics", 2272 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 2273 "dc:title" : "Sample Preparation and Preanalytics" 2274}}"><span>Sample Preparation and Preanalytics</span></a> 2275 2276 2277 2278 </div> 2279 2280 2281 </li> 2282 2283 2284 2285 <li> 2286 2287 2288 <div class="cmp-nav__menu--icon"> 2289 2290 <a href="#ihc-testing" target="_self" data-cmp-clickable data-cmp-data-layer="{"anchor-links-31936debfb-headerlink-item2null":{ 2291 "xdm:linkTarget" : "_self", 2292 "xdm:linkType" : "internal", 2293 "xdm:linkURL" : "#ihc-testing", 2294 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 2295 "dc:title" : "IHC Testing" 2296}}"><span>IHC Testing</span></a> 2297 2298 2299 2300 </div> 2301 2302 2303 </li> 2304 2305 2306 2307 <li> 2308 2309 2310 <div class="cmp-nav__menu--icon"> 2311 2312 <a href="#proficiency-evaluations" target="_self" data-cmp-clickable data-cmp-data-layer="{"anchor-links-31936debfb-headerlink-item3null":{ 2313 "xdm:linkTarget" : "_self", 2314 "xdm:linkType" : "internal", 2315 "xdm:linkURL" : "#proficiency-evaluations", 2316 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 2317 "dc:title" : "Proficiency Evaluations" 2318}}"><span>Proficiency Evaluations</span></a> 2319 2320 2321 2322 </div> 2323 2324 2325 </li> 2326 2327 2328 2329 <li> 2330 2331 2332 <div class="cmp-nav__menu--icon"> 2333 2334 <a href="#reflexive-testing" target="_self" data-cmp-clickable data-cmp-data-layer="{"anchor-links-31936debfb-headerlink-item4null":{ 2335 "xdm:linkTarget" : "_self", 2336 "xdm:linkType" : "internal", 2337 "xdm:linkURL" : "#reflexive-testing", 2338 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 2339 "dc:title" : "Reflexive Testing" 2340}}"><span>Reflexive Testing</span></a> 2341 2342 2343 2344 </div> 2345 2346 2347 </li> 2348 2349 2350 </ul> 2351 2352 2353 </div> 2354 <div class="primary-nav__middlenav--gradient"></div> 2355 </div> 2356 <div class="nav primary-nav__rightnav search"> 2357 <div class="primary-nav__rightnav--label"> 2358 Jump to: 2359 </div> 2360 2361 <div class="hamburger-container"> 2362 <div class="hamburger-container__open" data-cmp-data-layer="{"anchor-links-31936debfb-anchor-links":{ 2363 "@type" : "global/components/globalcomponents/global-nav/v1/global-nav/link/dropdown", 2364 "dc:title" : "Open anchor link menu" 2365}}">
2366 <span> 2367 Open anchor link menu 2368 </span> 2369 <span translate="no" aria-hidden="true" class="material-symbols-rounded notranslate"> 2370 keyboard_arrow_down 2371 </span> 2372 </div> 2373 <div class="hamburger-container__close"> 2374 <span> 2375 Close anchor link menu 2376 </span> 2377 <span translate="no" aria-hidden="true" class="material-symbols-rounded notranslate"> 2378 keyboard_arrow_up 2379 </span> 2380 </div> 2381 </div> 2382 </div> 2383 2384 2385 </div> 2386 </div> 2387 2388 </div> 2389 </div></div> 2390 2391 2392 </div> 2393 2394 2395</section></div> 2396<div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l"> 2397<section style=";"> 2398 2399 2400 2401 2402 2403 2404 2405 2406 2407 <div id="container-b84eaa4371" class="cmp-container"> 2408 2409 <div class="cardset"> 2410 <div class="cmp-cardset single-card" data-cmp-data-layer="{"cardset-d18737a210":{"dc:description":"","repo:modifyDate":"2026-03-04T17:19:09Z","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/prepare-and-test-samples","@type":"global/components/globalcomponents/cardset/v1/cardset","dc:title":""}}"> 2411 <div class="card teaser bottom-space-l card-secondary-dark cmp-teaser-content--dark"> 2412 2413 2414 2415 2416 2417 2418 2419 2420 2421<input type="hidden" name="resourcePath" id="resourcePath" value="/content/claudin/hcp/north-america/us/en/prepare-and-test-samples"/> 2422<input type="hidden" name="type" id="type"/> 2423<input type="hidden" name="subtype" id="subtype"/> 2424<input type="hidden" name="channel" id="channel"/> 2425<input type="hidden" name="seatavailability" id="seatavailability"/> 2426<input type="hidden" name="seperator" id="eventDateSep"/> 2427<input type="hidden" name="jobcodeDetail" id="jobcodeDetail"/> 2428<!-- Card starts here --> 2429 2430<div class="cmp-teaser" id="why-ihc" data-cmp-data-layer="{"why-ihc":{"@type":"/apps/global/components/globalcomponents/card/v1/card","repo:modifyDate":"2026-08-24T21:18:26Z"}}" data-video-card="false" data-video-has-transcript="false" data-video-plain-transcript="false" data-cmp-typechecked="false" data-cmp-subtypechecked="false" data-cmp-channelchecked="false" data-cmp-seatavailabilitychecked="false" data-cmp-Datechecked="false" data-cmp-Jobcodechecked="false"> 2431 <!-- image text --> 2432 2433 2434 2435 2436 2437 2438 <!-- Load when carousel link is not enabled --> 2439 <div class="cmp-teaser__container no-image no-referencelist"> 2440 2441 <div class="cmp-teaser__content__wrapper"> 2442 <!-- Content--> 2443 <div class="cmp-teaser__content"> 2444 <!--tags--> 2445 2446 2447 2448 2449 <!-- Search Tags for Card --> 2450 2451 2452 <!--kicker--> 2453 2454 2455 2456 2457 <!--title--> 2458 <div class="cmp-card__content__wrapper"> 2459 2460 2461 <!-- Time & Date from comp dialog--> 2462 2463 <!-- Time & Date from page Properties--> 2464 2465 <!-- Start & End Date from Response--> 2466 2467 <!--description--> 2468 2469 </div> 2470 2471 <div class="text bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 2472<div data-cmp-data-layer="{"text-e02d55b9cb":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-09-11T15:25:41Z","xdm:text":"<h2><b>IHC testing is the only clinically validated method to detect CLDN18.2 expression in G/GEJ adenocarcinoma.<sup>1-3</sup> Other methods, including whole-transcriptome sequencing and liquid biopsy, while useful in other contexts, cannot directly evaluate protein expression or localization and are not suitable for assessing CLDN18.2 positivity in clinical practice.<sup>4,5</sup></b></h2>\n"}}" id="text-e02d55b9cb" class="cmp-text"> 2473 <h2><b>IHC testing is the only clinically validated method to detect CLDN18.2 expression in G/GEJ adenocarcinoma.<sup>1-3</sup> Other methods, including whole-transcriptome sequencing and liquid biopsy, while useful in other contexts, cannot directly evaluate protein expression or localization and are not suitable for assessing CLDN18.2 positivity in clinical practice.<sup>4,5</sup></b></h2> 2474 2475</div> 2476 2477 2478 2479</div> 2480 2481 2482 2483 2484 <!-- Container --> 2485 2486 </div> 2487 <!-- Global Link Component--> 2488 2489 </div> 2490 </div> 2491 <!-- Card Reference Component--> 2492 2493 2494</div></div> 2495 2496 2497 2498 </div> 2499</div>
2500<div class="text bottom-space-m bold-styling step-4 cmp-weight-styles bold cmp-element__colorcode--page-title"> 2501<div data-cmp-data-layer="{"text-29439a6058":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-05-12T20:20:27Z","xdm:text":"<h2>IHC testing: Using CLDN18 antibodies to detect CLDN18.2 in G/GEJ tumor samples</h2>"}}" id="text-29439a6058" class="cmp-text"> 2502 <h2>IHC testing: Using CLDN18 antibodies to detect CLDN18.2 in G/GEJ tumor samples</h2> 2503</div> 2504 2505 2506 2507</div> 2508<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2509<div data-cmp-data-layer="{"text-364953f0f2":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T17:20:39Z","xdm:text":"<p>CLDN18 antibodies can identify both CLDN18 isoformsâCLDN18.1 and CLDN18.2; however, when evaluating G/GEJ tumor tissue, <span class=\"cmp-weight-styles bold\">staining can be attributed to the presence of CLDN18.2 only, because<sup>3</sup>:</span></p>"}}" id="text-364953f0f2" class="cmp-text"> 2510 <p>CLDN18 antibodies can identify both CLDN18 isoformsâCLDN18.1 and CLDN18.2; however, when evaluating G/GEJ tumor tissue, <span class="cmp-weight-styles bold">staining can be attributed to the presence of CLDN18.2 only, because<sup>3</sup>:</span></p> 2511</div> 2512 2513 2514 2515</div> 2516<div class="text bottom-space-m text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2517<div data-cmp-data-layer="{"text-a0792b557b":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T17:21:05Z","xdm:text":"<ul>\n<li>CLDN18.1 is the dominant isoform expressed in normal and malignant lung tissue, and its expression is negligible or absent in G/GEJ cancers<sup>3</sup></li>\n<li>CLDN18.2 is normally expressed in gastric epithelium, and expression is often <span class=\"cmp-weight-styles bold\">retained in malignant gastric tissue</span><sup>3</sup></li>\n</ul>"}}" id="text-a0792b557b" class="cmp-text"> 2518 <ul><li>CLDN18.1 is the dominant isoform expressed in normal and malignant lung tissue, and its expression is negligible or absent in G/GEJ cancers<sup>3</sup></li><li>CLDN18.2 is normally expressed in gastric epithelium, and expression is often <span class="cmp-weight-styles bold">retained in malignant gastric tissue</span><sup>3</sup></li></ul> 2519</div> 2520 2521 2522 2523</div> 2524 2525 2526 </div> 2527 2528 2529</section></div> 2530<div class="container responsivegrid"> 2531 2532 2533 2534 2535 2536 2537 2538 2539 <div id="container-3f9ae76eed" class="cmp-container" style="background:#F5F5F5;"> 2540 2541 <div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l top-padding-l"> 2542<section style=";"> 2543 2544 2545 2546 2547 2548 2549 2550 2551 2552 <div id="container-273f554061" class="cmp-container"> 2553 2554 <div class="text bottom-space-m bold-styling step-4 cmp-weight-styles bold cmp-element__colorcode--page-title"> 2555<div data-cmp-data-layer="{"preanalytics":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-24T21:14:06Z","xdm:text":"<h2>Sample preparation and preanalytics</h2>\r\n"}}" id="preanalytics" class="cmp-text"> 2556 <h2>Sample preparation and preanalytics</h2> 2557 2558</div> 2559 2560 2561 2562</div> 2563<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2564<div data-cmp-data-layer="{"text-961239e51c":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-05T13:38:04Z","xdm:text":"<p>Appropriate specimen handling and preparation are essential to ensure the accuracy of biomarker results.<sup>1</sup></p>\r\n"}}" id="text-961239e51c" class="cmp-text"> 2565 <p>Appropriate specimen handling and preparation are essential to ensure the accuracy of biomarker results.<sup>1</sup></p> 2566 2567</div> 2568 2569 2570 2571</div>
2572<div class="text bottom-space-xs bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--primary-page-subtitle"> 2573<div data-cmp-data-layer="{"text-87a304db6f":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-06T14:40:26Z","xdm:text":"<h2>Sample preparation</h2>\r\n"}}" id="text-87a304db6f" class="cmp-text"> 2574 <h2>Sample preparation</h2> 2575 2576</div> 2577 2578 2579 2580</div> 2581<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2582<div data-cmp-data-layer="{"text-a125ff3fde":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-06T14:41:17Z","xdm:text":"<p>Guidelines recommend daily tissue processor maintenance per the manufacturer recommendations and rigorous quality maintenance of processor fluids, including formalin pH/purity and water contamination of alcohols.<sup>1</sup></p>\r\n"}}" id="text-a125ff3fde" class="cmp-text"> 2583 <p>Guidelines recommend daily tissue processor maintenance per the manufacturer recommendations and rigorous quality maintenance of processor fluids, including formalin pH/purity and water contamination of alcohols.<sup>1</sup></p> 2584 2585</div> 2586 2587 2588 2589</div> 2590<div class="separator bottom-space-s top-space-s cmp-remove-margin-seperator cmp-separator--primary__mid"><div id="separator-f9ff730af6" class="cmp-separator"> 2591 <hr class="cmp-separator__horizontal-rule"/> 2592</div> 2593</div> 2594<div class="text bottom-space-xs top-space-m bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--primary-page-subtitle"> 2595<div data-cmp-data-layer="{"text-7fcf71e970":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-06T15:10:27Z","xdm:text":"<h2>Cold ischemic time</h2>\r\n"}}" id="text-7fcf71e970" class="cmp-text"> 2596 <h2>Cold ischemic time</h2> 2597 2598</div> 2599 2600 2601 2602</div> 2603<div class="text text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2604<div data-cmp-data-layer="{"text-dba7b18b2b":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-16T19:24:05Z","xdm:text":"<p>Cold ischemic time should be limited to â¤60 minutes according to current guidelines.<sup>1</sup></p>\r\n"}}" id="text-dba7b18b2b" class="cmp-text"> 2605 <p>Cold ischemic time should be limited to â¤60 minutes according to current guidelines.<sup>1</sup></p> 2606 2607</div> 2608 2609 2610 2611</div> 2612<div class="separator bottom-space-xl top-space-xl cmp-remove-margin-seperator cmp-separator--primary__mid"><div id="separator-12aa171ac9" class="cmp-separator"> 2613 <hr class="cmp-separator__horizontal-rule"/> 2614</div> 2615</div> 2616<div class="text bottom-space-xs bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--primary-page-subtitle"> 2617<div data-cmp-data-layer="{"text-d60df238ea":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-16T19:24:14Z","xdm:text":"<h2>Fixation</h2>\r\n"}}" id="text-d60df238ea" class="cmp-text"> 2618 <h2>Fixation</h2> 2619 2620</div> 2621 2622 2623 2624</div> 2625<div class="text text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2626<div data-cmp-data-layer="{"text-60d7bd61e2":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-12T21:27:39Z","xdm:text":"<p>Guidelines provide recommendations regarding dimensions and duration involved in sample fixation.<sup>1</sup></p>\r\n"}}" id="text-60d7bd61e2" class="cmp-text"> 2627 <p>Guidelines provide recommendations regarding dimensions and duration involved in sample fixation.<sup>1</sup></p> 2628 2629</div> 2630 2631 2632 2633</div> 2634<div class="columncontainer responsivegrid"> 2635 <div id="columncontainer-089581285c" class="cmp-columncontainer 2636 cmp-columncontainer--2col-2_1 cmp-columncontainer--spcol-1 2637 2638 "> 2639 2640 2641 <div class="cmp-columncontainer-item"> 2642 2643 2644<div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> 2645 2646 <div class="illustrationset aem-GridColumn aem-GridColumn--default--12"> 2647 2648 2649 2650 <div class="cmp-illustration" data-cmp-data-layer="{"illustrationset-55ad9c9a75":{"dc:description":"","repo:modifyDate":"2026-03-06T15:15:44Z","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/prepare-and-test-samples","@type":"global/components/globalcomponents/illustrationset/v1/illustrationset","dc:title":""}}"> 2651 <div class="illustration-container card teaser xl-size cmp-radius-image cmp-vertical-content cmp-remove-box-shadow cmp-remove-background remove-wrapper-padding text-styling step-0"> 2652 2653 2654 2655 2656 2657 2658 2659 2660<div class="illustration-container__imgwrapper"> 2661 2662 2663 2664 2665 2666<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=%7B.width%7D&ts=1790348524882&$transperant$&dpr=off" data-asset-id="1b0031db-b621-4aa7-b670-1de5c347aaed" id="illustration-container-9dc3b1df51-image" data-cmp-data-layer="{"illustration-container-9dc3b1df51-image":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:31:29Z","xdm:linkURL":"/prepare-and-test-samples","image":{"repo:id":"1b0031db-b621-4aa7-b670-1de5c347aaed","repo:modifyDate":"2026-09-25T15:02:04Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-icon-ruler-d.png"}}}" data-cmp-hook-image="imageV5" class="cmp-image" itemscope itemtype="http://schema.org/ImageObject"> 2667 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&ts=1790348524882&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=400&ts=1790348524882&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=600&ts=1790348524882&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=800&ts=1790348524882&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=1000&ts=1790348524882&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=1200&ts=1790348524882&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=1400&ts=1790348524882&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=1800&ts=1790348524882&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-ruler-d?qlt=82&wid=2000&ts=1790348524882&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="528" height="528" alt/> 2668 2669 2670</div> 2671 2672 2673 2674 2675 2676 2677 <!-- Code embed Component--> 2678</div> 2679 2680<div class="illustration-container__content" id="illustration-container-9dc3b1df51" data-cmp-data-layer="{"illustration-container-9dc3b1df51":{"@type":"/apps/global/components/globalcomponents/illustration-container/v1/illustration-container","repo:modifyDate":"2026-09-04T01:31:29Z","dc:title":"<h4><span class=\"cmp-weight-styles bold\">Key dimensions<sup>1</sup></span></h4>\r\n","dc:description":"<ul><li>Tissue should be completely submerged in fixative</li><li>Ensure a fixative volume-to-tissue mass ratio of no less than 4:1, with an optimal ratio of 10:1</li></ul>\r\n"}}"> 2681 2682 2683 2684
2685 <!--jobcode--> 2686 2687 <!--kicker--> 2688 2689 2690 <div class="illustration-container__content--title " aria-label="<h4><span class="cmp-weight-styles bold">Key dimensions<sup>1</sup></span></h4> 2691"><span><h4><span class="cmp-weight-styles bold">Key dimensions<sup>1</sup></span></h4> 2692</span></div> 2693 2694 2695 <!-- Time & Date from comp dialog--> 2696 2697 <!-- Time & Date from page Properties--> 2698 2699 2700 <div class="illustration-container__content--description "> 2701 <p><ul><li>Tissue should be completely submerged in fixative</li><li>Ensure a fixative volume-to-tissue mass ratio of no less than 4:1, with an optimal ratio of 10:1</li></ul> 2702</p> 2703 </div> 2704 2705 2706 2707 2708 <!-- Card Reference Component--> 2709 2710</div></div> 2711 2712 2713 2714 2715 </div> 2716</div> 2717 2718 2719</div> 2720</div> 2721 2722 2723 <div class="cmp-columncontainer-item"> 2724 2725 2726<div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> 2727 2728 <div class="illustrationset aem-GridColumn aem-GridColumn--default--12"> 2729 2730 2731 2732 <div class="cmp-illustration" data-cmp-data-layer="{"illustrationset-a14e9de25a":{"dc:description":"","repo:modifyDate":"2026-03-06T15:15:44Z","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/prepare-and-test-samples","@type":"global/components/globalcomponents/illustrationset/v1/illustrationset","dc:title":""}}"> 2733 <div class="illustration-container card teaser xl-size cmp-radius-image cmp-vertical-content cmp-remove-box-shadow cmp-remove-background remove-wrapper-padding text-styling step-0"> 2734 2735 2736 2737 2738 2739 2740 2741 2742<div class="illustration-container__imgwrapper"> 2743 2744 2745 2746 2747 2748<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=%7B.width%7D&ts=1790348520123&$transperant$&dpr=off" data-asset-id="a1ee6f0e-b77a-4d38-8f21-dbca52b711bd" id="illustration-container-ae99000cdc-image" data-cmp-data-layer="{"illustration-container-ae99000cdc-image":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:31:39Z","xdm:linkURL":"/prepare-and-test-samples","image":{"repo:id":"a1ee6f0e-b77a-4d38-8f21-dbca52b711bd","repo:modifyDate":"2026-09-25T15:02:00Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-icon-clock-d.png"}}}" data-cmp-hook-image="imageV5" class="cmp-image" itemscope itemtype="http://schema.org/ImageObject"> 2749 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&ts=1790348520123&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=400&ts=1790348520123&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=600&ts=1790348520123&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=800&ts=1790348520123&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=1000&ts=1790348520123&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=1200&ts=1790348520123&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=1400&ts=1790348520123&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=1800&ts=1790348520123&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-icon-clock-d?qlt=82&wid=2000&ts=1790348520123&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="528" height="528" alt/> 2750 2751 2752</div> 2753 2754 2755 2756 2757 2758 2759 <!-- Code embed Component--> 2760</div> 2761 2762<div class="illustration-container__content" id="illustration-container-ae99000cdc" data-cmp-data-layer="{"illustration-container-ae99000cdc":{"@type":"/apps/global/components/globalcomponents/illustration-container/v1/illustration-container","repo:modifyDate":"2026-09-04T01:31:39Z","dc:title":"<h4><span class=\"cmp-weight-styles bold\">Key durations<sup>1</sup></span></h4>\r\n","dc:description":"<ul><li>As part of stabilization, tissue should be fixed in 10% neutral phosphate-buffered formalin (pH 7.0) for at least 6 hours and no longer than 24 to 36 hours</li><li>If the tissue has high fat content, fixation may require up to 48 hours</li></ul>\r\n"}}"> 2763 2764 2765 2766
2767 <!--jobcode--> 2768 2769 <!--kicker--> 2770 2771 2772 <div class="illustration-container__content--title " aria-label="<h4><span class="cmp-weight-styles bold">Key durations<sup>1</sup></span></h4> 2773"><span><h4><span class="cmp-weight-styles bold">Key durations<sup>1</sup></span></h4> 2774</span></div> 2775 2776 2777 <!-- Time & Date from comp dialog--> 2778 2779 <!-- Time & Date from page Properties--> 2780 2781 2782 <div class="illustration-container__content--description "> 2783 <p><ul><li>As part of stabilization, tissue should be fixed in 10% neutral phosphate-buffered formalin (pH 7.0) for at least 6 hours and no longer than 24 to 36 hours</li><li>If the tissue has high fat content, fixation may require up to 48 hours</li></ul> 2784</p> 2785 </div> 2786 2787 2788 2789 2790 <!-- Card Reference Component--> 2791 2792</div></div> 2793 2794 2795 2796 2797 </div> 2798</div> 2799 2800 2801</div> 2802</div> 2803 2804 </div> 2805</div> 2806<div class="separator bottom-space-xl top-space-xl cmp-remove-margin-seperator cmp-separator--primary__mid"><div id="separator-a96d50e97a" class="cmp-separator"> 2807 <hr class="cmp-separator__horizontal-rule"/> 2808</div> 2809</div> 2810<div class="text bottom-space-xs bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--primary-page-subtitle"> 2811<div data-cmp-data-layer="{"text-931de74943":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-15T16:56:06Z","xdm:text":"<h2>Specimen preparation<sup>1,2</sup></h2>\n"}}" id="text-931de74943" class="cmp-text"> 2812 <h2>Specimen preparation<sup>1,2</sup></h2> 2813 2814</div> 2815 2816 2817 2818</div> 2819<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2820<div data-cmp-data-layer="{"text-e8537dad5d":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-09-01T21:29:47Z","xdm:text":"<ul>\n<li>Routinely processed, formalin-fixed, paraffin-embedded (FFPE) tissues are suitable for use with IHC testing<ul>\n<li style=\"list-style-type: disc;\">Low-melt paraffin should be melted at &lt;60 °C</li>\n<li style=\"list-style-type: disc;\">Specimen should contain sufficient tumor tissue for analysis</li>\n</ul>\n</li>\n<li>Specimens that are fine-needle aspirate (FNA), cytology specimens, or metastatic bone lesion do not qualify for CLDN18 staining</li>\n<li>Tissue sections should be cut at ~4 μm thick with a range from 3 μm to 5 μm*</li>\n<li>It is recommended that slides are stained immediately, as antigenicity of cut tissue sections may diminish over time</li>\n</ul>\n"}}" id="text-e8537dad5d" class="cmp-text"> 2821 <ul><li>Routinely processed, formalin-fixed, paraffin-embedded (FFPE) tissues are suitable for use with IHC testing<ul><li style=" list-style-type: disc; 2822">Low-melt paraffin should be melted at <60 °C</li><li style=" list-style-type: disc; 2823">Specimen should contain sufficient tumor tissue for analysis</li></ul> 2824</li><li>Specimens that are fine-needle aspirate (FNA), cytology specimens, or metastatic bone lesion do not qualify for CLDN18 staining</li><li>Tissue sections should be cut at ~4 μm thick with a range from 3 μm to 5 μm*</li><li>It is recommended that slides are stained immediately, as antigenicity of cut tissue sections may diminish over time</li></ul> 2825 2826</div> 2827 2828 2829 2830</div> 2831<div class="text text-styling step--1 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2832<div data-cmp-data-layer="{"text-dc8df46a90":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-16T19:27:27Z","xdm:text":"<p>*CLDN18-specific.</p>\r\n"}}" id="text-dc8df46a90" class="cmp-text"> 2833 <p>*CLDN18-specific.</p> 2834 2835</div> 2836 2837 2838 2839</div> 2840<div class="separator bottom-space-xl top-space-xl cmp-remove-margin-seperator cmp-separator--primary__mid"><div id="separator-e03d289548" class="cmp-separator"> 2841 <hr class="cmp-separator__horizontal-rule"/> 2842</div> 2843</div>
2844<div class="text bottom-space-s bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--primary-page-subtitle"> 2845<div data-cmp-data-layer="{"text-bd570617b0":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T17:37:46Z","xdm:text":"<h2>Storage conditions<sup>2,6</sup></h2>"}}" id="text-bd570617b0" class="cmp-text"> 2846 <h2>Storage conditions<sup>2,6</sup></h2> 2847</div> 2848 2849 2850 2851</div> 2852<div class="text bottom-space-xs text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2853<div data-cmp-data-layer="{"text-acbb899e1c":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-06T16:39:20Z","xdm:text":"<p>Cut slides/FFPE tissue should be:</p>\r\n"}}" id="text-acbb899e1c" class="cmp-text"> 2854 <p>Cut slides/FFPE tissue should be:</p> 2855 2856</div> 2857 2858 2859 2860</div> 2861<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2862<div data-cmp-data-layer="{"text-94b0c8d20f":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-06T16:43:56Z","xdm:text":"<ul>\r\n<li>Desiccated</li>\r\n<li>Stored at room temperature</li>\r\n<li>Stored out of direct sunlight</li>\r\n<li>Kept away from an open flame or direct heat source</li>\r\n</ul>\r\n"}}" id="text-94b0c8d20f" class="cmp-text"> 2863 <ul><li>Desiccated</li><li>Stored at room temperature</li><li>Stored out of direct sunlight</li><li>Kept away from an open flame or direct heat source</li></ul> 2864 2865</div> 2866 2867 2868 2869</div> 2870<div class="text bottom-space-xs text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--primary-page-subtitle"> 2871<div data-cmp-data-layer="{"text-7457ece7c0":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-06T16:45:34Z","xdm:text":"<p>Environmental factors affect antigen stability, and antigenicity decreases over time; therefore:</p>"}}" id="text-7457ece7c0" class="cmp-text"> 2872 <p>Environmental factors affect antigen stability, and antigenicity decreases over time; therefore:</p> 2873</div> 2874 2875 2876 2877</div> 2878<div class="text text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2879<div data-cmp-data-layer="{"text-434cce1e04":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-16T19:34:13Z","xdm:text":"<ul>\n<li>The VENTANA method sheet (package insert) recommends that laboratories validate cut slide stability within their own environment beyond 45 days</li>\n<li>Discovery Life Sciences recommends using slides within one calendar month from the date of sectioning</li>\n</ul>"}}" id="text-434cce1e04" class="cmp-text"> 2880 <ul><li>The VENTANA method sheet (package insert) recommends that laboratories validate cut slide stability within their own environment beyond 45 days</li><li>Discovery Life Sciences recommends using slides within one calendar month from the date of sectioning</li></ul> 2881</div> 2882 2883 2884 2885</div> 2886<div class="separator bottom-space-xl top-space-xl cmp-remove-margin-seperator cmp-separator--primary__mid"><div id="separator-b98cf07df8" class="cmp-separator"> 2887 <hr class="cmp-separator__horizontal-rule"/> 2888</div> 2889</div> 2890<div class="text bottom-space-2xs bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--primary-page-subtitle"> 2891<div data-cmp-data-layer="{"text-c215ad669c":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-20T16:00:03Z","xdm:text":"<h3>Suboptimal tissue fixation<sup>1</sup></h3>\r\n"}}" id="text-c215ad669c" class="cmp-text"> 2892 <h3>Suboptimal tissue fixation<sup>1</sup></h3> 2893 2894</div> 2895 2896 2897 2898</div>
2899<div class="text bottom-space-m text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2900<div data-cmp-data-layer="{"text-84fa1c9378":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-13T14:18:39Z","xdm:text":"<p>It is important to optimize preanalytical variables to minimize staining artifacts.</p>\r\n"}}" id="text-84fa1c9378" class="cmp-text"> 2901 <p>It is important to optimize preanalytical variables to minimize staining artifacts.</p> 2902 2903</div> 2904 2905 2906 2907</div> 2908<div class="image bottom-space-s"> 2909 2910 2911<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=%7B.width%7D&ts=1790348524631&dpr=off" data-asset-id="70dac984-84fb-4fcd-8551-9fc2f425b20d" id="image-b258000ae1" data-cmp-data-layer="{"image-b258000ae1":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:32:04Z","image":{"repo:id":"70dac984-84fb-4fcd-8551-9fc2f425b20d","repo:modifyDate":"2026-09-25T15:02:04Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 2912 2913 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&ts=1790348524631&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=400&ts=1790348524631&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=600&ts=1790348524631&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=800&ts=1790348524631&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=1000&ts=1790348524631&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=1200&ts=1790348524631&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=1400&ts=1790348524631&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=1800&ts=1790348524631&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-clyptophasmic-d?qlt=82&wid=2000&ts=1790348524631&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="5104" height="2868" alt="Cytoplasmic blushing due to suboptimal fixation"/> 2914 2915 2916 2917</div> 2918 2919 2920 2921</div> 2922<div class="text bottom-space-m bold-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 2923<div data-cmp-data-layer="{"text-da28576f09":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-06T17:56:13Z","xdm:text":"<p style=\"text-align: center;\">Suboptimal tissue fixation can cause cytoplasmic blushing and interfere with accurate membranous scoring.</p>\r\n"}}" id="text-da28576f09" class="cmp-text"> 2924 <p style=" text-align: center; 2925">Suboptimal tissue fixation can cause cytoplasmic blushing and interfere with accurate membranous scoring.</p> 2926 2927</div> 2928 2929 2930 2931</div> 2932 2933 2934 </div> 2935 2936 2937</section></div> 2938 2939 2940 </div> 2941 2942</div> 2943<div class="container responsivegrid"> 2944 2945 2946 2947 2948 2949 2950 2951 2952 <div id="container-9b5239d917" class="cmp-container" style="background:#35373c;"> 2953 2954 <div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l top-padding-l"> 2955<section style=";"> 2956 2957 2958 2959 2960 2961 2962 2963 2964 2965 <div id="container-1be9dc9fd4" class="cmp-container"> 2966
2967 <div class="text bottom-space-m bold-styling step-4 cmp-weight-styles bold cmp-element__colorcode--white-500"> 2968<div data-cmp-data-layer="{"ihc-testing":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-24T21:19:53Z","xdm:text":"<h2>Testing</h2>\r\n"}}" id="ihc-testing" class="cmp-text"> 2969 <h2>Testing</h2> 2970 2971</div> 2972 2973 2974 2975</div> 2976<div class="text bottom-space-xs bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--white-500"> 2977<div data-cmp-data-layer="{"text-ac0f53538d":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-07T19:20:30Z","xdm:text":"<h3>Antibody options for evaluating CLDN18.2 expression via IHC<sup>2,7,8</sup></h3>\n"}}" id="text-ac0f53538d" class="cmp-text"> 2978 <h3>Antibody options for evaluating CLDN18.2 expression via IHC<sup>2,7,8</sup></h3> 2979 2980</div> 2981 2982 2983 2984</div> 2985<div class="text bottom-space-l text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 2986<div data-cmp-data-layer="{"text-9cf3f86895":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-06T18:37:20Z","xdm:text":"<p>A number of assays and antibodies are available to assess CLDN18.2 expression. The list below is not exhaustive. An appropriate, validated IHC antibody/assay with high performance should be used when guiding clinical decision-making.</p>\r\n"}}" id="text-9cf3f86895" class="cmp-text"> 2987 <p>A number of assays and antibodies are available to assess CLDN18.2 expression. The list below is not exhaustive. An appropriate, validated IHC antibody/assay with high performance should be used when guiding clinical decision-making.</p> 2988 2989</div> 2990 2991 2992 2993</div> 2994<div class="image rounded-corner cmp-mobile"> 2995 2996 2997<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=%7B.width%7D&ts=1790348520289&$transperant$&wid=400&dpr=off" data-asset-id="be39315a-1e6e-4abb-99e1-037eac74ac9c" id="image-92d7eaea83" data-cmp-data-layer="{"image-92d7eaea83":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:32:35Z","image":{"repo:id":"be39315a-1e6e-4abb-99e1-037eac74ac9c","repo:modifyDate":"2026-09-25T15:02:00Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-table-testing-m.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 2998 2999 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&ts=1790348520289&$transperant$&wid=400&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=400&ts=1790348520289&$transperant$&wid=400&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=600&ts=1790348520289&$transperant$&wid=400&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=800&ts=1790348520289&$transperant$&wid=400&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=1000&ts=1790348520289&$transperant$&wid=400&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=1200&ts=1790348520289&$transperant$&wid=400&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=1400&ts=1790348520289&$transperant$&wid=400&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=1800&ts=1790348520289&$transperant$&wid=400&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-m?qlt=82&wid=2000&ts=1790348520289&$transperant$&wid=400&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="1324" height="883" alt/> 3000 3001 3002 3003</div> 3004 3005 3006 3007</div> 3008<div class="image rounded-corner cmp-desktop cmp-border-radius--s"> 3009 3010 3011<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=%7B.width%7D&ts=1790348526250&$transperant$&dpr=off" data-asset-id="366e8ff8-c6dc-4441-8ff0-b749bac72e6f" id="image-603bc95b8a" data-cmp-data-layer="{"image-603bc95b8a":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:32:28Z","image":{"repo:id":"366e8ff8-c6dc-4441-8ff0-b749bac72e6f","repo:modifyDate":"2026-09-25T15:02:06Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-table-testing-d.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3012 3013 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&ts=1790348526250&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=400&ts=1790348526250&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=600&ts=1790348526250&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=800&ts=1790348526250&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=1000&ts=1790348526250&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=1200&ts=1790348526250&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=1400&ts=1790348526250&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=1800&ts=1790348526250&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-table-testing-d?qlt=82&wid=2000&ts=1790348526250&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="5104" height="3403" alt/> 3014 3015 3016 3017</div> 3018 3019 3020 3021</div> 3022 3023 3024 </div> 3025 3026 3027</section></div> 3028 3029 3030 </div> 3031 3032</div> 3033<div class="container responsivegrid"> 3034 3035 3036 3037 3038 3039 3040 3041 3042 <div id="container-e72b65d720" class="cmp-container" style="background:#5D5F63;"> 3043 3044 <div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l top-padding-l"> 3045<section style=";"> 3046 3047 3048 3049 3050 3051 3052 3053 3054 3055 <div id="container-b7b7e16a6a" class="cmp-container"> 3056
3057 <div class="text bottom-space-m bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3058<div data-cmp-data-layer="{"text-b73bf99309":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-13T14:43:14Z","xdm:text":"<h2>Select appropriate controls</h2>\r\n"}}" id="text-b73bf99309" class="cmp-text"> 3059 <h2>Select appropriate controls</h2> 3060 3061</div> 3062 3063 3064 3065</div> 3066<div class="text bottom-space-l text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3067<div data-cmp-data-layer="{"text-d90fa5d2a8":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T17:51:25Z","xdm:text":"<p>Appropriate controls are essential for the detection of CLDN18.2 in G/GEJ tumor samples. Here are some key points on their selection and use.<sup>2,9</sup></p>"}}" id="text-d90fa5d2a8" class="cmp-text"> 3068 <p>Appropriate controls are essential for the detection of CLDN18.2 in G/GEJ tumor samples. Here are some key points on their selection and use.<sup>2,9</sup></p> 3069</div> 3070 3071 3072 3073</div> 3074<div class="text bottom-space-s bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3075<div data-cmp-data-layer="{"text-07b1fffd6d":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-13T14:48:11Z","xdm:text":"<h3>Validation controls</h3>\r\n"}}" id="text-07b1fffd6d" class="cmp-text"> 3076 <h3>Validation controls</h3> 3077 3078</div> 3079 3080 3081 3082</div> 3083<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3084<div data-cmp-data-layer="{"text-62f963d82e":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T17:51:37Z","xdm:text":"<p>Guidelines recommend that laboratories validate and/or verify immunohistochemical tests before placing them into clinical service. The
3084se tests should include positive, negative, and borderline tissue, reflecting the intended use of the assay.<sup>10</sup></p>"}}" id="text-62f963d82e" class="cmp-text"> 3085 <p>Guidelines recommend that laboratories validate and/or verify immunohistochemical tests before placing them into clinical service. These tests should include positive, negative, and borderline tissue, reflecting the intended use of the assay.<sup>10</sup></p> 3086</div> 3087 3088 3089 3090</div> 3091<div class="text bottom-space-m text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3092<div data-cmp-data-layer="{"text-197d946559":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-07-28T17:37:49Z","xdm:text":"<p>Tissue controls are commercially available through various providers.</p>\r\n"}}" id="text-197d946559" class="cmp-text"> 3093 <p>Tissue controls are commercially available through various providers.</p> 3094 3095</div> 3096 3097 3098 3099</div> 3100<div class="global-link cmp-global-link-primary step-0"> 3101 3102 3103 3104 3105 <ul> 3106 <li> 3107 3108 3109 3110 3111 3112 3113 3114 3115 <a href="javascript:void(0);" class="actionModalOpen" data-modal-id="redirect-1" data-modal-link="https://dls.com/cldn182/" data-cmp-data-layer="{"global-link-9863e80404-headerlink-item0null":{ 3116 "xdm:linkTarget" : "_blank", 3117 "xdm:linkType" : "external", 3118 "xdm:linkURL" : "https://dls.com/cldn182/", 3119 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 3120 "dc:title" : "Learn More" 3121}}" target="_blank" data-cmp-clickable> 3122 3123 <span>Learn More</span> 3124 3125 3126 </a> 3127 3128 3129 3130 3131 3132 3133 </li> 3134 </ul> 3135</div> 3136<div class="separator bottom-space-xl top-space-xl cmp-remove-margin-seperator cmp-separator--primary__mid"><div id="separator-43d53a4381" class="cmp-separator"> 3137 <hr class="cmp-separator__horizontal-rule"/> 3138</div> 3139</div> 3140<div class="text bottom-space-s bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3141<div data-cmp-data-layer="{"text-137a2cccbd":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-16T19:45:23Z","xdm:text":"<h3>Run controls<sup>2</sup></h3>\r\n"}}" id="text-137a2cccbd" class="cmp-text"> 3142 <h3>Run controls<sup>2</sup></h3> 3143 3144</div> 3145 3146 3147 3148</div> 3149<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3150<div data-cmp-data-layer="{"text-e3bed2ad2c":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-19T21:17:16Z","xdm:text":"<ul>\n<li>It is recommended to use optimal run controls, including positives and negatives</li>\n<li>Gastric intestinal metaplasia tissue is an example of an appropriate positive and negative control as it demonstrates<ul>\n<li style=\"list-style-type: disc;\">Strong membranous staining in normal gastric epithelial cells</li>\n<li style=\"list-style-type: disc;\">Weak-to-moderate membranous staining of epithelial cells in areas of metaplasia</li>\n<li style=\"list-style-type: disc;\">Absence of staining in lamina propria, lymphocytes, smooth muscle, blood vessels, and peripheral nerve</li>\n</ul>\n</li>\n<li>If the positive controls fail to demonstrate staining, results of the test specimen should be considered invali
3150d</li>\n<li>Known positive tissue controls should be utilized only for monitoring performance of reagents and instruments, not as an aid in determining the specific diagnosis of test samples</li>\n</ul>\n"}}" id="text-e3bed2ad2c" class="cmp-text"> 3151 <ul><li>It is recommended to use optimal run controls, including positives and negatives</li><li>Gastric intestinal metaplasia tissue is an example of an appropriate positive and negative control as it demonstrates<ul><li style=" list-style-type: disc; 3152">Strong membranous staining in normal gastric epithelial cells</li><li style=" list-style-type: disc; 3153">Weak-to-moderate membranous staining of epithelial cells in areas of metaplasia</li><li style=" list-style-type: disc; 3154">Absence of staining in lamina propria, lymphocytes, smooth muscle, blood vessels, and peripheral nerve</li></ul> 3155</li><li>If the positive controls fail to demonstrate staining, results of the test specimen should be considered invalid</li><li>Known positive tissue controls should be utilized only for monitoring performance of reagents and instruments, not as an aid in determining the specific diagnosis of test samples</li></ul> 3156 3157</div> 3158 3159 3160 3161</div> 3162 3163 3164 </div> 3165 3166 3167</section></div> 3168 3169 3170 </div> 3171 3172</div> 3173<div class="container responsivegrid"> 3174 3175 3176 3177 3178 3179 3180 3181 3182 <div id="container-d781ef11de" class="cmp-container" style="background:#35373C;"> 3183 3184 <div class="section-container container responsivegrid cmp-full-width-section top-padding-l bottom-padding-m"> 3185<section style=";"> 3186 3187 3188 3189 3190 3191 3192 3193 3194 3195 <div id="container-61ed121959" class="cmp-container"> 3196 3197 <div class="text bottom-space-m bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3198<div data-cmp-data-layer="{"text-f93dbdc018":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T17:52:12Z","xdm:text":"<h2>Considerations for laboratory-developed tests (LDTs)<sup>11</sup></h2>"}}" id="text-f93dbdc018" class="cmp-text"> 3199 <h2>Considerations for laboratory-developed tests (LDTs)<sup>11</sup></h2> 3200</div> 3201 3202 3203 3204</div> 3205<div class="text bottom-space-l text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3206<div data-cmp-data-layer="{"text-4680c62e49":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-29T18:54:12Z","xdm:text":"<p>Companion diagnostic (CDx) assays are clinically validated and approved for use with specific therapies and indications;<br />\r\nhowever, clinical laboratories may opt to use LDTs instead of a CDx assay due to limited resources or lack of access.</p>\r\n"}}" id="text-4680c62e49" class="cmp-text"> 3207 <p>Companion diagnostic (CDx) assays are clinically validated and approved for use with specific therapies and indications;<br /> 3208however, clinical laboratories may opt to use LDTs instead of a CDx assay due to limited resources or lack of access.</p> 3209 3210</div> 3211 3212 3213 3214</div> 3215<div class="text bottom-space-s bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3216<div data-cmp-data-layer="{"text-f208884adc":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-26T21:11:53Z","xdm:text":"<h3>CAP Guidelines for the use of LDTs include the following:</h3>\r\n"}}" id="text-f208884adc" class="cmp-text"> 3217 <h3>CAP Guidelines for the use of LDTs include the following:</h3> 3218 3219</div> 3220 3221 3222 3223</div> 3224<div class="text bottom-space-l text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3225<div data-cmp-data-layer="{"text-de09e8af7b":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-09-11T15:27:06Z","xdm:text":"<ul>\n<li>Laboratories must analytically validate all LDTs before reporting results on patient tissues</li>\n<li>For initial analytic validation or verification of every assay used clinically, laboratories should achieve at least 90% overall concordanceâ¨between the new assay and the comparator assay or expected results</li>\n<li>For initial analytic validation of all predictive LDTs, laboratories should test a minimum of 20 positive and 20 negative tissues</li>\n<li>Laboratories should use validation tissues that have been processed using the same fixative and processing methods as cases that will be tested clinically, when possible</li>\n</ul>\n"}}" id="text-de09e8af7b" class="cmp-text"> 3226 <ul><li>Laboratories must analytically validate all LDTs before reporting results on patient tissues</li><li>For initial analytic validation or verification of every assay used clinically, laboratories should achieve at least 90% overall concordanceâ¨between the new assay and the comparator assay or expected results</li><li>For initial analytic validation of all predictive LDTs, laboratories should test a minimum of 20 positive and 20 negative tissues</li><li>Laboratories should use validation tissues that have been processed using the same fixative and processing methods as cases that will be tested clinically, when possible</li></ul> 3227 3228</div> 3229 3230 3231 3232</div> 3233<div class="cardset"> 3234 <div class="cmp-cardset single-card" data-cmp-data-layer="{"cardset-a4cdd9c41f":{"dc:description":"","repo:modifyDate":"2026-03-04T17:19:09Z","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/prepare-and-test-samples","@type":"global/components/globalcomponents/cardset/v1/cardset","dc:title":""}}"> 3235 <div class="card teaser card-secondary-dark cmp-teaser-content--dark"> 3236 3237 3238 3239 3240 3241 3242 3243 3244 3245<input type="hidden" name="resourcePath" id="resourcePath" value="/content/claudin/hcp/north-america/us/en/prepare-and-test-samples"/> 3246<input type="hidden" name="type" id="type"/> 3247<input type="hidden" name="subtype" id="subtype"/> 3248<input type="hidden" name="channel" id="channel"/> 3249<input type="hidden" name="seatavailability" id="seatavailability"/> 3250<input type="hidden" name="seperator" id="eventDateSep"/> 3251<input type="hidden" name="jobcodeDetail" id="jobcodeDetail"/> 3252<!-- Card starts here --> 3253 3254<div class="cmp-teaser" id="card-571cf5c11c" data-cmp-data-layer="{"card-571cf5c11c":{"@type":"/apps/global/components/globalcomponents/card/v1/card","repo:modifyDate":"2026-06-04T17:52:56Z"}}" data-video-card="false" data-video-has-transcript="false" data-video-plain-transcript="false" data-cmp-typechecked="false" data-cmp-subtypechecked="false" data-cmp-channelchecked="false" data-cmp-seatavailabilitychecked="false" data-cmp-Datechecked="false" data-cmp-Jobcodechecked="false"> 3255 <!-- image text --> 3256 3257 3258 3259 3260 3261 3262 <!-- Load when carousel link is not enabled --> 3263 <div class="cmp-teaser__container no-image no-referencelist"> 3264 3265 <div class="cmp-teaser__content__wrapper"> 3266 <!-- Content--> 3267 <div class="cmp-teaser__content"> 3268 <!--tags--> 3269 3270 3271 3272 3273 <!-- Search Tags for Card --> 3274 3275 3276 <!--kicker--> 3277 3278 3279 3280 3281 <!--title--> 3282 <div class="cmp-card__content__wrapper"> 3283 3284 3285 <!-- Time & Date from comp dialog--> 3286 3287 <!-- Time & Date from page Properties--> 3288 3289 <!-- Start & End Date from Response--> 3290 3291 <!--description--> 3292 3293 </div> 3294 3295 <div class="text bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3296<div data-cmp-data-layer="{"text-366aed396a":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-07-28T18:25:21Z","xdm:text":"<h3><b>
3296CAP Guidelines provide direction on IHC assay validation to help ensure accuracy, reproducibility, and consistency of results<sup>11</sup></b></h3>\n"}}" id="text-366aed396a" class="cmp-text"> 3297 <h3><b>CAP Guidelines provide direction on IHC assay validation to help ensure accuracy, reproducibility, and consistency of results<sup>11</sup></b></h3> 3298 3299</div> 3300 3301 3302 3303</div> 3304 3305 3306 3307 3308 <!-- Container --> 3309 3310 </div> 3311 <!-- Global Link Component--> 3312 3313 </div> 3314 </div> 3315 <!-- Card Reference Component--> 3316 3317 3318</div></div> 3319 3320 3321 3322 </div> 3323</div> 3324 3325 3326 </div> 3327 3328 3329</section></div> 3330 3331 3332 </div> 3333 3334</div> 3335<div class="container responsivegrid"> 3336 3337 3338 3339 3340 3341 3342 3343 3344 <div id="container-d4f4d5bd14" class="cmp-container" style="background:#5D5F63;"> 3345 3346 <div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l top-padding-l"> 3347<section style=";"> 3348 3349 3350 3351 3352 3353 3354 3355 3356 3357 <div id="container-69d5372e6b" class="cmp-container"> 3358 3359 <div class="text bottom-space-m bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3360<div data-cmp-data-layer="{"text-bc0407ae07":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T17:53:40Z","xdm:text":"<h2>CLDN18.2 expression demonstrates intratumoral heterogeneity</h2>\n"}}" id="text-bc0407ae07" class="cmp-text"> 3361 <h2>CLDN18.2 expression demonstrates intratumoral heterogeneity</h2> 3362 3363</div> 3364 3365 3366 3367</div> 3368<div class="text bottom-space-m text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3369<div data-cmp-data-layer="{"text-64fecdf693":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-25T17:26:05Z","xdm:text":"<p>As with other biomarkers (such as HER2), CLDN18.2 expression in G/GEJ cancer exhibits intratumoral heterogeneity, which should be taken into account when sampling tumor tissue.<sup>12,13</sup></p>"}}" id="text-64fecdf693" class="cmp-text"> 3370 <p>As with other biomarkers (such as HER2), CLDN18.2 expression in G/GEJ cancer exhibits intratumoral heterogeneity, which should be taken into account when sampling tumor tissue.<sup>12,13</sup></p> 3371</div> 3372 3373 3374 3375</div> 3376<div class="text bottom-space-m text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3377<div data-cmp-data-layer="{"text-3997800a68":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-07-28T16:52:49Z","xdm:text":"<p>In a study showing high concordance between primary and metastatic tumor samples, <span style=\"color: rgb(85,236,141);\">intratumoral heterogeneity in CLDN18.2 expression was observed in<sup>12*</sup>:</span></p>\n"}}" id="text-3997800a68" class="cmp-text"> 3378 <p>In a study showing high concordance between primary and metastatic tumor samples, <sp
3378an style=" color: rgb(85,236,141); 3379">intratumoral heterogeneity in CLDN18.2 expression was observed in<sup>12*</sup>:</span></p> 3380 3381</div> 3382 3383 3384 3385</div> 3386<div class="image cmp-desktop"> 3387 3388 3389<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=%7B.width%7D&ts=1790779259033&$transperant$&dpr=off" data-asset-id="da8948db-0e5f-4545-9b82-3ab922a8a797" id="image-7378b76cb3" data-cmp-data-layer="{"image-7378b76cb3":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-30T14:40:59Z","image":{"repo:id":"da8948db-0e5f-4545-9b82-3ab922a8a797","repo:modifyDate":"2026-09-25T15:02:03Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-percentages-d.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3390 3391 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&ts=1790779259033&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=400&ts=1790779259033&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=600&ts=1790779259033&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=800&ts=1790779259033&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=1000&ts=1790779259033&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=1200&ts=1790779259033&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=1400&ts=1790779259033&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=1800&ts=1790779259033&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-d?qlt=82&wid=2000&ts=1790779259033&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="5104" height="892" alt/> 3392 3393 3394 3395</div> 3396 3397 3398 3399</div> 3400<div class="image bottom-space-s cmp-mobile"> 3401 3402 3403<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=%7B.width%7D&ts=1790779326313&$transperant$&dpr=off" data-asset-id="a108baa2-9f07-487b-9cb2-15892a319404" id="image-3c3ef5adec" data-cmp-data-layer="{"image-3c3ef5adec":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-30T14:42:06Z","image":{"repo:id":"a108baa2-9f07-487b-9cb2-15892a319404","repo:modifyDate":"2026-09-25T15:02:05Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-percentages-m.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3404 3405 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&ts=1790779326313&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=400&ts=1790779326313&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=600&ts=1790779326313&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=800&ts=1790779326313&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=1000&ts=1790779326313&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=1200&ts=1790779326313&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=1400&ts=1790779326313&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=1800&ts=1790779326313&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-percentages-m?qlt=82&wid=2000&ts=1790779326313&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="1324" height="1324" alt/> 3406 3407 3408 3409</div> 3410 3411 3412 3413</div>
3414<div class="text bottom-space-l text-styling step--1 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3415<div data-cmp-data-layer="{"text-d6820133c8":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-07-24T16:46:20Z","xdm:text":"<p>*Data are from a single-institution study that assessed 523 archival cases of surgically treated gastric (n=408) and gastroesophageal (n=115) cancers. Intratumoral heterogeneity of CLDN18.2 was determined by assessing different samples from the same tumor for concomitant high and low CLDN18 expression.<sup>12</sup></p>\r\n"}}" id="text-d6820133c8" class="cmp-text"> 3416 <p>*Data are from a single-institution study that assessed 523 archival cases of surgically treated gastric (n=408) and gastroesophageal (n=115) cancers. Intratumoral heterogeneity of CLDN18.2 was determined by assessing different samples from the same tumor for concomitant high and low CLDN18 expression.<sup>12</sup></p> 3417 3418</div> 3419 3420 3421 3422</div> 3423<div class="text bottom-space-m bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3424<div data-cmp-data-layer="{"text-50cacb83e7":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T18:04:36Z","xdm:text":"<h2>Navigating intratumoral heterogeneity<sup>14</sup></h2>"}}" id="text-50cacb83e7" class="cmp-text"> 3425 <h2>Navigating intratumoral heterogeneity<sup>14</sup></h2> 3426</div> 3427 3428 3429 3430</div> 3431<div class="text bottom-space-m text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3432<div data-cmp-data-layer="{"text-a8094661e3":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T18:10:49Z","xdm:text":"<p>A single-institution study in Italian patients with G/GEJ adenocarcinoma evaluated the sensitivity and specificity of CLDN18 testing according to the number of virtual biopsies scored on 93 surgically treated cases (77 GC and 16 GEJ), evaluated by two blinded pathologists.</p>\r\n"}}" id="text-a8094661e3" class="cmp-text"> 3433 <p>A single-institution study in Italian patients with G/GEJ adenocarcinoma evaluated the sensitivity and specificity of CLDN18 testing according to the number of virtual biopsies scored on 93 surgically treated cases (77 GC and 16 GEJ), evaluated by two blinded pathologists.</p> 3434 3435</div> 3436 3437 3438 3439</div> 3440<div class="text bottom-space-3xs text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3441<div data-cmp-data-layer="{"text-1137c4e116":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-09T17:02:45Z","xdm:text":"<p>Using the CLDN18.2-positive cutoff of â¥75%:</p>\r\n"}}" id="text-1137c4e116" class="cmp-text"> 3442 <p>Using the CLDN18.2-positive cutoff of â¥75%:</p> 3443 3444</div> 3445 3446 3447 3448</div> 3449<div class="text bottom-space-m text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3450<div data-cmp-data-layer="{"text-4fb7df0fab":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-05T12:15:31Z","xdm:text":"<ul>\r\n<li>Sensitivity increased steadily upon evaluating additional biopsies<ul>\r\n<li style=\"list-style-type: disc;\">From <span style=\"color: rgb(85,236,141);\">92.9%</span> with 2 biopsies to <span style=\"color: rgb(85,236,141);\">100%</span> with 9 biopsies</li>\r\n</ul>\r\n</li>\r\n<li>After 6 biopsies, the increase was minimal<ul>\r\n<li style=\"list-style-type: disc;\">97.7% with 6 biopsies compared with 98.2% with 7 biopsies: <span style=\"color: rgb(85,236,141);\">0.5% increase</span></li>\r\n<li style=\"list-style-type: disc;\">98.2% with 7 biopsies compared with 98.7% with 8 biopsies: <span style=\"color: rgb(85,236,141);\">0.5% increase</span></li>\r\n<li style=\"list-style-type: disc;\">
345098.7% with 8 biopsies compared with 100% with 9 biopsies: <span style=\"color: rgb(85,236,141);\">1.3% increase</span></li>\r\n</ul>\r\n</li>\r\n<li>Similar results have been demonstrated for HER2 testing in G/GEJ adenocarcinoma</li>\r\n</ul>\r\n"}}" id="text-4fb7df0fab" class="cmp-text"> 3451 <ul><li>Sensitivity increased steadily upon evaluating additional biopsies<ul><li style=" list-style-type: disc; 3452">From <span style=" color: rgb(85,236,141); 3453">92.9%</span> with 2 biopsies to <span style=" color: rgb(85,236,141); 3454">100%</span> with 9 biopsies</li></ul> 3455</li><li>After 6 biopsies, the increase was minimal<ul><li style=" list-style-type: disc; 3456">97.7% with 6 biopsies compared with 98.2% with 7 biopsies: <span style=" color: rgb(85,236,141); 3457">0.5% increase</span></li><li style=" list-style-type: disc; 3458">98.2% with 7 biopsies compared with 98.7% with 8 biopsies: <span style=" color: rgb(85,236,141); 3459">0.5% increase</span></li><li style=" list-style-type: disc; 3460">98.7% with 8 biopsies compared with 100% with 9 biopsies: <span style=" color: rgb(85,236,141); 3461">1.3% increase</span></li></ul> 3462</li><li>Similar results have been demonstrated for HER2 testing in G/GEJ adenocarcinoma</li></ul> 3463 3464</div> 3465 3466 3467 3468</div> 3469<div class="image cmp-mobile"> 3470 3471 3472<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=%7B.width%7D&ts=1790348523936&$transperant$&dpr=off" data-asset-id="b58af63e-d563-4ced-9412-5c4606f91090" id="image-dc2ea96e38" data-cmp-data-layer="{"image-dc2ea96e38":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:33:06Z","image":{"repo:id":"b58af63e-d563-4ced-9412-5c4606f91090","repo:modifyDate":"2026-09-25T15:02:03Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-graphic-m.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3473 3474 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&ts=1790348523936&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=400&ts=1790348523936&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=600&ts=1790348523936&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=800&ts=1790348523936&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=1000&ts=1790348523936&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=1200&ts=1790348523936&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=1400&ts=1790348523936&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=1800&ts=1790348523936&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-m?qlt=82&wid=2000&ts=1790348523936&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="1324" height="662" alt="CLDN18.2-Positive Cutoff of â¥75%"/> 3475 3476 3477 3478</div> 3479 3480 3481 3482</div> 3483<div class="image cmp-desktop"> 3484 3485 3486<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=%7B.width%7D&ts=1790348523419&$transperant$&dpr=off" data-asset-id="f8d5098b-3cda-4d82-b887-205580fcee89" id="image-f4d072b827" data-cmp-data-layer="{"image-f4d072b827":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:32:55Z","image":{"repo:id":"f8d5098b-3cda-4d82-b887-205580fcee89","repo:modifyDate":"2026-09-25T15:02:03Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-graphic-d.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3487 3488 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&ts=1790348523419&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=400&ts=1790348523419&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=600&ts=1790348523419&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=800&ts=1790348523419&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=1000&ts=1790348523419&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=1200&ts=1790348523419&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=1400&ts=1790348523419&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=1800&ts=1790348523419&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphic-d?qlt=82&wid=2000&ts=1790348523419&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="5104" height="2552" alt="CLDN18.2-Positive Cutoff of â¥75%"/> 3489 3490 3491 3492</div> 3493 3494 3495 3496</div> 3497<div class="cardset"> 3498 <div class="cmp-cardset single-card" data-cmp-data-layer="{"cardset-963c6599a2":{"dc:description":"","repo:modifyDate":"2026-03-04T17:19:09Z","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/prepare-and-test-samples","@type":"global/components/globalcomponents/cardset/v1/cardset","dc:title":""}}"> 3499 <div class="card teaser card-secondary-dark cmp-teaser-content--dark"> 3500 3501 3502 3503 3504 3505 3506 3507 3508 3509<input type="hidden" name="resourcePath" id="resourcePath" value="/content/claudin/hcp/north-america/us/en/prepare-and-test-samples"/> 3510<input type="hidden" name="type" id="type"/> 3511<input type="hidden" name="subtype" id="subtype"/> 3512<input type="hidden" name="channel" id="channel"/> 3513<input type="hidden" name="seatavailability" id="seatavailability"/> 3514<input type="hidden" name="seperator" id="eventDateSep"/> 3515<input type="hidden" name="jobcodeDetail" id="jobcodeDetail"/> 3516<!-- Card starts here --> 3517 3518<div class="cmp-teaser" id="card-6fd362700a" data-cmp-data-layer="{"card-6fd362700a":{"@type":"/apps/global/components/globalcomponents/card/v1/card","repo:modifyDate":"2026-06-04T17:52:56Z"}}" data-video-card="false" data-video-has-transcript="false" data-video-plain-transcript="false" data-cmp-typechecked="false" data-cmp-subtypechecked="false" data-cmp-channelchecked="false" data-cmp-seatavailabilitychecked="false" data-cmp-Datechecked="false" data-cmp-Jobcodechecked="false"> 3519 <!-- image text --> 3520 3521 3522 3523 3524 3525 3526 <!-- Load when carousel link is not enabled --> 3527 <div class="cmp-teaser__container no-image no-referencelist"> 3528 3529 <div class="cmp-teaser__content__wrapper"> 3530 <!-- Content--> 3531 <div class="cmp-teaser__content"> 3532 <!--tags--> 3533 3534 3535 3536 3537 <!-- Search Tags for Card --> 3538 3539 3540 <!--kicker--> 3541 3542 3543 3544 3545 <!--title--> 3546 <div class="cmp-card__content__wrapper"> 3547 3548 3549 <!-- Time & Date from comp dialog--> 3550 3551 <!-- Time & Date from page Properties--> 3552 3553 <!-- Start & End Date from Response--> 3554 3555 <!--description--> 3556 3557 </div> 3558 3559 <div class="text bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3560<div data-cmp-data-layer="{"text-1d5aba3b78":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-07T19:21:13Z","xdm:text":"<h3><b>Multiple biopsies (ideally, 6+, if tissue allows) should be obtained to more accurately evaluate CLDN18.2 expression.<sup>14,15</sup></b></h3>\n"}}" id="text-1d5aba3b78" class="cmp-text"> 3561 <h3><b>Multiple biopsies (ideally, 6+, if tissue allows) should be obtained to more accurately evaluate CLDN18.2 expression.<sup>14,15</sup></b></h3> 3562 3563</div> 3564 3565 3566 3567</div> 3568 3569 3570 3571 3572 <!-- Container --> 3573 3574 </div> 3575 <!-- Global Link Component--> 3576 3577 </div> 3578 </div> 3579 <!-- Card Reference Component--> 3580 3581 3582</div></div> 3583 3584 3585 3586 </div> 3587</div> 3588 3589 3590 </div> 3591 3592 3593</section></div> 3594 3595 3596 </div> 3597 3598</div> 3599<div class="container responsivegrid"> 3600 3601 3602 3603 3604 3605 3606 3607 3608 <div id="container-46e1fdee8a" class="cmp-container" style="background:#35373C;"> 3609 3610 <div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l top-padding-l"> 3611<section style=";"> 3612 3613 3614 3615 3616 3617 3618 3619 3620 3621 <div id="container-5df8232ed4" class="cmp-container"> 3622
3623 <div class="text bottom-space-m bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3624<div data-cmp-data-layer="{"proficiency-evaluations":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-24T21:12:08Z","xdm:text":"<h2>Proficiency evaluations have identified variability in antibody and platform performance</h2>\r\n"}}" id="proficiency-evaluations" class="cmp-text"> 3625 <h2>Proficiency evaluations have identified variability in antibody and platform performance</h2> 3626 3627</div> 3628 3629 3630 3631</div> 3632<div class="text bottom-space-s bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3633<div data-cmp-data-layer="{"text-b1a54f6398":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T20:13:07Z","xdm:text":"<h3>Global concordance study<sup>9</sup></h3>"}}" id="text-b1a54f6398" class="cmp-text"> 3634 <h3>Global concordance study<sup>9</sup></h3> 3635</div> 3636 3637 3638 3639</div> 3640<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3641<div data-cmp-data-layer="{"text-9a2403f870":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-05-05T21:14:09Z","xdm:text":"<p>In the global concordance study, which assessed the reproducibility and comparability of three CLDN18 antibodiesâVENTANA (43-14A), LSBio (LS-B16145), and Novus (NBP2-32002)âand IHC staining platforms across a cohort of 27 global laboratories, sensitivity, specificity, accuracy, and precision were analyzed.*<sup>,â </sup></p>"}}" id="text-9a2403f870" class="cmp-text"> 3642 <p>In the global concordance study, which assessed the reproducibility and comparability of three CLDN18 antibodiesâVENTANA (43-14A), LSBio (LS-B16145), and Novus (NBP2-32002)âand IHC staining platforms across a cohort of 27 global laboratories, sensitivity, specificity, accuracy, and precision were analyzed.*<sup>,â </sup></p> 3643</div> 3644 3645 3646 3647</div> 3648<div class="columncontainer responsivegrid"> 3649 <div id="columncontainer-6d73717840" class="cmp-columncontainer 3650 cmp-columncontainer--2col-2_1 cmp-columncontainer--spcol-1 3651 3652 "> 3653 3654 3655 <div class="cmp-columncontainer-item"> 3656 3657 3658<div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> 3659 3660 <div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500 aem-GridColumn aem-GridColumn--default--12"> 3661<div data-cmp-data-layer="{"text-b6d1f38dc6":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-19T22:05:45Z","xdm:text":"<ul>\n<li>Analytical performance of the VENTANA assay was &gt;95% and reproducible across all of the 27 laboratories vs consensus reference results</li>\n<li>Analytical performance was equivalent across the VENTANA (43-14A) IVD assay and the LSBio antibody when stained on the Dako or Leica platform; staining was also reproducible for the LSBio antibody</li>\n<li>Performance was less consistent for the Novus antibody compared to the VENTANA assay</li>\n</ul>\n"}}" id="text-b6d1f38dc6" class="cmp-text"> 3662 <ul><li>Analytical performance of the VENTANA assay was >95% and reproducible across all of the 27 laboratories vs consensus reference results</li><li>Analytical performance was equivalent across the VENTANA (43-14A) IVD assay and the LSBio antibody when stained on the Dako or Leica platform; staining was also reproducible for the LSBio antibody</li><li>Performance was less consistent for the Novus antibody compared to the VENTANA assay</li></ul> 3663 3664</div> 3665 3666 3667 3668</div> 3669 3670 3671</div> 3672</div> 3673 3674 3675 <div class="cmp-columncontainer-item"> 3676 3677 3678<div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> 3679
3680 <div class="image bottom-space-s cmp-desktop aem-GridColumn aem-GridColumn--default--12"> 3681 3682 3683<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=%7B.width%7D&ts=1790720871259&$transperant$&dpr=off" data-asset-id="08c52e5d-b39a-4237-9994-08c1089562c6" id="image-a4bb88016a" data-cmp-data-layer="{"image-a4bb88016a":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-29T22:27:51Z","image":{"repo:id":"08c52e5d-b39a-4237-9994-08c1089562c6","repo:modifyDate":"2026-09-25T15:02:05Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-95100-d.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3684 3685 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&ts=1790720871259&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=400&ts=1790720871259&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=600&ts=1790720871259&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=800&ts=1790720871259&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=1000&ts=1790720871259&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=1200&ts=1790720871259&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=1400&ts=1790720871259&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=1800&ts=1790720871259&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-d?qlt=82&wid=2000&ts=1790720871259&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="2508" height="1468" alt/> 3686 3687 3688 3689</div> 3690 3691 3692 3693</div> 3694<div class="image cmp-mobile aem-GridColumn aem-GridColumn--default--12"> 3695 3696 3697<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=%7B.width%7D&ts=1790720878625&$transperant$&dpr=off" data-asset-id="ba26b74d-c4a2-4471-923f-350fc167f2a6" id="image-a5caa8e553" data-cmp-data-layer="{"image-a5caa8e553":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-29T22:27:58Z","image":{"repo:id":"ba26b74d-c4a2-4471-923f-350fc167f2a6","repo:modifyDate":"2026-09-25T15:02:05Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-95100-m.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3698 3699 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&ts=1790720878625&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=400&ts=1790720878625&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=600&ts=1790720878625&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=800&ts=1790720878625&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=1000&ts=1790720878625&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=1200&ts=1790720878625&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=1400&ts=1790720878625&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=1800&ts=1790720878625&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-95100-m?qlt=82&wid=2000&ts=1790720878625&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="1324" height="744" alt/> 3700 3701 3702 3703</div> 3704 3705 3706 3707</div> 3708 3709 3710</div> 3711</div> 3712 3713 </div> 3714</div>
3715<div class="text bottom-space-s text-styling step--1 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3716<div data-cmp-data-layer="{"text-d4eec4825d":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-28T11:11:16Z","xdm:text":"<p><span class=\"small-sup\">*</span>Antibodies in the study comprised the VENTANA CLDN18 (43-14A) IVD&nbsp;Assay from Roche Tissue Diagnostics, the PathPlus⢠CLDN18 Antibody from LSBio, and the Claudin-18 Antibody from Novus Biologicals. Platforms comprised BenchMark ULTRA, Dako Autostainer, and Leica Bond.</p>\r\n"}}" id="text-d4eec4825d" class="cmp-text"> 3717 <p><span class="small-sup">*</span>Antibodies in the study comprised the VENTANA CLDN18 (43-14A) IVD Assay from Roche Tissue Diagnostics, the PathPlus⢠CLDN18 Antibody from LSBio, and the Claudin-18 Antibody from Novus Biologicals. Platforms comprised BenchMark ULTRA, Dako Autostainer, and Leica Bond.</p> 3718 3719</div> 3720 3721 3722 3723</div> 3724<div class="text bottom-space-xl text-styling step--1 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3725<div data-cmp-data-layer="{"text-8445ad76bc":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-28T16:00:04Z","xdm:text":"<p><sup>â </sup>Consensus reference scores from all antibodies for each sample were determined by central pathology review. CLDN18.2 positivity was defined with a threshold of â¥75% of tumor cells expressing membranous CLDN18 with moderate-to-strong (â¥2+) staining intensity. Accordingly, participating pathologists were required to submit a binary positive/negative call as well as an estimation of the percent of cells stained. Laboratory-submitted IHC scores were compared to the reference consensus score and considered discordant if the positive/negative binary result differed. Statistical analysis was performed for comparison, and an acceptance criteria of 85% (â¥0.85) was applied.</p>"}}" id="text-8445ad76bc" class="cmp-text"> 3726 <p><sup>â </sup>Consensus reference scores from all antibodies for each sample were determined by central pathology review. CLDN18.2 positivity was defined with a threshold of â¥75% of tumor cells expressing membranous CLDN18 with moderate-to-strong (â¥2+) staining intensity. Accordingly, participating pathologists were required to submit a binary positive/negative call as well as an estimation of the percent of cells stained. Laboratory-submitted IHC scores were compared to the reference consensus score and considered discordant if the positive/negative binary result differed. Statistical analysis was performed for comparison, and an acceptance criteria of 85% (â¥0.85) was applied.</p> 3727</div> 3728 3729 3730 3731</div> 3732<div class="separator bottom-space-s top-space-s cmp-remove-margin-seperator cmp-separator--primary__mid"><div id="separator-4156359071" class="cmp-separator"> 3733 <hr class="cmp-separator__horizontal-rule"/> 3734</div> 3735</div> 3736<div class="text bottom-space-m top-space-2xl bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3737<div data-cmp-data-layer="{"text-56d26b24d5":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-13T15:51:51Z","xdm:text":"<h3>NordiQC external quality assessment results from Run C17*</h3>\r\n"}}" id="text-56d26b24d5" class="cmp-text"> 3738 <h3>NordiQC external quality assessment results from Run C17*</h3> 3739 3740</div> 3741 3742 3743 3744</div> 3745<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3746<div data-cmp-data-layer="{"text-d3e7897b40":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-10T15:57:52Z","xdm:text":"<p>The objective of the NordiQC EQA was to evaluate the analytical accuracy of IHC assays for detecting CLDN18.2. 75 laboratories participated in this first assessment with ~87% (65/75) achieving a sufficient mark.<sup>16</sup></p>"}}" id="text-d3e7897b40" class="cmp-text"> 3747 <p>The objective of the NordiQC EQA was to evaluate the analytical accuracy of IHC assays for detecting CLDN18.2. 75 laboratories participated in this first assessment with ~87% (65/75) achieving a sufficient mark.<sup>16</sup></p> 3748</div> 3749 3750 3751 3752</div>
3753<div class="text bottom-space-xs text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3754<div data-cmp-data-layer="{"text-67e133c532":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-10T15:58:38Z","xdm:text":"<ul>\r\n<li>âSufficientâ stains were defined as âoptimalâ +&nbsp; âgoodâ</li>\r\n</ul>\r\n"}}" id="text-67e133c532" class="cmp-text"> 3755 <ul><li>âSufficientâ stains were defined as âoptimalâ + âgoodâ</li></ul> 3756 3757</div> 3758 3759 3760 3761</div> 3762<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3763<div data-cmp-data-layer="{"text-8bbf06a8d9":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-04-05T12:21:31Z","xdm:text":"<ul>\r\n<li>100% of IHC stains submitted using the CE-IVD VENTANA CLDN18 (43-14A) Assay were marked as âsufficient,â of which ~89% (8/9) were âoptimalâ</li>\r\n<li>For the assessment of 6 concentrated antibodies<ul>\r\n<li style=\"list-style-type: disc;\">Only ~46% (6/13) of IHC stains submitted were marked as âsufficientâ</li>\r\n<li style=\"list-style-type: disc;\">The monoclonal antibody clone 43-14A was the most successful compared with other clones, with 80% (4/5) marked as âsufficientâ</li>\r\n<li style=\"list-style-type: disc;\">Insufficient results were mainly caused by too weak or false negative staining reaction in gastric carcinomas expected to have â¥75% positivity</li>\r\n</ul>\r\n</li>\r\n</ul>\r\n"}}" id="text-8bbf06a8d9" class="cmp-text"> 3764 <ul><li>100% of IHC stains submitted using the CE-IVD VENTANA CLDN18 (43-14A) Assay were marked as âsufficient,â of which ~89% (8/9) were âoptimalâ</li><li>For the assessment of 6 concentrated antibodies<ul><li style=" list-style-type: disc; 3765">Only ~46% (6/13) of IHC stains submitted were marked as âsufficientâ</li><li style=" list-style-type: disc; 3766">The monoclonal antibody clone 43-14A was the most successful compared with other clones, with 80% (4/5) marked as âsufficientâ</li><li style=" list-style-type: disc; 3767">Insufficient results were mainly caused by too weak or false negative staining reaction in gastric carcinomas expected to have â¥75% positivity</li></ul> 3768</li></ul> 3769 3770</div> 3771 3772 3773 3774</div> 3775<div class="image cmp-desktop"> 3776 3777 3778<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=%7B.width%7D&ts=1790348525664&$transperant$&dpr=off" data-asset-id="2fa0a005-28c9-4e3f-849c-ea8f1d316973" id="image-cf2b1d1aa6" data-cmp-data-layer="{"image-cf2b1d1aa6":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:33:28Z","image":{"repo:id":"2fa0a005-28c9-4e3f-849c-ea8f1d316973","repo:modifyDate":"2026-09-25T15:02:05Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3779 3780 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&ts=1790348525664&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=400&ts=1790348525664&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=600&ts=1790348525664&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=800&ts=1790348525664&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=1000&ts=1790348525664&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=1200&ts=1790348525664&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=1400&ts=1790348525664&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=1800&ts=1790348525664&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-d?qlt=82&wid=2000&ts=1790348525664&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="5104" height="1880" alt="IHC Stains from VENTANA CLDN18.2(43-14A) Assay and Concentrated Antibodies"/> 3781 3782 3783 3784</div> 3785 3786 3787 3788</div> 3789<div class="image cmp-mobile"> 3790 3791 3792<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=%7B.width%7D&ts=1790348519806&$transperant$&dpr=off" data-asset-id="8395d232-1fa8-4f7a-8f4b-2319b0a7a8ee" id="image-54e1b4a8ec" data-cmp-data-layer="{"image-54e1b4a8ec":{"@type":"core/wcm/components/image/v3/image","repo:modifyDate":"2026-09-04T01:33:43Z","image":{"repo:id":"8395d232-1fa8-4f7a-8f4b-2319b0a7a8ee","repo:modifyDate":"2026-09-25T15:01:59Z","@type":"image/png","repo:path":"/content/dam/claudin/hcp/north-america/us/en/images/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m.png"}}}" data-cmp-hook-image="imageV3" class="cmp-image " itemscope itemtype="http://schema.org/ImageObject"> 3793 3794 <img src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&ts=1790348519806&$transperant$&dpr=off" srcset="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=400&ts=1790348519806&$transperant$&dpr=off 400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=600&ts=1790348519806&$transperant$&dpr=off 600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=800&ts=1790348519806&$transperant$&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=1000&ts=1790348519806&$transperant$&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=1200&ts=1790348519806&$transperant$&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=1400&ts=1790348519806&$transperant$&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=1800&ts=1790348519806&$transperant$&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-graphics-ihc-m?qlt=82&wid=2000&ts=1790348519806&$transperant$&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="1324" height="2316" alt="IHC Stains from VENTANA CLDN18.2(43-14A) Assay and Concentrated Antibodies"/> 3795 3796 3797 3798</div> 3799 3800 3801 3802</div>
3803<div class="text bottom-space-2xs text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3804<div data-cmp-data-layer="{"text-ab8b0b4e1a":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-10T16:14:05Z","xdm:text":"<p>NordiQC is a professional scientific organization that conducts EQAs for immunohistochemistry proficiency.<sup>17</sup></p>"}}" id="text-ab8b0b4e1a" class="cmp-text"> 3805 <p>NordiQC is a professional scientific organization that conducts EQAs for immunohistochemistry proficiency.<sup>17</sup></p> 3806</div> 3807 3808 3809 3810</div> 3811<div class="text text-styling step--1 cmp-weight-styles regular cmp-element__colorcode--white-500"> 3812<div data-cmp-data-layer="{"text-084551dc0c":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-15T17:03:44Z","xdm:text":"<p>*NordiQC EQA sponsored by Astellas.</p>\r\n"}}" id="text-084551dc0c" class="cmp-text"> 3813 <p>*NordiQC EQA sponsored by Astellas.</p> 3814 3815</div> 3816 3817 3818 3819</div> 3820 3821 3822 </div> 3823 3824 3825</section></div> 3826 3827 3828 </div> 3829 3830</div> 3831<div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l top-padding-l"> 3832<section style=";"> 3833 3834 3835 3836 3837 3838 3839 3840 3841 3842 <div id="container-1726e16d04" class="cmp-container"> 3843 3844 <div class="text bottom-space-l bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--page-title"> 3845<div data-cmp-data-layer="{"reflexive-testing":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-24T21:08:57Z","xdm:text":"<h2>The G/GEJ adenocarcinoma landscape continues to evolve, with emerging considerations for testing approaches</h2>\r\n"}}" id="reflexive-testing" class="cmp-text"> 3846 <h2>The G/GEJ adenocarcinoma landscape continues to evolve, with emerging considerations for testing approaches</h2> 3847 3848</div> 3849 3850 3851 3852</div> 3853<div class="cardset bottom-space-l"> 3854 <div class="cmp-cardset single-card" data-cmp-data-layer="{"cardset-c8789a83df":{"dc:description":"","repo:modifyDate":"2026-03-04T17:19:09Z","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/prepare-and-test-samples","@type":"global/components/globalcomponents/cardset/v1/cardset","dc:title":""}}"> 3855 <div class="card teaser card-secondary-dark cmp-teaser-content--dark"> 3856 3857 3858 3859 3860 3861 3862 3863 3864 3865<input type="hidden" name="resourcePath" id="resourcePath" value="/content/claudin/hcp/north-america/us/en/prepare-and-test-samples"/> 3866<input type="hidden" name="type" id="type"/> 3867<input type="hidden" name="subtype" id="subtype"/> 3868<input type="hidden" name="channel" id="channel"/> 3869<input type="hidden" name="seatavailability" id="seatavailability"/> 3870<input type="hidden" name="seperator" id="eventDateSep"/> 3871<input type="hidden" name="jobcodeDetail" id="jobcodeDetail"/> 3872<!-- Card starts here --> 3873 3874<div class="cmp-teaser" id="card-f69952b730" data-cmp-data-layer="{"card-f69952b730":{"@type":"/apps/global/components/globalcomponents/card/v1/card","repo:modifyDate":"2026-06-04T20:28:46Z"}}" data-video-card="false" data-video-has-transcript="false" data-video-plain-transcript="false" data-cmp-typechecked="false" data-cmp-subtypechecked="false" data-cmp-channelchecked="false" data-cmp-seatavailabilitychecked="false" data-cmp-Datechecked="false" data-cmp-Jobcodechecked="false"> 3875 <!-- image text --> 3876 3877 3878 3879 3880 3881 3882 <!-- Load when carousel link is not enabled --> 3883 <div class="cmp-teaser__container no-image no-referencelist"> 3884 3885 <div class="cmp-teaser__content__wrapper"> 3886 <!-- Content--> 3887 <div class="cmp-teaser__content"> 3888 <!--tags--> 3889 3890 3891 3892 3893 <!-- Search Tags for Card --> 3894 3895 3896 <!--kicker--> 3897 3898 3899 3900 3901 <!--title--> 3902 <div class="cmp-card__content__wrapper"> 3903 3904 3905 <!-- Time & Date from comp dialog--> 3906 3907 <!-- Time & Date from page Properties--> 3908 3909 <!-- Start & End Date from Response--> 3910 3911 <!--description--> 3912 3913 </div> 3914 3915 <div class="text bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--white-500"> 3916<div data-cmp-data-layer="{"text-dfd1256b46":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-19T21:49:37Z","xdm:text":"<h2><b>Reflexive testing may improve patient care through timely availability of biomarker results and initiation of optimal systemic therapy<sup>18</sup></b></h2>\n"}}" id="text-dfd1256b46" class="cmp-text"> 3917 <h2><b>Reflexive testing may improve patient care through timely availability of biomarker results and initiation of optimal systemic therapy<sup>18</sup></b></h2> 3918 3919</div> 3920 3921 3922 3923</div> 3924 3925 3926 3927 3928 <!-- Container --> 3929 3930 </div> 3931 <!-- Global Link Component--> 3932 3933 </div> 3934 </div> 3935 <!-- Card Reference Component--> 3936 3937 3938</div></div> 3939 3940 3941 3942 </div> 3943</div>
3944<div class="text bottom-space-s bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--neutral-500"> 3945<div data-cmp-data-layer="{"text-df87732ed2":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T22:21:50Z","xdm:text":"<h3>Rationale for Reflex Testing<sup>18</sup></h3>"}}" id="text-df87732ed2" class="cmp-text"> 3946 <h3>Rationale for Reflex Testing<sup>18</sup></h3> 3947</div> 3948 3949 3950 3951</div> 3952<div class="text bottom-space-xl text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 3953<div data-cmp-data-layer="{"text-7ea09877eb":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T20:30:26Z","xdm:text":"<p>Expert consensus supports reflex biomarker testing in G/GEJ adenocarcinoma to ensure that clinically relevant biomarker results are available at the time of initial oncology consultation, helping to facilitate timely treatment decisionâmaking and improve overall patient care. </p>\n"}}" id="text-7ea09877eb" class="cmp-text"> 3954 <p>Expert consensus supports reflex biomarker testing in G/GEJ adenocarcinoma to ensure that clinically relevant biomarker results are available at the time of initial oncology consultation, helping to facilitate timely treatment decisionâmaking and improve overall patient care. </p> 3955 3956</div> 3957 3958 3959 3960</div> 3961<div class="text bottom-space-s bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--neutral-500"> 3962<div data-cmp-data-layer="{"text-8e5ba431c7":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-19T22:08:29Z","xdm:text":"<h3>Initiation of Reflex Testing<sup>18</sup></h3>\n"}}" id="text-8e5ba431c7" class="cmp-text"> 3963 <h3>Initiation of Reflex Testing<sup>18</sup></h3> 3964 3965</div> 3966 3967 3968 3969</div> 3970<div class="text bottom-space-l text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 3971<div data-cmp-data-layer="{"text-c22226e1be":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T20:31:53Z","xdm:text":"<p>Consensus recommendations favor a pathologistâinitiated reflex testing approach, activated once diagnostic histology is confirmed, rather than waiting for a separate clinician request. This model is intended to streamline the diagnostic pathway and reduce avoidable delays in care.</p>\n"}}" id="text-c22226e1be" class="cmp-text"> 3972 <p>Consensus recommendations favor a pathologistâinitiated reflex testing approach, activated once diagnostic histology is confirmed, rather than waiting for a separate clinician request. This model is intended to streamline the diagnostic pathway and reduce avoidable delays in care.</p> 3973 3974</div> 3975 3976 3977 3978</div> 3979<div class="text bottom-space-s bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--neutral-500"> 3980<div data-cmp-data-layer="{"text-b0fcdb3cbc":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T22:22:05Z","xdm:text":"<h3>Biomarker Testing Approach<sup>18</sup></h3>"}}" id="text-b0fcdb3cbc" class="cmp-text"> 3981 <h3>Biomarker Testing Approach<sup>18</sup></h3> 3982</div> 3983 3984 3985 3986</div> 3987<div class="text bottom-space-xl text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 3988<div data-cmp-data-layer="{"text-44003ee900":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T20:32:58Z","xdm:text":"<p>Experts agreed that reflex testing should be considered based on tumor histology in patients with G/GEJ adenocarcinoma, with biomarker assessment coordinated as part of the initial diagnostic workâup.</p>\n"}}" id="text-44003ee900" class="cmp-text"> 3989 <p>Experts agreed that reflex testing should be considered based on tumor histology in patients with G/GEJ adenocarcinoma, with biomarker assessment coordinated as part of the initial diagnostic workâup.<
3989/p> 3990 3991</div> 3992 3993 3994 3995</div> 3996<div class="text bottom-space-s bold-styling step-1 cmp-weight-styles bold cmp-element__colorcode--neutral-500"> 3997<div data-cmp-data-layer="{"text-ddfe085ecd":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T22:22:12Z","xdm:text":"<h3>Operational Principles for Reflex Testing<sup>18</sup></h3>"}}" id="text-ddfe085ecd" class="cmp-text"> 3998 <h3>Operational Principles for Reflex Testing<sup>18</sup></h3> 3999</div> 4000 4001 4002 4003</div> 4004<div class="text bottom-space-s bold-styling step-0 cmp-weight-styles bold cmp-element__colorcode--neutral-500"> 4005<div data-cmp-data-layer="{"text-d9621bcbcd":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T20:34:41Z","xdm:text":"<h3>Bestâpractice implementation of reflex testing requires:</h3>\n"}}" id="text-d9621bcbcd" class="cmp-text"> 4006 <h3>Bestâpractice implementation of reflex testing requires:</h3> 4007 4008</div> 4009 4010 4011 4012</div> 4013<div class="text bottom-space-s text-styling step-0 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 4014<div data-cmp-data-layer="{"text-e3edcceb56":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T20:35:12Z","xdm:text":"<ul>\n<li>Coordination across the full tissue pathway, from biopsy acquisition through testing and reporting</li>\n<li>Use of standardized, qualityâassured laboratory processes to ensure accuracy and validity of results</li>\n<li>Pathology reports that provide clear, sufficiently detailed biomarker results to support downstream clinical decisionâmaking </li>\n</ul>\n"}}" id="text-e3edcceb56" class="cmp-text"> 4015 <ul><li>Coordination across the full tissue pathway, from biopsy acquisition through testing and reporting</li><li>Use of standardized, qualityâassured laboratory processes to ensure accuracy and validity of results</li><li>Pathology reports that provide clear, sufficiently detailed biomarker results to support downstream clinical decisionâmaking </li></ul> 4016 4017</div> 4018 4019 4020 4021</div> 4022<div class="container responsivegrid cmp-container-box-shadow cmp-container__padding cmp-corner-radius"> 4023 4024 4025 4026 4027 4028 4029 4030 4031 <div id="container-e1442d6bd4" class="cmp-container"> 4032 4033 <div class="text bottom-space-xl bold-styling step-3 cmp-weight-styles bold cmp-element__colorcode--page-title"> 4034<div data-cmp-data-layer="{"text-79eba01916":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-04T20:36:35Z","xdm:text":"<h2>&quot;Itâs critical that pathologists advocate for testing at diagnosis for all prevalent, actionable biomarkers.&quot;</h2>\n"}}" id="text-79eba01916" class="cmp-text"> 4035 <h2>"Itâs critical that pathologists advocate for testing at diagnosis for all prevalent, actionable biomarkers."</h2> 4036 4037</div> 4038 4039 4040 4041</div> 4042<div class="columncontainer responsivegrid slot-columncontainer cmp-columncontainer-v2"> 4043 <div id="columncontainer-36609688e0" class="cmp-columncontainer 4044 cmp-columncontainer--2col-3_1 cmp-columncontainer--spcol-cmp-follow--desktop 4045 cmp-columncontainer--tablet 4046 cmp-follow--desktop"> 4047 4048 4049 <div class="cmp-columncontainer-item"> 4050 4051 4052<div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> 4053 4054 4055 4056</div> 4057</div> 4058 4059 4060 <div class="cmp-columncontainer-item"> 4061 4062 4063<div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> 4064 4065 4066 4067</div> 4068</div> 4069 4070 </div> 4071</div> 4072<div class="illustrationset"> 4073 4074 4075 4076 <div class="cmp-illustration" data-cmp-data-layer="{"illustrationset-61cb9a2cdc":{"dc:description":"","repo:modifyDate":"2026-03-10T19:22:32Z","xdm:linkURL":"/content/claudin/hcp/north-america/us/en/prepare-and-test-samples","@type":"global/components/globalcomponents/illustrationset/v1/illustrationset","dc:title":""}}"> 4077 <div class="illustration-container card teaser xl-size cmp-radius-image cmp-remove-box-shadow cmp-remove-background remove-wrapper-padding"> 4078 4079 4080 4081 4082 4083 4084 4085 4086<div class="illustration-container__imgwrapper"> 4087 4088 4089 4090 4091 4092<div data-cmp-is="image" data-cmp-widths="400,600,800,1000,1200,1400,1800,2000" data-cmp-dmimage data-cmp-src="https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-dr-matteo-fassan-d?qlt=82&wid=%7B.width%7D&ts=1790348523570&dpr=off" data-asset-id="9a9e9dfe-c79c-4580-a29e-932da1b3a40c" id="illustration-container-e93faed395-image" 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600w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-dr-matteo-fassan-d?qlt=82&wid=800&ts=1790348523570&dpr=off 800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-dr-matteo-fassan-d?qlt=82&wid=1000&ts=1790348523570&dpr=off 1000w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-dr-matteo-fassan-d?qlt=82&wid=1200&ts=1790348523570&dpr=off 1200w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-dr-matteo-fassan-d?qlt=82&wid=1400&ts=1790348523570&dpr=off 1400w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-dr-matteo-fassan-d?qlt=82&wid=1800&ts=1790348523570&dpr=off 1800w,https://s7d1.scene7.com/is/image/astellasuat/cldn182-hcp-prepare-and-test-samples-dr-matteo-fassan-d?qlt=82&wid=2000&ts=1790348523570&dpr=off 2000w" loading="lazy" class="cmp-image__image" itemprop="contentUrl" width="408" height="408" alt="Profile photo of Dr. Matteo Fassan "/> 4094 4095 4096</div> 4097 4098 4099 4100 4101 4102 4103 <!-- Code embed Component--> 4104</div> 4105 4106<div class="illustration-container__content" id="illustration-container-e93faed395" data-cmp-data-layer="{"illustration-container-e93faed395":{"@type":"/apps/global/components/globalcomponents/illustration-container/v1/illustration-container","repo:modifyDate":"2026-09-04T01:34:04Z","dc:title":"<div class=\"cmp-element__colorcode--secondary-card-title\"><p>Â </p>\r\n<h3>Matteo Fassan, MD, PhD</h3>\r\n</div>\r\n"}}"> 4107 4108 4109 4110
4111 <!--jobcode--> 4112 4113 <!--kicker--> 4114 4115 4116 <div class="illustration-container__content--title cmp-element__colorcode--secondary-card-title" aria-label="<div class="cmp-element__colorcode--secondary-card-title"><p>Â </p> 4117<h3>Matteo Fassan, MD, PhD</h3> 4118</div> 4119"><span><div class="cmp-element__colorcode--secondary-card-title"><p>Â </p> 4120<h3>Matteo Fassan, MD, PhD</h3> 4121</div> 4122</span></div> 4123 4124 4125 <!-- Time & Date from comp dialog--> 4126 4127 <!-- Time & Date from page Properties--> 4128 4129 4130 4131 4132 4133 <!-- Card Reference Component--> 4134 4135</div></div> 4136 4137 4138 4139 4140 </div> 4141</div> 4142 4143 4144 </div> 4145 4146</div> 4147 4148 4149 </div> 4150 4151 4152</section></div> 4153<div class="container responsivegrid"> 4154 4155 4156 4157 4158 4159 4160 4161 4162 <div id="container-c4eea6f449" class="cmp-container" style="background:#F5F5F5;"> 4163 4164 <div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l top-padding-l"> 4165<section style=";"> 4166 4167 4168 4169 4170 4171 4172 4173 4174 4175 <div id="container-baf6f32c80" class="cmp-container"> 4176 4177 <div class="text bottom-space-m bold-styling step-4 cmp-weight-styles bold cmp-element__colorcode--page-title"> 4178<div data-cmp-data-layer="{"text-330d0645b1":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-10T19:38:24Z","xdm:text":"<h2>Learn more about interpreting CLDN18.2&nbsp;expression</h2>\r\n"}}" id="text-330d0645b1" class="cmp-text"> 4179 <h2>Learn more about interpreting CLDN18.2Â expression</h2> 4180 4181</div> 4182 4183 4184 4185</div> 4186<div class="global-link cmp-global-link-primary step-0"> 4187 4188 4189 4190 4191 <ul> 4192 <li> 4193 4194 4195 4196 <!-- Not dowload --> 4197 <a href="/stain-interpretation" data-cmp-data-layer="{"global-link-e15ff060b0-headerlink-item0null":{ 4198 "xdm:linkTarget" : "_self", 4199 "xdm:linkType" : "internal", 4200 "xdm:linkURL" : "/content/claudin/hcp/north-america/us/en/stain-interpretation", 4201 "@type" : "global/components/globalcomponents/navigation/global-link/v1/global-link/link", 4202 "dc:title" : "Stain Interpretation" 4203}}" target="_self" data-cmp-clickable> 4204 4205 <span>Stain Interpretation</span> 4206 4207 4208 </a> 4209 4210 4211 4212 4213 4214 4215 4216 4217 4218 4219 4220 4221 </li> 4222 </ul> 4223</div> 4224 4225 4226 </div> 4227 4228 4229</section></div> 4230 4231 4232 </div> 4233 4234</div> 4235<div class="section-container container responsivegrid cmp-full-width-section bottom-padding-l top-padding-l"> 4236<section style=";"> 4237 4238 4239 4240 4241 4242 4243 4244 4245 4246 <div id="container-55f45cdda3" class="cmp-container"> 4247 4248 <div class="text bottom-space-l text-styling step--1 cmp-weight-styles regular cmp-element__colorcode--neutral-500"> 4249<div data-cmp-data-layer="{"text-6f90b99a5f":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-06-15T17:07:02Z","xdm:text":"<p>CAP, College of American Pathologists; CLDN18, claudin 18; CLDN18.1, claudin 18 isoform 1; CLDN18.2, claudin 18 isoform 2; EQA, external quality assessment; GC, gastric cancer; G/GEJ, gastric/gastroesophageal junction; HER2, human epidermal growth factor receptor-2; IHC, immunohistochemistry; IVD, in vitro diagnostic; RUO, research use only.</p>\r\n"}}" id="text-6f90b99a5f" class="cmp-text"> 4250 <p>CAP, College of American Pathologists; CLDN18, claudin 18; CLDN18.1, claudin 18 isoform 1; CLDN18.2, claudin 18 isoform 2; EQA, external quality assessment; GC, gastric cancer; G/GEJ, gastric/gastroesophageal junction; HER2, human epidermal growth factor receptor-2; IHC, immunohistochemistry; IVD, in vitro diagnostic; RUO, research use only.</p> 4251 4252</div> 4253 4254 4255 4256</div> 4257<div class="text bottom-space-s text-styling step--1 cmp-weight-styles semi-bold cmp-element__colorcode--neutral-500"> 4258<div data-cmp-data-layer="{"text-937238250e":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-03-10T19:41:17Z","xdm:text":"<p>References:</p>\r\n"}}" id="text-937238250e" class="cmp-text"> 4259 <p>References:</p> 4260 4261</div> 4262 4263 4264 4265</div> 4266<div class="text text-styling step--1 cmp-weight-styles regular cmp-element__colorcode--neutral-500 cmp-reference--section cmp-reference--triple-number cmp-hyperlink--ondark cmp-custom-word-break"> 4267<div data-cmp-data-layer="{"text-bd9c72f038":{"@type":"global/components/globalcomponents/text/v1/text","repo:modifyDate":"2026-08-07T19:29:16Z","xdm:text":"<ul>\n<li><span class=\"cmp-weight-styles bold\">1.</span>Compton CC, Robb JA, Anderson MW, et al. Preanalytics and precision pathology: pathology practices to ensure molecular integrity of cancer patient biospecimens for precision medicine. <i>Arch Pathol Lab Med.</i> 2019;143(11):1346-1363.</li>\n<li><span class=\"cmp-weight-styles bold\">2.</span>Ventana CLDN18 (43-14A) RxDx assay. Package insert. Tucson, AZ: Ventana Medical Systems, Inc; 2024.</li>\n<li><span class=\"cmp-weight-styles bold\">3.</span>Sahin U, Koslowski M, Dhaene K, et al. Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development. <i>Clin Cancer Res.</i> 2008;14(23):7624-7634.</li>\n<li><span class=\"cmp-weight-styles bold\">4.</span>Hashimoto T, Iida N, Nakamura Y, et al. Landscape analysis of CLDN18 expression and isoform distribution in solid tumors: insights from MONSTAR-SCREEN-2 study. <i>Cancer Sci.</i> 2025;116(8):2218-2231.</li>\n<li><span class=\"cmp-weight-styles bold\">5.</span>
4267Sun Y, Puspanathan P, Lim T, Lin D. Advances and challenges in gastric cancer testing: the role of biomarkers. <i>Cancer Biol Med.</i> 2025;22(3):212-230.</li>\n<li><span class=\"cmp-weight-styles bold\">6.</span>Discovery Life Sciences. Recommended handling and storage for biological specimens. Published August 2023. Accessed June 30, 2026. https://dls.com/wp-content/uploads/2023/08/Recommended_Handling_and_Storage_for_Biological_Specimens_2020-2.pdf</li>\n<li><span class=\"cmp-weight-styles bold\">7.</span>Abcam. Anti-claudin18 antibody [43-14A]. Accessed July 8, 2026. https://doc.abcam.com/datasheets/active/ab314690/en-us/claudin18-antibody-43-14a-ab314690.pdf</li>\n<li><span class=\"cmp-weight-styles bold\">8.</span>LSBio. PathPlus CLDN18 Monoclonal Antibody Mouse IHC. Accessed July 15, 2026. https://www.lsbio.com/pathplus-antibodies/pathplus-cldn18-antibody-claudin-18-antibody-ihc-ls-b16145/789855#speci%EF%AC%81cations-section</li>\n<li><span class=\"cmp-weight-styles bold\">9.</span>Jasani B, Taniere P, Schildhaus HU, et al. Global Ring Study to investigate the comparability of total assay performance of commercial claudin18 antibodies for evaluation in gastric cancer [published online November 8, 2023]. <i>Lab Invest.</i> 2024. Accessed June 19, 2026. https://www.laboratoryinvestigation.org/action/showPdf?pii=S0023-6837%2823%2900227-1</li>\n<li><span class=\"cmp-weight-styles bold\">10.</span>Fitzgibbons PL, Bradley LA, Fatheree LA, et al. Principles of analytic validation of immunohistochemical assays: guideline from the College of American Pathologists Pathology and Laboratory Quality Center. <i>Arch Pathol Lab Med.</i> 2014;138(11):1432-1443.</li>\n<li><span class=\"cmp-weight-styles bold\">11.</span>Goldsmith JD, Troxell ML, Roy-Chowdhuri S, et al. Principles of analytic validation of immunohistochemical assays: guideline update. <i>Arch Pathol Lab Med.</i> 2024;148(6):e111-e153.</li>\n<li><span class=\"cmp-weight-styles bold\">12.</span>Coati I, Lotz G, Fanelli GN, et al. Claudin-18 expression in oesophagogastric adenocarcinomas: a tissue microarray study of 523 molecularly profiled cases. <i>Br J Cancer.</i> 2019;121(3):257-263.</li>\n<li><span class=\"cmp-weight-styles bold\">13.</span>Grillo F, Fassan M, Sarocchi F, et al. HER2 heterogeneity in gastric/gastroesophageal cancers: from benchside to practice. <i>World J Gastroenterol.</i> 2016;22(26):5879-5887.</li>\n<li><span class=\"cmp-weight-styles bold\">14.</span>Pellino A, Brignola S, Riello E, et al. Association of CLDN18 protein expression with clinicopathological features and prognosis in advanced gastric and gastroesophageal junction adenocarcinomas [published online October 26, 2021]. <i>J Pers Med.</i> 2021. Accessed April 3, 2026. https://www.mdpi.com/2075-4426/11/11/1095</li>\n<li><span class=\"cmp-weight-styles bold\">15.</span>Pak S, Simon AG, Lyu SI, et al. The expression of the tight junction protein and therapeutical target Claudin 18.2 is heterogeneously distributed within esophageal and gastric aden
4267ocarcinoma [published online August 7, 2025]. <i>Sci Rep.</i> 2025. Accessed June 19, 2026. https://www.nature.com/articles/s41598-025-12337-4</li>\n<li><span class=\"cmp-weight-styles bold\">16.</span>NordiQC. Assessment run C17 2025: Claudin 18.2 (CLDN18.2). Published April 7, 2025. Accessed June 19, 2026. https://www.nordiqc.org/downloads/assessments/206_123.pdf</li>\n<li><span class=\"cmp-weight-styles bold\">17.</span>NordiQC. About NordiQC. Accessed August 4, 2025. https://www.nordiqc.org/about.php</li>\n<li><span class=\"cmp-weight-styles bold\">18.</span>West NP, Mansoor W, Taniere P, et al. Best-practice biomarker testing of oesophago-GC in the UK: expert consensus recommendations developed using a modified Delphi. <i>Clin Oncol (R Coll Radiol).</i> 2024;36(11):701-709.</li>\n</ul>\n"}}" id="text-bd9c72f038" class="cmp-text"> 4268 <ul><li><span class="cmp-weight-styles bold">1.</span>Compton CC, Robb JA, Anderson MW, et al. Preanalytics and precision pathology: pathology practices to ensure molecular integrity of cancer patient biospecimens for precision medicine. <i>Arch Pathol Lab Med.</i> 2019;143(11):1346-1363.</li><li><span class="cmp-weight-styles bold">2.</span>Ventana CLDN18 (43-14A) RxDx assay. Package insert. Tucson, AZ: Ventana Medical Systems, Inc; 2024.</li><li><span class="cmp-weight-styles bold">3.</span>Sahin U, Koslowski M, Dhaene K, et al. Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development. <i>Clin Cancer Res.</i> 2008;14(23):7624-7634.</li><li><span class="cmp-weight-styles bold">4.</span>Hashimoto T, Iida N, Nakamura Y, et al. Landscape analysis of CLDN18 expression and isoform distribution in solid tumors: insights from MONSTAR-SCREEN-2 study. <i>Cancer Sci.</i> 2025;116(8):2218-2231.</li><li><span class="cmp-weight-styles bold">5.</span>Sun Y, Puspanathan P, Lim T, Lin D. Advances and challenges in gastric cancer testing: the role of biomarkers. <i>Cancer Biol Med.</i> 2025;22(3):212-230.</li><li><span class="cmp-weight-styles bold">6.</span>Discovery Life Sciences. Recommended handling and storage for biological specimens. Published August 2023. Accessed June 30, 2026. https://dls.com/wp-content/uploads/2023/08/Recommended_Handling_and_Storage_for_Biological_Specimens_2020-2.pdf</li><li><span class="cmp-weight-styles bold">7.</span>Abcam. Anti-claudin18 antibody [43-14A]. Accessed July 8, 2026. https://doc.abcam.com/datasheets/active/ab314690/en-us/claudin18-antibody-43-14a-ab314690.pdf</li><li><span class="cmp-weight-styles bold">8.</span>LSBio. PathPlus CLDN18 Monoclonal Antibody Mouse IHC. Accessed July 15, 2026. https://www.lsbio.com/pathplus-antibodies/pathplus-cldn18-antibody-claudin-18-antibody-ihc-ls-b16145/789855#speci%EF%AC%81cations-section</li><li><span class="cmp-weight-styles bold">
42689.</span>Jasani B, Taniere P, Schildhaus HU, et al. Global Ring Study to investigate the comparability of total assay performance of commercial claudin18 antibodies for evaluation in gastric cancer [published online November 8, 2023]. <i>Lab Invest.</i> 2024. Accessed June 19, 2026. https://www.laboratoryinvestigation.org/action/showPdf?pii=S0023-6837%2823%2900227-1</li><li><span class="cmp-weight-styles bold">10.</span>Fitzgibbons PL, Bradley LA, Fatheree LA, et al. Principles of analytic validation of immunohistochemical assays: guideline from the College of American Pathologists Pathology and Laboratory Quality Center. <i>Arch Pathol Lab Med.</i> 2014;138(11):1432-1443.</li><li><span class="cmp-weight-styles bold">11.</span>Goldsmith JD, Troxell ML, Roy-Chowdhuri S, et al. Principles of analytic validation of immunohistochemical assays: guideline update. <i>Arch Pathol Lab Med.</i> 2024;148(6):e111-e153.</li><li><span class="cmp-weight-styles bold">12.</span>Coati I, Lotz G, Fanelli GN, et al. Claudin-18 expression in oesophagogastric adenocarcinomas: a tissue microarray study of 523 molecularly profiled cases. <i>Br J Cancer.</i> 2019;121(3):257-263.</li><li><span class="cmp-weight-styles bold">13.</span>Grillo F, Fassan M, Sarocchi F, et al. HER2 heterogeneity in gastric/gastroesophageal cancers: from benchside to practice. <i>World J Gastroenterol.</i> 2016;22(26):5879-5887.</li><li><span class="cmp-weight-styles bold">14.</span>Pellino A, Brignola S, Riello E, et al. Association of CLDN18 protein expression with clinicopathological features and prognosis in advanced gastric and gastroesophageal junction adenocarcinomas [published online October 26, 2021]. <i>J Pers Med.</i> 2021. Accessed April 3, 2026. https://www.mdpi.com/2075-4426/11/11/1095</li><li><span class="cmp-weight-styles bold">15.</span>Pak S, Simon AG, Lyu SI, et al. The expression of the tight junction protein and therapeutical target Claudin 18.2 is heterogeneously distributed within esophageal and gastric aden
4268ocarcinoma [published online August 7, 2025]. <i>Sci Rep.</i> 2025. Accessed June 19, 2026. https://www.nature.com/articles/s41598-025-12337-4</li><li><span class="cmp-weight-styles bold">16.</span>NordiQC. Assessment run C17 2025: Claudin 18.2 (CLDN18.2). Published April 7, 2025. Accessed June 19, 2026. https://www.nordiqc.org/downloads/assessments/206_123.pdf</li><li><span class="cmp-weight-styles bold">17.</span>NordiQC. About NordiQC. Accessed August 4, 2025. https://www.nordiqc.org/about.php</li><li><span class="cmp-weight-styles bold">18.</span>West NP, Mansoor W, Taniere P, et al. Best-practice biomarker testing of oesophago-GC in the UK: expert consensus recommendations developed using a modified Delphi. <i>Clin Oncol (R Coll Radiol).</i> 2024;36(11):701-709.</li></ul> 4269 4270</div> 4271 4272 4273 4274</div> 4275<div class="code-embed"> 4276 4277 4278 <style> 4279 #text-95540eb0b6 ul { gap: 6px} 4280 4281</style> 4282</div> 4283 4284 4285 </div> 4286 4287 4288</section></div> 4289 4290 4291 </div> 4292 4293</div> 4294<div class="experience-fragment experiencefragment aem-GridColumn aem-GridColumn--default--12"> 4295<div class="cmp-experiencefragment cmp-experiencefragment--importantsafetyinformation cmp-experiencefragment--active"> 4296 <div class="cmp-modalcontainer__content"> 4297 4298 4299 4300 <div id="container-885f75c528" class="cmp-container"> 4301 4302 4303 4304<div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> 4305 4306 4307 4308</div> 4309 4310 </div> 4311 4312 4313</div> 4314</div> 4315 4316 4317 4318</div> 4319<div class="container 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