{"id":61389,"date":"2023-10-19T10:27:41","date_gmt":"2023-10-19T08:27:41","guid":{"rendered":"https:\/\/cegat.com\/?p=61389"},"modified":"2025-02-07T10:26:20","modified_gmt":"2025-02-07T09:26:20","slug":"analytical-performance-evaluation-of-a-523-gene-ctdna-assay-for-next-generation-sequencing-based-comprehensive-tumor-profiling-in-liquid-biopsy-samples","status":"publish","type":"post","link":"https:\/\/cegat.com\/de\/analytical-performance-evaluation-of-a-523-gene-ctdna-assay-for-next-generation-sequencing-based-comprehensive-tumor-profiling-in-liquid-biopsy-samples\/","title":{"rendered":"Analytical performance evaluation of a 523-gene ctDNA assay for next generation sequencing-based comprehensive tumor profiling in liquid biopsy samples"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-font-size:24px;\"><p><span class=\"authors-list-item \">Johannes Harter<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>1<\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \">Eleonora Buth<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>2<\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \">Janina Johaenning<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>2<\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \">Florian Battke<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>2<\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \">Maria Kopp<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>2<\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \">Henning Zelba<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>3<\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \">Martin Schulze<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>3<\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \">Jiri Koedding<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>2<\/sup><span class=\"comma\">,\u00a0<\/span><\/span><span class=\"authors-list-item \">Saskia Biskup<sup class=\"affiliation-links\"><span class=\"author-sup-separator\">\u00a0<\/span>4<\/sup><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:60px;--awb-padding-bottom:60px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-custom_color_1);--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:36;line-height:var(--awb-typography1-line-height);\">Abstract<\/h2><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><p style=\"text-align: justify;\">Next-generation sequencing (NGS)-based comprehensive tumor profiling from liquid biopsy samples can significantly improve diagnosis and monitoring of tumors when high-quality tissue material is difficult to obtain. In addition, it offers the potential to capture the entire complexity of the tumor, which is particularly important for highly heterogeneous or metastatic tumors. Here we report the findings of an analytical performance evaluation of the Illumina TruSight Oncology 500 ctDNA assay, a 523-gene NGS panel developed for ctDNA-based comprehensive genomic profiling (CGP) of tumors, using reference and patient samples. Using 30 ng cfDNA, the assay showed high sensitivity and low variant detection variability for SNVs, indels, and fusions down to a VAF of 0.5% in the reference samples and VAFs, which were highly concordant with previous ddPCR results in the patient samples. At reduced input amounts (20, 15, and 5 ng) and below VAFs of 0.5%, sensitivity was considerably lower and variant detection variability increased. Covering 523 tumor-associated genes, the assay demonstrated a convincing performance comparable to NGS-based ctDNA assays with smaller gene panels, highlighting its value to screen large numbers of different genes.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--link_hover_color: var(--awb-color6);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:60px;--awb-padding-bottom:60px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-tabs fusion-tabs-1 classic vertical-tabs icon-position-left mobile-mode-carousel\" style=\"--awb-title-border-radius-top-left:0px;--awb-title-border-radius-top-right:0px;--awb-title-border-radius-bottom-right:0px;--awb-title-border-radius-bottom-left:0px;--awb-title-padding-top:10px;--awb-title-padding-right:50px;--awb-title-padding-bottom:10px;--awb-title-padding-left:50px;--awb-alignment:start;--awb-inactive-color:var(--awb-color7);--awb-title-text-color:var(--awb-color5);--awb-title-active-text-color:var(--awb-custom_color_1);--awb-background-color:var(--awb-color5);--awb-border-color:rgba(0,0,0,0.05);--awb-active-border-color:var(--awb-custom_color_1);\"><div class=\"nav\"><ul class=\"nav-tabs\" role=\"tablist\" aria-orientation=\"vertical\"><li class=\"active\" role=\"presentation\"><a class=\"tab-link\" data-toggle=\"tab\" role=\"tab\" aria-controls=\"tab-6e6cc87eb95cb1d4f83\" aria-selected=\"true\" tabindex=\"0\" id=\"fusion-tab-6e6cc87eb95cb1d4f83\" href=\"#tab-6e6cc87eb95cb1d4f83\"><h3 class=\"fusion-tab-heading\">Referenzen<\/h3><\/a><\/li><li  role=\"presentation\"><a class=\"tab-link\" data-toggle=\"tab\" role=\"tab\" aria-controls=\"tab-a9e4da2786b816af19b\" aria-selected=\"false\" tabindex=\"-1\" id=\"fusion-tab-a9e4da2786b816af19b\" href=\"#tab-a9e4da2786b816af19b\"><h3 class=\"fusion-tab-heading\">Autorinnen\/Autoren<\/h3><\/a><\/li><\/ul><\/div><div class=\"tab-content\"><div class=\"tab-pane fade fusion-clearfix in active\" role=\"tabpanel\" tabindex=\"0\" aria-labelledby=\"fusion-tab-6e6cc87eb95cb1d4f83\" id=\"tab-6e6cc87eb95cb1d4f83\">\n<p><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/37865292\/\" target=\"_blank\" rel=\"noopener\">Ver\u00f6ffentlichung auf NCBI anschauen<\/a><\/p>\n<p><a href=\"\/de\/diagnostik\/tumorerkrankungen\/\" target=\"_blank\" rel=\"noopener\"><span class=\"avia_iconbox_title\">Zu unserem Diagnostik-Portfolio f\u00fcr Tumorerkrankungen<\/span><\/a><\/p>\n<\/div><div class=\"tab-pane fade fusion-clearfix\" role=\"tabpanel\" tabindex=\"0\" aria-labelledby=\"fusion-tab-a9e4da2786b816af19b\" id=\"tab-a9e4da2786b816af19b\">\n<ol class=\"item-list\">\n<li id=\"full-view-affiliation-1\" data-affiliation-id=\"full-view-affiliation-1\">CeGaT GmbH, 72076 Tuebingen, Germany. Electronic address: Johannes.harter@cegat.de.<\/li>\n<li id=\"full-view-affiliation-2\" data-affiliation-id=\"full-view-affiliation-2\">CeGaT GmbH, 72076 Tuebingen, Germany.<\/li>\n<li id=\"full-view-affiliation-3\" data-affiliation-id=\"full-view-affiliation-3\">Center for Human Genetics Tuebingen, 72076 Tuebingen, Germany.<\/li>\n<li id=\"full-view-affiliation-4\" data-affiliation-id=\"full-view-affiliation-4\">CeGaT GmbH, 72076 Tuebingen, Germany; Center for Human Genetics Tuebingen, 72076 Tuebingen, Germany.<\/li>\n<\/ol>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":18,"featured_media":46347,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53],"tags":[258],"class_list":["post-61389","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-veroeffentlichungen","tag-tumorerkrankungen"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Analytical performance evaluation of a 523-gene ctDNA assay for next generation sequencing-based comprehensive tumor profiling in liquid biopsy samples<\/title>\n<meta name=\"description\" content=\"Diese sowie noch weitere Tumor-Publikationen, an denen wir mitgewirkt haben, k\u00f6nnen Sie auf unserer Website finden.\" \/>\n<meta name=\"robots\" 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