{"id":5779,"date":"2022-11-29T15:49:39","date_gmt":"2022-11-29T23:49:39","guid":{"rendered":"https:\/\/researchdx.com\/?page_id=5779"},"modified":"2025-09-26T15:24:18","modified_gmt":"2025-09-26T22:24:18","slug":"orthogonal-validation","status":"publish","type":"page","link":"https:\/\/researchdx.com\/orthogonal-validation\/","title":{"rendered":"Orthogonal Validations"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5779\" class=\"elementor elementor-5779\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-430cc4db e-flex e-con-boxed e-con e-parent\" data-id=\"430cc4db\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;opacity-tilt&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 2600 131.1\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M0 0L2600 0 2600 69.1 0 0z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.5\" d=\"M0 0L2600 0 2600 69.1 0 69.1z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.25\" d=\"M2600 0L0 0 0 130.1 2600 69.1z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-782b6122 elementor-widget elementor-widget-heading\" data-id=\"782b6122\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Orthogonal Validations<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-585df440 e-flex e-con-boxed e-con e-parent\" data-id=\"585df440\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3b891959 elementor-widget elementor-widget-text-editor\" data-id=\"3b891959\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We offer\u00a0<strong>orthogonal validation<\/strong>\u00a0to meet\u00a0<strong>analytical validation<\/strong>\u00a0requirements for regulatory filings. As a CDO (diagnostic-focused CRO), our team of experts has experience designing and executing studies to compare an assay with an independently validated orthogonal method for analytical accuracy\/concordance and platform validation.<\/p><p>ResearchDx can help with study design, representative sample selection, study execution, statistical analysis, reporting and GAP analysis to satisfy relevant regulatory requirements. Our clients include many of the biggest names in diagnostics.<\/p><p>We offer externally validated solutions across different technology types (NGS, Sanger, qPCR, ddPCR, FISH, etc.).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9f088b3 e-flex e-con-boxed e-con e-parent\" data-id=\"9f088b3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-feb633a e-con-full e-flex e-con e-child\" data-id=\"feb633a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-75df294 elementor-widget elementor-widget-text-editor\" data-id=\"75df294\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2>Orthogonal Comparator Methods<\/h2><ul class=\"wp-block-list\"><li>Multiple validated NGS Panels<\/li><li>Sanger Sequencing<\/li><li>qPCR \u2013 Commercial and custom solutions<\/li><li>ddPCR \u2013 Commercial and custom solutions<\/li><li>ELISA \u2013 Commercial and custom solutions<\/li><li>FACS \u2013 Custom solutions to fit your needs<\/li><li>Any commercially available assay, reagent or Kit.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c2908eb e-con-full e-flex e-con e-child\" data-id=\"c2908eb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8a9921e elementor-widget elementor-widget-text-editor\" data-id=\"8a9921e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2>Product Focus: PMA and 510(k) Reproducibility Studies<\/h2><p>ResearchDx has performed hundreds of studies on behalf of our clients. A selection of our expertise includes:<\/p><ul class=\"wp-block-list\"><li>Diagnostic Equipment Precision\/Reproducability studies, with comparison to orthogonal device<\/li><li>Diagnostic Assay Precision\/Reproducibility studies with comparison to orthogonal assay<\/li><li>Custom-developed orthogonal assays for unique and bespoke assay application<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-31bf57db e-flex e-con-boxed e-con e-parent\" data-id=\"31bf57db\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;opacity-tilt&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 2600 131.1\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M0 0L2600 0 2600 69.1 0 0z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.5\" d=\"M0 0L2600 0 2600 69.1 0 69.1z\"\/>\n\t<path class=\"elementor-shape-fill\" style=\"opacity:0.25\" d=\"M2600 0L0 0 0 130.1 2600 69.1z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d073cbd elementor-widget elementor-widget-testimonial\" data-id=\"2d073cbd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"testimonial.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-testimonial-wrapper\">\n\t\t\t\t\t\t\t<div class=\"elementor-testimonial-content\">ResearchDx has performed dozens of different studies involving orthogonal comparator methods in support of IVD submissions, demonstrating analytical accuracy, product launch validation and for comparative marketing purposes.<\/div>\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f40acb1 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"4f40acb1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/researchdx.com\/contact-researchdx\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact Us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Orthogonal Validations We offer\u00a0orthogonal validation\u00a0to meet\u00a0analytical validation\u00a0requirements for regulatory filings. As a CDO (diagnostic-focused CRO), our team of experts has experience designing and executing studies to compare an assay with an independently validated orthogonal method for analytical accuracy\/concordance and platform validation. ResearchDx can help with study design, representative sample selection, study execution, statistical analysis, reporting [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":9168,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-5779","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/pages\/5779","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/comments?post=5779"}],"version-history":[{"count":12,"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/pages\/5779\/revisions"}],"predecessor-version":[{"id":11545,"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/pages\/5779\/revisions\/11545"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/media\/9168"}],"wp:attachment":[{"href":"https:\/\/researchdx.com\/wp-json\/wp\/v2\/media?parent=5779"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}