{"id":1641,"date":"2025-05-21T15:44:06","date_gmt":"2025-05-21T20:44:06","guid":{"rendered":"https:\/\/www.rqmplus.com\/?page_id=1641"},"modified":"2025-09-19T13:26:52","modified_gmt":"2025-09-19T18:26:52","slug":"companion-diagnostics-cdx","status":"publish","type":"page","link":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/","title":{"rendered":"Companion Diagnostics (CDx)"},"content":{"rendered":"<div id=\"rqm-divider-block_625b9d10a09a25edf8c1bab522845057\" class=\"block-rqm-divider rqm-dots-animate\" style=\"\">\n    <div class=\"rqm-divider\">\n        <div class=\"rqm-dots-divider\" style=\"display:flex;gap:19px;width:427px;\">\n    <svg class=\"rqm-dots\" viewBox=\"0 0 503.26 131.31\" aria-hidden=\"true\" height=\"40\" width=\"153\" style=\"display:block;\">\n        <g class=\"dots-start\" fill=\"#ffce06\">\n            <circle cx=\"65.65\" cy=\"65.65\" r=\"65.65\"\/>\n            <circle cx=\"251.63\" cy=\"65.65\" r=\"65.65\"\/>\n            <circle cx=\"437.61\" cy=\"65.65\" r=\"65.65\"\/>\n        <\/g>\n    <\/svg>\n    <svg class=\"rqm-dots-grad\" viewBox=\"0 0 823.14 131.31\" aria-hidden=\"true\" height=\"40\" width=\"255\" style=\"display:block; border-radius: 50px;\" preserveAspectRatio=\"xMaxYMid slice\">\n            <circle cx=\"65.65\" cy=\"65.65\" r=\"65.65\" fill=\"#ffce06\"\/>\n            <circle cx=\"71.4\" cy=\"65.65\" r=\"65.65\" fill=\"#ffcb08\"\/>\n            <circle cx=\"77.15\" cy=\"65.65\" r=\"65.65\" fill=\"#fec80b\"\/>\n            <circle cx=\"82.89\" cy=\"65.65\" r=\"65.65\" fill=\"#fec50d\"\/>\n            <circle cx=\"88.64\" cy=\"65.65\" r=\"65.65\" fill=\"#fdc20f\"\/>\n            <circle cx=\"94.39\" cy=\"65.65\" r=\"65.65\" fill=\"#fdc011\"\/>\n            <circle cx=\"100.13\" cy=\"65.65\" r=\"65.65\" fill=\"#fdbd12\"\/>\n            <circle cx=\"105.88\" cy=\"65.65\" r=\"65.65\" fill=\"#fcba14\"\/>\n            <circle cx=\"111.63\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb715\"\/>\n            <circle cx=\"117.37\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb416\"\/>\n            <circle cx=\"123.12\" cy=\"65.65\" r=\"65.65\" fill=\"#fbb117\"\/>\n            <circle cx=\"128.87\" cy=\"65.65\" r=\"65.65\" fill=\"#fbae18\"\/>\n            <circle cx=\"134.62\" cy=\"65.65\" r=\"65.65\" fill=\"#faac19\"\/>\n            <circle cx=\"140.36\" cy=\"65.65\" r=\"65.65\" fill=\"#faa919\"\/>\n            <circle cx=\"146.11\" cy=\"65.65\" r=\"65.65\" fill=\"#faa61a\"\/>\n            <circle cx=\"151.86\" cy=\"65.65\" r=\"65.65\" fill=\"#faa31b\"\/>\n            <circle cx=\"157.6\" cy=\"65.65\" r=\"65.65\" fill=\"#f9a01b\"\/>\n            <circle cx=\"163.35\" cy=\"65.65\" r=\"65.65\" fill=\"#f99e1c\"\/>\n            <circle cx=\"176.04\" cy=\"65.65\" r=\"65.65\" fill=\"#f99f1b\"\/>\n            <circle cx=\"191.05\" cy=\"65.65\" r=\"65.65\" fill=\"#faa21b\"\/>\n            <circle cx=\"206.06\" cy=\"65.65\" r=\"65.65\" fill=\"#faa41a\"\/>\n            <circle cx=\"221.06\" cy=\"65.65\" r=\"65.65\" fill=\"#faa719\"\/>\n            <circle cx=\"236.07\" cy=\"65.65\" r=\"65.65\" fill=\"#fbaa19\"\/>\n            <circle cx=\"251.07\" cy=\"65.65\" r=\"65.65\" fill=\"#fbad18\"\/>\n            <circle cx=\"266.08\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb017\"\/>\n            <circle cx=\"281.09\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb316\"\/>\n            <circle cx=\"296.09\" cy=\"65.65\" r=\"65.65\" fill=\"#fdb515\"\/>\n            <circle cx=\"167.34\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb315\"\/>\n            <circle cx=\"171.08\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb017\"\/>\n            <circle cx=\"174.82\" cy=\"65.65\" r=\"65.65\" fill=\"#fbad18\"\/>\n            <circle cx=\"178.56\" cy=\"65.65\" r=\"65.65\" fill=\"#fbaa19\"\/>\n            <circle cx=\"182.3\" cy=\"65.65\" r=\"65.65\" fill=\"#faa819\"\/>\n            <circle cx=\"186.05\" cy=\"65.65\" r=\"65.65\" fill=\"#faa51a\"\/>\n            <circle cx=\"189.79\" cy=\"65.65\" r=\"65.65\" fill=\"#faa21b\"\/>\n            <circle cx=\"193.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f99f1b\"\/>\n            <circle cx=\"197.27\" cy=\"65.65\" r=\"65.65\" fill=\"#f99c1c\"\/>\n            <circle cx=\"201.01\" cy=\"65.65\" r=\"65.65\" fill=\"#f8991d\"\/>\n            <circle cx=\"204.75\" cy=\"65.65\" r=\"65.65\" fill=\"#f8961d\"\/>\n            <circle cx=\"208.49\" cy=\"65.65\" r=\"65.65\" fill=\"#f7941d\"\/>\n            <circle cx=\"212.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f7911e\"\/>\n            <circle cx=\"215.97\" cy=\"65.65\" r=\"65.65\" fill=\"#f78e1e\"\/>\n            <circle cx=\"219.71\" cy=\"65.65\" r=\"65.65\" fill=\"#f68c1f\"\/>\n            <circle cx=\"223.46\" cy=\"65.65\" r=\"65.65\" fill=\"#f6891f\"\/>\n            <circle cx=\"227.2\" cy=\"65.65\" r=\"65.65\" fill=\"#f6861f\"\/>\n            <circle cx=\"230.94\" cy=\"65.65\" r=\"65.65\" fill=\"#f5831f\"\/>\n            <circle cx=\"234.68\" cy=\"65.65\" r=\"65.65\" fill=\"#f58020\"\/>\n            <circle cx=\"238.42\" cy=\"65.65\" r=\"65.65\" fill=\"#f57e20\"\/>\n            <circle cx=\"242.16\" cy=\"65.65\" r=\"65.65\" fill=\"#f47b20\"\/>\n            <circle cx=\"245.9\" cy=\"65.65\" r=\"65.65\" fill=\"#f47820\"\/>\n            <circle cx=\"249.64\" cy=\"65.65\" r=\"65.65\" fill=\"#f47521\"\/>\n            <circle cx=\"253.38\" cy=\"65.65\" r=\"65.65\" fill=\"#f37221\"\/>\n            <circle cx=\"257.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f36f21\"\/>\n            <circle cx=\"260.87\" cy=\"65.65\" r=\"65.65\" fill=\"#f36c21\"\/>\n            <circle cx=\"266.25\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"276.54\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"286.84\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"297.14\" cy=\"65.65\" r=\"65.65\" fill=\"#f37321\"\/>\n            <circle cx=\"307.44\" cy=\"65.65\" r=\"65.65\" fill=\"#f47621\"\/>\n            <circle cx=\"317.74\" cy=\"65.65\" r=\"65.65\" fill=\"#f47920\"\/>\n            <circle cx=\"328.04\" cy=\"65.65\" r=\"65.65\" fill=\"#f47c20\"\/>\n            <circle cx=\"338.34\" cy=\"65.65\" r=\"65.65\" fill=\"#f57f20\"\/>\n            <circle cx=\"348.63\" cy=\"65.65\" r=\"65.65\" fill=\"#f58120\"\/>\n            <circle cx=\"358.93\" cy=\"65.65\" r=\"65.65\" fill=\"#f5841f\"\/>\n            <circle cx=\"369.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f6871f\"\/>\n            <circle cx=\"379.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f68a1f\"\/>\n            <circle cx=\"389.83\" cy=\"65.65\" r=\"65.65\" fill=\"#f78c1e\"\/>\n            <circle cx=\"263.11\" cy=\"65.65\" r=\"65.65\" fill=\"#f78d1e\"\/>\n            <circle cx=\"268.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f68a1f\"\/>\n            <circle cx=\"273.15\" cy=\"65.65\" r=\"65.65\" fill=\"#f6871f\"\/>\n            <circle cx=\"278.17\" cy=\"65.65\" r=\"65.65\" fill=\"#f6851f\"\/>\n            <circle cx=\"283.19\" cy=\"65.65\" r=\"65.65\" fill=\"#f58220\"\/>\n            <circle cx=\"288.21\" cy=\"65.65\" r=\"65.65\" fill=\"#f57f20\"\/>\n            <circle cx=\"293.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f47c20\"\/>\n            <circle cx=\"298.25\" cy=\"65.65\" r=\"65.65\" fill=\"#f47920\"\/>\n            <circle cx=\"303.27\" cy=\"65.65\" r=\"65.65\" fill=\"#f47621\"\/>\n            <circle cx=\"308.29\" cy=\"65.65\" r=\"65.65\" fill=\"#f37321\"\/>\n            <circle cx=\"313.31\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"318.33\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"323.35\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"328.37\" cy=\"65.65\" r=\"65.65\" fill=\"#f26722\"\/>\n            <circle cx=\"333.39\" cy=\"65.65\" r=\"65.65\" fill=\"#f26322\"\/>\n            <circle cx=\"338.41\" cy=\"65.65\" r=\"65.65\" fill=\"#f16022\"\/>\n            <circle cx=\"343.43\" cy=\"65.65\" r=\"65.65\" fill=\"#f15d22\"\/>\n            <circle cx=\"348.45\" cy=\"65.65\" r=\"65.65\" fill=\"#f15922\"\/>\n            <circle cx=\"353.47\" cy=\"65.65\" r=\"65.65\" fill=\"#f15623\"\/>\n            <circle cx=\"358.49\" cy=\"65.65\" r=\"65.65\" fill=\"#f05223\"\/>\n            <circle cx=\"367.73\" cy=\"65.65\" r=\"65.65\" fill=\"#f05223\"\/>\n            <circle cx=\"381.2\" cy=\"65.65\" r=\"65.65\" fill=\"#f15523\"\/>\n            <circle cx=\"394.66\" cy=\"65.65\" r=\"65.65\" fill=\"#f15922\"\/>\n            <circle cx=\"408.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f15c22\"\/>\n            <circle cx=\"421.6\" cy=\"65.65\" r=\"65.65\" fill=\"#f16022\"\/>\n            <circle cx=\"435.07\" cy=\"65.65\" r=\"65.65\" fill=\"#f26322\"\/>\n            <circle cx=\"448.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f26622\"\/>\n            <circle cx=\"462\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"475.47\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"488.93\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"363.19\" cy=\"65.65\" r=\"65.65\" fill=\"#e77625\"\/>\n            <circle cx=\"368.1\" cy=\"65.65\" r=\"65.65\" fill=\"#e87326\"\/>\n            <circle cx=\"372.99\" cy=\"65.65\" r=\"65.65\" fill=\"#e87027\"\/>\n            <circle cx=\"377.89\" cy=\"65.65\" r=\"65.65\" fill=\"#e86e28\"\/>\n            <circle cx=\"382.78\" cy=\"65.65\" r=\"65.65\" fill=\"#e86b29\"\/>\n            <circle cx=\"387.68\" cy=\"65.65\" r=\"65.65\" fill=\"#e9682b\"\/>\n            <circle cx=\"392.57\" cy=\"65.65\" r=\"65.65\" fill=\"#e9652c\"\/>\n            <circle cx=\"397.47\" cy=\"65.65\" r=\"65.65\" fill=\"#e9612d\"\/>\n            <circle cx=\"402.37\" cy=\"65.65\" r=\"65.65\" fill=\"#e95e2e\"\/>\n            <circle cx=\"409.71\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5930\"\/>\n            <circle cx=\"414.6\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5631\"\/>\n            <circle cx=\"419.5\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5232\"\/>\n            <circle cx=\"424.4\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4e33\"\/>\n            <circle cx=\"428.07\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4b33\"\/>\n            <circle cx=\"432.97\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4734\"\/>\n            <circle cx=\"437.86\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4335\"\/>\n            <circle cx=\"442.76\" cy=\"65.65\" r=\"65.65\" fill=\"#ec3f36\"\/>\n            <circle cx=\"447.66\" cy=\"65.65\" r=\"65.65\" fill=\"#ed3a37\"\/>\n            <circle cx=\"452.55\" cy=\"65.65\" r=\"65.65\" fill=\"#ed3537\"\/>\n            <circle cx=\"457.45\" cy=\"65.65\" r=\"65.65\" fill=\"#ee2f38\"\/>\n            <circle cx=\"464.07\" cy=\"65.65\" r=\"65.65\" fill=\"#ee2f39\"\/>\n            <circle cx=\"472.4\" cy=\"65.65\" r=\"65.65\" fill=\"#ee353c\"\/>\n            <circle cx=\"480.74\" cy=\"65.65\" r=\"65.65\" fill=\"#ef3a3e\"\/>\n            <circle cx=\"489.08\" cy=\"65.65\" r=\"65.65\" fill=\"#ef3f40\"\/>\n            <circle cx=\"497.41\" cy=\"65.65\" r=\"65.65\" fill=\"#ef4342\"\/>\n            <circle cx=\"505.75\" cy=\"65.65\" r=\"65.65\" fill=\"#ef4744\"\/>\n            <circle cx=\"514.09\" cy=\"65.65\" r=\"65.65\" fill=\"#f04b47\"\/>\n            <circle cx=\"522.43\" cy=\"65.65\" r=\"65.65\" fill=\"#f04f49\"\/>\n            <circle cx=\"530.76\" cy=\"65.65\" r=\"65.65\" fill=\"#f0534b\"\/>\n            <circle cx=\"539.1\" cy=\"65.65\" r=\"65.65\" fill=\"#f1574e\"\/>\n            <circle cx=\"547.44\" cy=\"65.65\" r=\"65.65\" fill=\"#f15b50\"\/>\n            <circle cx=\"555.77\" cy=\"65.65\" r=\"65.65\" fill=\"#f15e53\"\/>\n            <circle cx=\"564.11\" cy=\"65.65\" r=\"65.65\" fill=\"#f16255\"\/>\n            <circle cx=\"572.45\" cy=\"65.65\" r=\"65.65\" fill=\"#f26558\"\/>\n            <circle cx=\"580.78\" cy=\"65.65\" r=\"65.65\" fill=\"#f2695a\"\/>\n            <circle cx=\"589.12\" cy=\"65.65\" r=\"65.65\" fill=\"#f26c5d\"\/>\n            <circle cx=\"462.4\" cy=\"65.65\" r=\"65.65\" fill=\"#f26b5d\"\/>\n            <circle cx=\"467.91\" cy=\"65.65\" r=\"65.65\" fill=\"#f1685d\"\/>\n            <circle cx=\"473.41\" cy=\"65.65\" r=\"65.65\" fill=\"#f0645c\"\/>\n            <circle cx=\"478.92\" cy=\"65.65\" r=\"65.65\" fill=\"#ef615c\"\/>\n            <circle cx=\"484.43\" cy=\"65.65\" r=\"65.65\" fill=\"#ef5d5c\"\/>\n            <circle cx=\"489.94\" cy=\"65.65\" r=\"65.65\" fill=\"#ee595b\"\/>\n            <circle cx=\"495.45\" cy=\"65.65\" r=\"65.65\" fill=\"#ed565b\"\/>\n            <circle cx=\"500.95\" cy=\"65.65\" r=\"65.65\" fill=\"#ed525a\"\/>\n            <circle cx=\"506.46\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4e5a\"\/>\n            <circle cx=\"511.97\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4959\"\/>\n            <circle cx=\"517.48\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4559\"\/>\n            <circle cx=\"522.99\" cy=\"65.65\" r=\"65.65\" fill=\"#ea4159\"\/>\n            <circle cx=\"528.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3c58\"\/>\n            <circle cx=\"534\" cy=\"65.65\" r=\"65.65\" fill=\"#e93758\"\/>\n            <circle cx=\"539.51\" cy=\"65.65\" r=\"65.65\" fill=\"#e83157\"\/>\n            <circle cx=\"545.02\" cy=\"65.65\" r=\"65.65\" fill=\"#e82b57\"\/>\n            <circle cx=\"550.53\" cy=\"65.65\" r=\"65.65\" fill=\"#e72456\"\/>\n            <circle cx=\"556.03\" cy=\"65.65\" r=\"65.65\" fill=\"#e71d56\"\/>\n            <circle cx=\"562.19\" cy=\"65.65\" r=\"65.65\" fill=\"#e71b57\"\/>\n            <circle cx=\"569.01\" cy=\"65.65\" r=\"65.65\" fill=\"#e72059\"\/>\n            <circle cx=\"575.84\" cy=\"65.65\" r=\"65.65\" fill=\"#e8255b\"\/>\n            <circle cx=\"582.66\" cy=\"65.65\" r=\"65.65\" fill=\"#e82a5d\"\/>\n            <circle cx=\"589.48\" cy=\"65.65\" r=\"65.65\" fill=\"#e82e5f\"\/>\n            <circle cx=\"596.3\" cy=\"65.65\" r=\"65.65\" fill=\"#e93261\"\/>\n            <circle cx=\"603.12\" cy=\"65.65\" r=\"65.65\" fill=\"#e93664\"\/>\n            <circle cx=\"609.94\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3966\"\/>\n            <circle cx=\"616.76\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3c68\"\/>\n            <circle cx=\"623.58\" cy=\"65.65\" r=\"65.65\" fill=\"#eb406a\"\/>\n            <circle cx=\"630.4\" cy=\"65.65\" r=\"65.65\" fill=\"#eb436d\"\/>\n            <circle cx=\"637.22\" cy=\"65.65\" r=\"65.65\" fill=\"#ec466f\"\/>\n            <circle cx=\"644.04\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4972\"\/>\n            <circle cx=\"650.86\" cy=\"65.65\" r=\"65.65\" fill=\"#ed4c74\"\/>\n            <circle cx=\"657.68\" cy=\"65.65\" r=\"65.65\" fill=\"#ed4e77\"\/>\n            <circle cx=\"664.5\" cy=\"65.65\" r=\"65.65\" fill=\"#ee5179\"\/>\n            <circle cx=\"671.32\" cy=\"65.65\" r=\"65.65\" fill=\"#ee547c\"\/>\n            <circle cx=\"678.14\" cy=\"65.65\" r=\"65.65\" fill=\"#ef577e\"\/>\n            <circle cx=\"684.96\" cy=\"65.65\" r=\"65.65\" fill=\"#f05981\"\/>\n            <circle cx=\"558.52\" cy=\"65.65\" r=\"65.65\" fill=\"#f05b83\"\/>\n            <circle cx=\"567.62\" cy=\"65.65\" r=\"65.65\" fill=\"#ed5781\"\/>\n            <circle cx=\"576.72\" cy=\"65.65\" r=\"65.65\" fill=\"#eb5380\"\/>\n            <circle cx=\"585.81\" cy=\"65.65\" r=\"65.65\" fill=\"#e94f7e\"\/>\n            <circle cx=\"594.91\" cy=\"65.65\" r=\"65.65\" fill=\"#e74b7d\"\/>\n            <circle cx=\"604.01\" cy=\"65.65\" r=\"65.65\" fill=\"#e5467b\"\/>\n            <circle cx=\"613.11\" cy=\"65.65\" r=\"65.65\" fill=\"#e34279\"\/>\n            <circle cx=\"622.21\" cy=\"65.65\" r=\"65.65\" fill=\"#e13d78\"\/>\n            <circle cx=\"631.31\" cy=\"65.65\" r=\"65.65\" fill=\"#e03977\"\/>\n            <circle cx=\"640.4\" cy=\"65.65\" r=\"65.65\" fill=\"#de3375\"\/>\n            <circle cx=\"649.5\" cy=\"65.65\" r=\"65.65\" fill=\"#dc2e74\"\/>\n            <circle cx=\"658.6\" cy=\"65.65\" r=\"65.65\" fill=\"#db2772\"\/>\n            <circle cx=\"667.7\" cy=\"65.65\" r=\"65.65\" fill=\"#d92171\"\/>\n            <circle cx=\"676.8\" cy=\"65.65\" r=\"65.65\" fill=\"#d71970\"\/>\n            <circle cx=\"682.15\" cy=\"65.65\" r=\"65.65\" fill=\"#d81a71\"\/>\n            <circle cx=\"686.25\" cy=\"65.65\" r=\"65.65\" fill=\"#d91e73\"\/>\n            <circle cx=\"690.35\" cy=\"65.65\" r=\"65.65\" fill=\"#da2275\"\/>\n            <circle cx=\"694.45\" cy=\"65.65\" r=\"65.65\" fill=\"#db2577\"\/>\n            <circle cx=\"698.55\" cy=\"65.65\" r=\"65.65\" fill=\"#dc2979\"\/>\n            <circle cx=\"702.65\" cy=\"65.65\" r=\"65.65\" fill=\"#dd2c7b\"\/>\n            <circle cx=\"706.75\" cy=\"65.65\" r=\"65.65\" fill=\"#df2f7d\"\/>\n            <circle cx=\"710.85\" cy=\"65.65\" r=\"65.65\" fill=\"#e03280\"\/>\n            <circle cx=\"714.95\" cy=\"65.65\" r=\"65.65\" fill=\"#e13582\"\/>\n            <circle cx=\"719.05\" cy=\"65.65\" r=\"65.65\" fill=\"#e23884\"\/>\n            <circle cx=\"723.15\" cy=\"65.65\" r=\"65.65\" fill=\"#e33b87\"\/>\n            <circle cx=\"727.25\" cy=\"65.65\" r=\"65.65\" fill=\"#e43e89\"\/>\n            <circle cx=\"731.35\" cy=\"65.65\" r=\"65.65\" fill=\"#e5408b\"\/>\n            <circle cx=\"735.45\" cy=\"65.65\" r=\"65.65\" fill=\"#e6438e\"\/>\n            <circle cx=\"739.55\" cy=\"65.65\" r=\"65.65\" fill=\"#e84690\"\/>\n            <circle cx=\"743.65\" cy=\"65.65\" r=\"65.65\" fill=\"#e94893\"\/>\n            <circle cx=\"747.75\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4b96\"\/>\n            <circle cx=\"751.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4e99\"\/>\n            <circle cx=\"757.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ef509d\"\/>\n    <\/svg>\n<\/div>\n\n        \n    <\/div>\n    <div class=\"rqm-divider-mobile\">\n        <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/rqm-dots-mobile.avif\" alt=\"\" width=\"427\" height=\"40\" \/>\n    <\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px\">\n<p>RQM+ delivers integrated and tailored regulatory, clinical, and market access support for <strong>pharmaceutical sponsors, biotech companies, and diagnostic developers<\/strong> advancing companion diagnostics (CDx) and precision medicine.<\/p>\n\n\n\n<p>Whether your goal is full commercial launch or obtaining the right regulatory clearance to support therapeutic clinical trials \u2014 such as IVDR compliance for performance studies in the EU \u2014 our MedTech experts provide fully integrated solutions to streamline approvals and align with drug development timelines.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"\/contact\">Start Now&nbsp;<\/a><\/div>\n<\/div>\n<\/div>\n\n\n<section id=\"content-list-block_6f6a25444014f36e6ca850a923dc962c\" class=\"block-content-list alignwide has-image\">\n    \n    <style>\n                #content-list-block_6f6a25444014f36e6ca850a923dc962c .clb-image {\n            background: url(https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/scientist-examining-samples-with-a-microscope-in-a-laboratory-setting.-5726835-2048x1152-1.webp) center center \/ cover no-repeat;\n        }\n            <\/style>\n\n\n    <div class=\"content-list-block-container\">\n        <div class=\"clb-bg clb-bg-1\"><\/div>\n        <div class=\"clb-bg clb-bg-2\"><\/div>\n        <div class=\"clb-inside\">\n            \n            <div class=\"clb-header\">\n                \n\n<h2 class=\"wp-block-heading pink-header has-pink-color has-text-color has-link-color wp-elements-f07ea21fdf7cb0e271433626c7449372\"><strong><strong><strong><strong>Why RQM+ for CDx?<\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n            <\/div>\n            <div class=\"clb-list\">\n                <div class=\"wp-block-columns\">\n                    <div class=\"wp-block-column\">\n    \n                        <ul>\n                                                                \n                                        \n                                    <li id=\"content-list-block_6f6a25444014f36e6ca850a923dc962c-row-0\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/med-device.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">MedTech-Only CRO<\/h3>\n                                            <p class=\"list-text\">100% focused on diagnostics and medical devices, with deep expertise in the co-development of companion diagnostics alongside therapeutic products.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_6f6a25444014f36e6ca850a923dc962c-row-1\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/test-tube-circle.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Therapeutic Alignment <\/h3>\n                                            <p class=\"list-text\">Deep experience with CDER\/CDRH, EMA, and IVDR co-development strategy.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_6f6a25444014f36e6ca850a923dc962c-row-2\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/playbook.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Integrated RA\/QA\/CA\/CRO Services <\/h3>\n                                            <p class=\"list-text\">Regulatory, clinical, and reimbursement support aligned with your drug partner\u2019s timelines.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_6f6a25444014f36e6ca850a923dc962c-row-3\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/checkmark.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Global Compliance Experts<\/h3>\n                                            <p class=\"list-text\">U.S. FDA, EU IVDR, UKCA, and country-specific CDx frameworks (e.g., Japan PMDA).<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_6f6a25444014f36e6ca850a923dc962c-row-4\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/RQM-Icon-White-Outline_3.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Flexible Engagement Models<\/h3>\n                                            <p class=\"list-text\">Support for both commercial CDx approval and investigational-use-only strategies in the U.S., EU, and global markets.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                        <\/ul>\n    \n                    <\/div>\n                                            <div class=\"wp-block-column\" style=\"flex-basis: 40%;\">\n                            <div class=\"clb-image-contain\">\n                                <div class=\"clb-image clb-img-echo\"><\/div>\n                            <\/div>\n                        <\/div>\n                                        \n                <\/div>\n            <\/div>\n            \n        <\/div>\n        \n    <\/div>\n<\/section>\n\n\n<div id=\"rqm-group-block_3ae0e15d064daa62c2e46f29f3854ce4\" class=\"block-rqm-group alignfull\" style=\"background-image: url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-left.avif');background-position: left top -30em;\">\n\n    <div class=\"rqm-group-content\">\n        \n    <\/div>\n\n<\/div>\n\n\n\n<div class=\"wp-block-group alignwide has-border-color has-pink-border-color is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px\"><div id=\"benefits\" class=\"block-rqm-heading rqm-dots-animate\">\n    <div class=\"rqm-heading\">\n        <div class=\"rqm-dots-divider\" style=\"display:flex;gap:50px;width:1253px;\">\n    <svg class=\"rqm-dots\" viewBox=\"0 0 503.26 131.31\" aria-hidden=\"true\" height=\"118\" width=\"451\" style=\"display:block;\">\n        <g class=\"dots-start\" fill=\"#ffce06\">\n            <circle cx=\"65.65\" cy=\"65.65\" r=\"65.65\"\/>\n            <circle cx=\"251.63\" cy=\"65.65\" r=\"65.65\"\/>\n            <circle cx=\"437.61\" cy=\"65.65\" r=\"65.65\"\/>\n        <\/g>\n    <\/svg>\n    <svg class=\"rqm-dots-grad\" viewBox=\"0 0 823.14 131.31\" aria-hidden=\"true\" height=\"118\" width=\"752\" style=\"display:block; border-radius: 50px;\" preserveAspectRatio=\"xMaxYMid slice\">\n            <circle cx=\"65.65\" cy=\"65.65\" r=\"65.65\" fill=\"#ffce06\"\/>\n            <circle cx=\"71.4\" cy=\"65.65\" r=\"65.65\" fill=\"#ffcb08\"\/>\n            <circle cx=\"77.15\" cy=\"65.65\" r=\"65.65\" fill=\"#fec80b\"\/>\n            <circle cx=\"82.89\" cy=\"65.65\" r=\"65.65\" fill=\"#fec50d\"\/>\n            <circle cx=\"88.64\" cy=\"65.65\" r=\"65.65\" fill=\"#fdc20f\"\/>\n            <circle cx=\"94.39\" cy=\"65.65\" r=\"65.65\" fill=\"#fdc011\"\/>\n            <circle cx=\"100.13\" cy=\"65.65\" r=\"65.65\" fill=\"#fdbd12\"\/>\n            <circle cx=\"105.88\" cy=\"65.65\" r=\"65.65\" fill=\"#fcba14\"\/>\n            <circle cx=\"111.63\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb715\"\/>\n            <circle cx=\"117.37\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb416\"\/>\n            <circle cx=\"123.12\" cy=\"65.65\" r=\"65.65\" fill=\"#fbb117\"\/>\n            <circle cx=\"128.87\" cy=\"65.65\" r=\"65.65\" fill=\"#fbae18\"\/>\n            <circle cx=\"134.62\" cy=\"65.65\" r=\"65.65\" fill=\"#faac19\"\/>\n            <circle cx=\"140.36\" cy=\"65.65\" r=\"65.65\" fill=\"#faa919\"\/>\n            <circle cx=\"146.11\" cy=\"65.65\" r=\"65.65\" fill=\"#faa61a\"\/>\n            <circle cx=\"151.86\" cy=\"65.65\" r=\"65.65\" fill=\"#faa31b\"\/>\n            <circle cx=\"157.6\" cy=\"65.65\" r=\"65.65\" fill=\"#f9a01b\"\/>\n            <circle cx=\"163.35\" cy=\"65.65\" r=\"65.65\" fill=\"#f99e1c\"\/>\n            <circle cx=\"176.04\" cy=\"65.65\" r=\"65.65\" fill=\"#f99f1b\"\/>\n            <circle cx=\"191.05\" cy=\"65.65\" r=\"65.65\" fill=\"#faa21b\"\/>\n            <circle cx=\"206.06\" cy=\"65.65\" r=\"65.65\" fill=\"#faa41a\"\/>\n            <circle cx=\"221.06\" cy=\"65.65\" r=\"65.65\" fill=\"#faa719\"\/>\n            <circle cx=\"236.07\" cy=\"65.65\" r=\"65.65\" fill=\"#fbaa19\"\/>\n            <circle cx=\"251.07\" cy=\"65.65\" r=\"65.65\" fill=\"#fbad18\"\/>\n            <circle cx=\"266.08\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb017\"\/>\n            <circle cx=\"281.09\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb316\"\/>\n            <circle cx=\"296.09\" cy=\"65.65\" r=\"65.65\" fill=\"#fdb515\"\/>\n            <circle cx=\"167.34\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb315\"\/>\n            <circle cx=\"171.08\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb017\"\/>\n            <circle cx=\"174.82\" cy=\"65.65\" r=\"65.65\" fill=\"#fbad18\"\/>\n            <circle cx=\"178.56\" cy=\"65.65\" r=\"65.65\" fill=\"#fbaa19\"\/>\n            <circle cx=\"182.3\" cy=\"65.65\" r=\"65.65\" fill=\"#faa819\"\/>\n            <circle cx=\"186.05\" cy=\"65.65\" r=\"65.65\" fill=\"#faa51a\"\/>\n            <circle cx=\"189.79\" cy=\"65.65\" r=\"65.65\" fill=\"#faa21b\"\/>\n            <circle cx=\"193.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f99f1b\"\/>\n            <circle cx=\"197.27\" cy=\"65.65\" r=\"65.65\" fill=\"#f99c1c\"\/>\n            <circle cx=\"201.01\" cy=\"65.65\" r=\"65.65\" fill=\"#f8991d\"\/>\n            <circle cx=\"204.75\" cy=\"65.65\" r=\"65.65\" fill=\"#f8961d\"\/>\n            <circle cx=\"208.49\" cy=\"65.65\" r=\"65.65\" fill=\"#f7941d\"\/>\n            <circle cx=\"212.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f7911e\"\/>\n            <circle cx=\"215.97\" cy=\"65.65\" r=\"65.65\" fill=\"#f78e1e\"\/>\n            <circle cx=\"219.71\" cy=\"65.65\" r=\"65.65\" fill=\"#f68c1f\"\/>\n            <circle cx=\"223.46\" cy=\"65.65\" r=\"65.65\" fill=\"#f6891f\"\/>\n            <circle cx=\"227.2\" cy=\"65.65\" r=\"65.65\" fill=\"#f6861f\"\/>\n            <circle cx=\"230.94\" cy=\"65.65\" r=\"65.65\" fill=\"#f5831f\"\/>\n            <circle cx=\"234.68\" cy=\"65.65\" r=\"65.65\" fill=\"#f58020\"\/>\n            <circle cx=\"238.42\" cy=\"65.65\" r=\"65.65\" fill=\"#f57e20\"\/>\n            <circle cx=\"242.16\" cy=\"65.65\" r=\"65.65\" fill=\"#f47b20\"\/>\n            <circle cx=\"245.9\" cy=\"65.65\" r=\"65.65\" fill=\"#f47820\"\/>\n            <circle cx=\"249.64\" cy=\"65.65\" r=\"65.65\" fill=\"#f47521\"\/>\n            <circle cx=\"253.38\" cy=\"65.65\" r=\"65.65\" fill=\"#f37221\"\/>\n            <circle cx=\"257.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f36f21\"\/>\n            <circle cx=\"260.87\" cy=\"65.65\" r=\"65.65\" fill=\"#f36c21\"\/>\n            <circle cx=\"266.25\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"276.54\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"286.84\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"297.14\" cy=\"65.65\" r=\"65.65\" fill=\"#f37321\"\/>\n            <circle cx=\"307.44\" cy=\"65.65\" r=\"65.65\" fill=\"#f47621\"\/>\n            <circle cx=\"317.74\" cy=\"65.65\" r=\"65.65\" fill=\"#f47920\"\/>\n            <circle cx=\"328.04\" cy=\"65.65\" r=\"65.65\" fill=\"#f47c20\"\/>\n            <circle cx=\"338.34\" cy=\"65.65\" r=\"65.65\" fill=\"#f57f20\"\/>\n            <circle cx=\"348.63\" cy=\"65.65\" r=\"65.65\" fill=\"#f58120\"\/>\n            <circle cx=\"358.93\" cy=\"65.65\" r=\"65.65\" fill=\"#f5841f\"\/>\n            <circle cx=\"369.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f6871f\"\/>\n            <circle cx=\"379.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f68a1f\"\/>\n            <circle cx=\"389.83\" cy=\"65.65\" r=\"65.65\" fill=\"#f78c1e\"\/>\n            <circle cx=\"263.11\" cy=\"65.65\" r=\"65.65\" fill=\"#f78d1e\"\/>\n            <circle cx=\"268.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f68a1f\"\/>\n            <circle cx=\"273.15\" cy=\"65.65\" r=\"65.65\" fill=\"#f6871f\"\/>\n            <circle cx=\"278.17\" cy=\"65.65\" r=\"65.65\" fill=\"#f6851f\"\/>\n            <circle cx=\"283.19\" cy=\"65.65\" r=\"65.65\" fill=\"#f58220\"\/>\n            <circle cx=\"288.21\" cy=\"65.65\" r=\"65.65\" fill=\"#f57f20\"\/>\n            <circle cx=\"293.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f47c20\"\/>\n            <circle cx=\"298.25\" cy=\"65.65\" r=\"65.65\" fill=\"#f47920\"\/>\n            <circle cx=\"303.27\" cy=\"65.65\" r=\"65.65\" fill=\"#f47621\"\/>\n            <circle cx=\"308.29\" cy=\"65.65\" r=\"65.65\" fill=\"#f37321\"\/>\n            <circle cx=\"313.31\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"318.33\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"323.35\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"328.37\" cy=\"65.65\" r=\"65.65\" fill=\"#f26722\"\/>\n            <circle cx=\"333.39\" cy=\"65.65\" r=\"65.65\" fill=\"#f26322\"\/>\n            <circle cx=\"338.41\" cy=\"65.65\" r=\"65.65\" fill=\"#f16022\"\/>\n            <circle cx=\"343.43\" cy=\"65.65\" r=\"65.65\" fill=\"#f15d22\"\/>\n            <circle cx=\"348.45\" cy=\"65.65\" r=\"65.65\" fill=\"#f15922\"\/>\n            <circle cx=\"353.47\" cy=\"65.65\" r=\"65.65\" fill=\"#f15623\"\/>\n            <circle cx=\"358.49\" cy=\"65.65\" r=\"65.65\" fill=\"#f05223\"\/>\n            <circle cx=\"367.73\" cy=\"65.65\" r=\"65.65\" fill=\"#f05223\"\/>\n            <circle cx=\"381.2\" cy=\"65.65\" r=\"65.65\" fill=\"#f15523\"\/>\n            <circle cx=\"394.66\" cy=\"65.65\" r=\"65.65\" fill=\"#f15922\"\/>\n            <circle cx=\"408.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f15c22\"\/>\n            <circle cx=\"421.6\" cy=\"65.65\" r=\"65.65\" fill=\"#f16022\"\/>\n            <circle cx=\"435.07\" cy=\"65.65\" r=\"65.65\" fill=\"#f26322\"\/>\n            <circle cx=\"448.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f26622\"\/>\n            <circle cx=\"462\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"475.47\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"488.93\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"363.19\" cy=\"65.65\" r=\"65.65\" fill=\"#e77625\"\/>\n            <circle cx=\"368.1\" cy=\"65.65\" r=\"65.65\" fill=\"#e87326\"\/>\n            <circle cx=\"372.99\" cy=\"65.65\" r=\"65.65\" fill=\"#e87027\"\/>\n            <circle cx=\"377.89\" cy=\"65.65\" r=\"65.65\" fill=\"#e86e28\"\/>\n            <circle cx=\"382.78\" cy=\"65.65\" r=\"65.65\" fill=\"#e86b29\"\/>\n            <circle cx=\"387.68\" cy=\"65.65\" r=\"65.65\" fill=\"#e9682b\"\/>\n            <circle cx=\"392.57\" cy=\"65.65\" r=\"65.65\" fill=\"#e9652c\"\/>\n            <circle cx=\"397.47\" cy=\"65.65\" r=\"65.65\" fill=\"#e9612d\"\/>\n            <circle cx=\"402.37\" cy=\"65.65\" r=\"65.65\" fill=\"#e95e2e\"\/>\n            <circle cx=\"409.71\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5930\"\/>\n            <circle cx=\"414.6\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5631\"\/>\n            <circle cx=\"419.5\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5232\"\/>\n            <circle cx=\"424.4\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4e33\"\/>\n            <circle cx=\"428.07\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4b33\"\/>\n            <circle cx=\"432.97\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4734\"\/>\n            <circle cx=\"437.86\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4335\"\/>\n            <circle cx=\"442.76\" cy=\"65.65\" r=\"65.65\" fill=\"#ec3f36\"\/>\n            <circle cx=\"447.66\" cy=\"65.65\" r=\"65.65\" fill=\"#ed3a37\"\/>\n            <circle cx=\"452.55\" cy=\"65.65\" r=\"65.65\" fill=\"#ed3537\"\/>\n            <circle cx=\"457.45\" cy=\"65.65\" r=\"65.65\" fill=\"#ee2f38\"\/>\n            <circle cx=\"464.07\" cy=\"65.65\" r=\"65.65\" fill=\"#ee2f39\"\/>\n            <circle cx=\"472.4\" cy=\"65.65\" r=\"65.65\" fill=\"#ee353c\"\/>\n            <circle cx=\"480.74\" cy=\"65.65\" r=\"65.65\" fill=\"#ef3a3e\"\/>\n            <circle cx=\"489.08\" cy=\"65.65\" r=\"65.65\" fill=\"#ef3f40\"\/>\n            <circle cx=\"497.41\" cy=\"65.65\" r=\"65.65\" fill=\"#ef4342\"\/>\n            <circle cx=\"505.75\" cy=\"65.65\" r=\"65.65\" fill=\"#ef4744\"\/>\n            <circle cx=\"514.09\" cy=\"65.65\" r=\"65.65\" fill=\"#f04b47\"\/>\n            <circle cx=\"522.43\" cy=\"65.65\" r=\"65.65\" fill=\"#f04f49\"\/>\n            <circle cx=\"530.76\" cy=\"65.65\" r=\"65.65\" fill=\"#f0534b\"\/>\n            <circle cx=\"539.1\" cy=\"65.65\" r=\"65.65\" fill=\"#f1574e\"\/>\n            <circle cx=\"547.44\" cy=\"65.65\" r=\"65.65\" fill=\"#f15b50\"\/>\n            <circle cx=\"555.77\" cy=\"65.65\" r=\"65.65\" fill=\"#f15e53\"\/>\n            <circle cx=\"564.11\" cy=\"65.65\" r=\"65.65\" fill=\"#f16255\"\/>\n            <circle cx=\"572.45\" cy=\"65.65\" r=\"65.65\" fill=\"#f26558\"\/>\n            <circle cx=\"580.78\" cy=\"65.65\" r=\"65.65\" fill=\"#f2695a\"\/>\n            <circle cx=\"589.12\" cy=\"65.65\" r=\"65.65\" fill=\"#f26c5d\"\/>\n            <circle cx=\"462.4\" cy=\"65.65\" r=\"65.65\" fill=\"#f26b5d\"\/>\n            <circle cx=\"467.91\" cy=\"65.65\" r=\"65.65\" fill=\"#f1685d\"\/>\n            <circle cx=\"473.41\" cy=\"65.65\" r=\"65.65\" fill=\"#f0645c\"\/>\n            <circle cx=\"478.92\" cy=\"65.65\" r=\"65.65\" fill=\"#ef615c\"\/>\n            <circle cx=\"484.43\" cy=\"65.65\" r=\"65.65\" fill=\"#ef5d5c\"\/>\n            <circle cx=\"489.94\" cy=\"65.65\" r=\"65.65\" fill=\"#ee595b\"\/>\n            <circle cx=\"495.45\" cy=\"65.65\" r=\"65.65\" fill=\"#ed565b\"\/>\n            <circle cx=\"500.95\" cy=\"65.65\" r=\"65.65\" fill=\"#ed525a\"\/>\n            <circle cx=\"506.46\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4e5a\"\/>\n            <circle cx=\"511.97\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4959\"\/>\n            <circle cx=\"517.48\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4559\"\/>\n            <circle cx=\"522.99\" cy=\"65.65\" r=\"65.65\" fill=\"#ea4159\"\/>\n            <circle cx=\"528.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3c58\"\/>\n            <circle cx=\"534\" cy=\"65.65\" r=\"65.65\" fill=\"#e93758\"\/>\n            <circle cx=\"539.51\" cy=\"65.65\" r=\"65.65\" fill=\"#e83157\"\/>\n            <circle cx=\"545.02\" cy=\"65.65\" r=\"65.65\" fill=\"#e82b57\"\/>\n            <circle cx=\"550.53\" cy=\"65.65\" r=\"65.65\" fill=\"#e72456\"\/>\n            <circle cx=\"556.03\" cy=\"65.65\" r=\"65.65\" fill=\"#e71d56\"\/>\n            <circle cx=\"562.19\" cy=\"65.65\" r=\"65.65\" fill=\"#e71b57\"\/>\n            <circle cx=\"569.01\" cy=\"65.65\" r=\"65.65\" fill=\"#e72059\"\/>\n            <circle cx=\"575.84\" cy=\"65.65\" r=\"65.65\" fill=\"#e8255b\"\/>\n            <circle cx=\"582.66\" cy=\"65.65\" r=\"65.65\" fill=\"#e82a5d\"\/>\n            <circle cx=\"589.48\" cy=\"65.65\" r=\"65.65\" fill=\"#e82e5f\"\/>\n            <circle cx=\"596.3\" cy=\"65.65\" r=\"65.65\" fill=\"#e93261\"\/>\n            <circle cx=\"603.12\" cy=\"65.65\" r=\"65.65\" fill=\"#e93664\"\/>\n            <circle cx=\"609.94\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3966\"\/>\n            <circle cx=\"616.76\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3c68\"\/>\n            <circle cx=\"623.58\" cy=\"65.65\" r=\"65.65\" fill=\"#eb406a\"\/>\n            <circle cx=\"630.4\" cy=\"65.65\" r=\"65.65\" fill=\"#eb436d\"\/>\n            <circle cx=\"637.22\" cy=\"65.65\" r=\"65.65\" fill=\"#ec466f\"\/>\n            <circle cx=\"644.04\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4972\"\/>\n            <circle cx=\"650.86\" cy=\"65.65\" r=\"65.65\" fill=\"#ed4c74\"\/>\n            <circle cx=\"657.68\" cy=\"65.65\" r=\"65.65\" fill=\"#ed4e77\"\/>\n            <circle cx=\"664.5\" cy=\"65.65\" r=\"65.65\" fill=\"#ee5179\"\/>\n            <circle cx=\"671.32\" cy=\"65.65\" r=\"65.65\" fill=\"#ee547c\"\/>\n            <circle cx=\"678.14\" cy=\"65.65\" r=\"65.65\" fill=\"#ef577e\"\/>\n            <circle cx=\"684.96\" cy=\"65.65\" r=\"65.65\" fill=\"#f05981\"\/>\n            <circle cx=\"558.52\" cy=\"65.65\" r=\"65.65\" fill=\"#f05b83\"\/>\n            <circle cx=\"567.62\" cy=\"65.65\" r=\"65.65\" fill=\"#ed5781\"\/>\n            <circle cx=\"576.72\" cy=\"65.65\" r=\"65.65\" fill=\"#eb5380\"\/>\n            <circle cx=\"585.81\" cy=\"65.65\" r=\"65.65\" fill=\"#e94f7e\"\/>\n            <circle cx=\"594.91\" cy=\"65.65\" r=\"65.65\" fill=\"#e74b7d\"\/>\n            <circle cx=\"604.01\" cy=\"65.65\" r=\"65.65\" fill=\"#e5467b\"\/>\n            <circle cx=\"613.11\" cy=\"65.65\" r=\"65.65\" fill=\"#e34279\"\/>\n            <circle cx=\"622.21\" cy=\"65.65\" r=\"65.65\" fill=\"#e13d78\"\/>\n            <circle cx=\"631.31\" cy=\"65.65\" r=\"65.65\" fill=\"#e03977\"\/>\n            <circle cx=\"640.4\" cy=\"65.65\" r=\"65.65\" fill=\"#de3375\"\/>\n            <circle cx=\"649.5\" cy=\"65.65\" r=\"65.65\" fill=\"#dc2e74\"\/>\n            <circle cx=\"658.6\" cy=\"65.65\" r=\"65.65\" fill=\"#db2772\"\/>\n            <circle cx=\"667.7\" cy=\"65.65\" r=\"65.65\" fill=\"#d92171\"\/>\n            <circle cx=\"676.8\" cy=\"65.65\" r=\"65.65\" fill=\"#d71970\"\/>\n            <circle cx=\"682.15\" cy=\"65.65\" r=\"65.65\" fill=\"#d81a71\"\/>\n            <circle cx=\"686.25\" cy=\"65.65\" r=\"65.65\" fill=\"#d91e73\"\/>\n            <circle cx=\"690.35\" cy=\"65.65\" r=\"65.65\" fill=\"#da2275\"\/>\n            <circle cx=\"694.45\" cy=\"65.65\" r=\"65.65\" fill=\"#db2577\"\/>\n            <circle cx=\"698.55\" cy=\"65.65\" r=\"65.65\" fill=\"#dc2979\"\/>\n            <circle cx=\"702.65\" cy=\"65.65\" r=\"65.65\" fill=\"#dd2c7b\"\/>\n            <circle cx=\"706.75\" cy=\"65.65\" r=\"65.65\" fill=\"#df2f7d\"\/>\n            <circle cx=\"710.85\" cy=\"65.65\" r=\"65.65\" fill=\"#e03280\"\/>\n            <circle cx=\"714.95\" cy=\"65.65\" r=\"65.65\" fill=\"#e13582\"\/>\n            <circle cx=\"719.05\" cy=\"65.65\" r=\"65.65\" fill=\"#e23884\"\/>\n            <circle cx=\"723.15\" cy=\"65.65\" r=\"65.65\" fill=\"#e33b87\"\/>\n            <circle cx=\"727.25\" cy=\"65.65\" r=\"65.65\" fill=\"#e43e89\"\/>\n            <circle cx=\"731.35\" cy=\"65.65\" r=\"65.65\" fill=\"#e5408b\"\/>\n            <circle cx=\"735.45\" cy=\"65.65\" r=\"65.65\" fill=\"#e6438e\"\/>\n            <circle cx=\"739.55\" cy=\"65.65\" r=\"65.65\" fill=\"#e84690\"\/>\n            <circle cx=\"743.65\" cy=\"65.65\" r=\"65.65\" fill=\"#e94893\"\/>\n            <circle cx=\"747.75\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4b96\"\/>\n            <circle cx=\"751.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4e99\"\/>\n            <circle cx=\"757.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ef509d\"\/>\n    <\/svg>\n<\/div>\n\n        <div class=\"rqm-heading-bg\"><\/div>\n        \n\n<h2 class=\"wp-block-heading\"><strong>Standards We Navigate<\/strong><\/h2>\n\n  \n    <\/div>\n<\/div>\n\n\n<div id=\"rqm-list-block_c7ed5e9b3efff464c236b5f44ca311a6\" class=\"block-rqm-list\">\n\n    <ul class=\"rqm-list\">\n        \n<li id=\"rqm-list-item-block_1fba96243576e5e36781f732895a28ac\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">FDA 21 CFR Parts 809, 812, 814 (PMA), and 820<\/h3>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_1fba96243576e5e36781f732895a28ac\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">IVDR (EU 2017\/746), Article 2(7), 56-77, and Annex XIII and XIV<\/h3>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_1fba96243576e5e36781f732895a28ac\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">EMA GVP and Companion Diagnostic Guidelines<\/h3>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_1fba96243576e5e36781f732895a28ac\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">ISO 13485 and ISO 20916<\/h3>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_1fba96243576e5e36781f732895a28ac\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">ICH Q2(R2)\/Q14 (analytical validation for biomarker assays)<\/h3>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_1fba96243576e5e36781f732895a28ac\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">PMDA Companion Diagnostic Guidelines<\/h3>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_1fba96243576e5e36781f732895a28ac\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">EUnetHTA HTA Core Model\u00ae for CDx value dossiers<\/h3>\n\n       \n<\/li>\n\n\n    <\/ul>\n\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group alignwide is-layout-constrained wp-block-group-is-layout-constrained\" id=\"lifecyclesupport\">\n<h2 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-53a9ce56efb8d97c184eae69f728ce64\"><strong><strong><strong>Companion Diagnostic Life Cycle Support<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>Expand each to see key services.<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>.kt-accordion-id1641_b11c0f-0c .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-md, 2rem);padding-right:var(--global-kb-spacing-xl, 4rem);padding-bottom:0px;padding-left:var(--global-kb-spacing-xl, 4rem);}.kt-accordion-id1641_b11c0f-0c .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;border-top-right-radius:40px;border-bottom-right-radius:40px;border-bottom-left-radius:40px;background:#fff;font-size:30px;text-transform:none;color:#062464;padding-top:40px;padding-right:32px;padding-bottom:40px;padding-left:32px;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner, .kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner h1, .kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner h2, .kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner h3, .kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner h4, .kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner h5, .kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner h6{color:#062464;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger{background:#062464;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion--visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger, body:not(.hide-focus-outline) .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_b11c0f-0c:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#062464;}@media all and (max-width: 1024px){.kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id1641_b11c0f-0c .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:30px;padding-top:32px;padding-bottom:32px;}}@media all and (max-width: 1024px){.kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 1024px){.kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 767px){.kt-accordion-id1641_b11c0f-0c .kt-accordion-inner-wrap{display:block;}.kt-accordion-id1641_b11c0f-0c .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id1641_b11c0f-0c .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}.kt-accordion-id1641_b11c0f-0c .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:20px;padding-top:28px;padding-bottom:28px;}.kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1641_b11c0f-0c .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id1641_b11c0f-0c kt-accordion-has-7-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width:1012px\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-1 kt-pane1641_d3701d-42\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">1. Design Concept<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Biomarker-CDx alignment strategy for drug labeling&nbsp;<\/li>\n\n\n\n<li>IUO\/RUO vs. CDx classification guidance (US and EU)&nbsp;<\/li>\n\n\n\n<li>EU IVD requirements for assays used in trials (require IVD certification even if investigational)&nbsp;<\/li>\n\n\n\n<li>Companion diagnostic regulatory development roadmap&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>QMS gap analysis for diagnostic partners or labs&nbsp;<\/li>\n\n\n\n<li>GCLP-compliant planning for assay use in clinical trials&nbsp;<\/li>\n\n\n\n<li>Early quality system setup for future CDx or IUO alignment&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Biomarker and trial design strategy&nbsp;<\/li>\n\n\n\n<li>Trial schema alignment to biomarker stratification (adaptive, enrichment models)&nbsp;<\/li>\n\n\n\n<li>Clinical strategy to support therapeutic trial with investigational assay&nbsp;<\/li>\n\n\n\n<li>EU: clinical evidence planning for IVDR if CDx transition is likely&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Early payer landscape assessment&nbsp;<\/li>\n\n\n\n<li>Exploratory HEOR and diagnostic value modeling tied to drug indication&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Drafting biomarker rationale for protocols and investigator brochures&nbsp;<\/li>\n\n\n\n<li>Positioning of assay as investigational in trial documents&nbsp;<\/li>\n\n\n\n<li>EU-specific IFU (Instructions for Use) documentation for investigational IVDs&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-2 kt-pane1641_aa96ea-5d\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">2. Design &amp; Development<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>IND or IDE regulatory strategy (if assay affects trial endpoints or subject stratification)&nbsp;<\/li>\n\n\n\n<li>Companion diagnostic co-development alignment with therapeutic timeline&nbsp;<\/li>\n\n\n\n<li>Pre-submission planning with FDA or Notified Body&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Vendor qualification and audits (central labs, CROs, assay developers)&nbsp;<\/li>\n\n\n\n<li>Quality documentation support for LDT or IUO under clinical trial use&nbsp;<\/li>\n\n\n\n<li>CLIA, ISO 13485, and IVDR lab compliance review&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Protocol development including assay integration&nbsp;<\/li>\n\n\n\n<li>Site and lab qualification&nbsp;<\/li>\n\n\n\n<li>Biomarker stratification training and data capture plans&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Risk-based evidence plan for future payer support&nbsp;<\/li>\n\n\n\n<li>Clinical utility framework for companion diagnostics&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Study protocol input (biomarker sections)&nbsp;<\/li>\n\n\n\n<li>Informed consent language for assay use&nbsp;<\/li>\n\n\n\n<li>Analytical validation plans and summaries&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane1641_b0738c-02\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">3. Verification &amp; Validation<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Support for IUO documentation for IND or IDE&nbsp;<\/li>\n\n\n\n<li>Evidence generation plan aligned to FDA and IVDR expectations&nbsp;<\/li>\n\n\n\n<li>EU: confirmation of analytical performance as per IVDR Annex I&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Design control documentation&nbsp;<\/li>\n\n\n\n<li>Verification protocol support (analytical precision, accuracy, specificity)&nbsp;<\/li>\n\n\n\n<li>Documentation to support regulatory submission or trial audit readiness&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Coordination of validation data with clinical endpoints&nbsp;<\/li>\n\n\n\n<li>Analysis of biomarker-stratified outcomes&nbsp;<\/li>\n\n\n\n<li>EU: Clinical performance data planning for IVD certification&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Incorporating real-world elements into validation design (where applicable)&nbsp;<\/li>\n\n\n\n<li>Evidence mapping to potential HTA requirements&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Drafting validation reports (analytical and clinical)&nbsp;<\/li>\n\n\n\n<li>Cross-linking assay performance to therapeutic claims&nbsp;<\/li>\n\n\n\n<li>Preparing content for regulatory submission or scientific publication&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane1641_3c76db-64\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">4. Clinical Evidence Generation<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Regulatory support for clinical protocols and endpoints tied to biomarker use&nbsp;<\/li>\n\n\n\n<li>EU: Ensuring IVD certificate or performance study application is in place&nbsp;<\/li>\n\n\n\n<li>FDA meeting prep (Type C, Pre-Sub) for assay data&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Oversight of assay use and data integrity during trials&nbsp;<\/li>\n\n\n\n<li>Data traceability support for biomarker performance&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Trial execution support with embedded assay use&nbsp;<\/li>\n\n\n\n<li>Risk-based monitoring of assay-related endpoints&nbsp;<\/li>\n\n\n\n<li>Multi-arm and enrichment trial design consulting&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Capture of clinical utility evidence&nbsp;<\/li>\n\n\n\n<li>Drafting of payer-facing clinical summaries post-trial&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Interim and final CSR sections related to biomarker and assay&nbsp;<\/li>\n\n\n\n<li>Clinical evaluation reports for EU if conversion to CDx occurs&nbsp;<\/li>\n\n\n\n<li>Regulatory briefing documentation&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>.kt-accordion-id1641_4e04ff-59 .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-md, 2rem);padding-right:var(--global-kb-spacing-xl, 4rem);padding-bottom:0px;padding-left:var(--global-kb-spacing-xl, 4rem);}.kt-accordion-id1641_4e04ff-59 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;border-top-right-radius:40px;border-bottom-right-radius:40px;border-bottom-left-radius:40px;background:#fff;font-size:30px;text-transform:none;color:#062464;padding-top:40px;padding-right:32px;padding-bottom:40px;padding-left:32px;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner, .kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner h1, .kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner h2, .kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner h3, .kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner h4, .kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner h5, .kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner h6{color:#062464;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger{background:#062464;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion--visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger, body:not(.hide-focus-outline) .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id1641_4e04ff-59:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#062464;}@media all and (max-width: 1024px){.kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id1641_4e04ff-59 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:30px;padding-top:32px;padding-bottom:32px;}}@media all and (max-width: 1024px){.kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 1024px){.kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 767px){.kt-accordion-id1641_4e04ff-59 .kt-accordion-inner-wrap{display:block;}.kt-accordion-id1641_4e04ff-59 .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id1641_4e04ff-59 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}.kt-accordion-id1641_4e04ff-59 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:20px;padding-top:28px;padding-bottom:28px;}.kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1641_4e04ff-59 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id1641_4e04ff-59 kt-accordion-has-6-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width:1012px\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-3 kt-pane1641_682a95-df\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">5. Regulatory Submissions<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Companion diagnostic module preparation for NDA\/BLA\/MAA&nbsp;<\/li>\n\n\n\n<li>Standalone CDx PMA\/510(k) submission support&nbsp;<\/li>\n\n\n\n<li>EU: Performance evaluation reports, GSPR, Technical Documentation per IVDR&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Final design history file and DHF compilation&nbsp;<\/li>\n\n\n\n<li>Risk management file preparation&nbsp;<\/li>\n\n\n\n<li>Traceability matrix linking assay to therapeutic use&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Final trial evidence summaries&nbsp;<\/li>\n\n\n\n<li>Preparation for clinical site inspection or audits&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Dossier development for EU payers and US CMS engagement&nbsp;<\/li>\n\n\n\n<li>Mapping evidence to coding\/reimbursement pathways&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Submission-ready labeling, IFU, and summary of safety and performance&nbsp;<\/li>\n\n\n\n<li>PMA\/510(k) narrative components&nbsp;<\/li>\n\n\n\n<li>EMA or NB response packages&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-4 kt-pane1641_5fd4e6-07\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">6. Market Access &amp; Launch<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Post-approval change support&nbsp;<\/li>\n\n\n\n<li>Labeling alignment with drug&nbsp;<\/li>\n\n\n\n<li>EU: Notified Body communication and updates&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Supplier and lab network quality agreements&nbsp;<\/li>\n\n\n\n<li>CAPA, complaint handling, and postmarket change management&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Postmarket performance studies (if required)&nbsp;<\/li>\n\n\n\n<li>Evidence generation for new indications&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Payer engagement and evidence updates&nbsp;<\/li>\n\n\n\n<li>Coding pathway activation (PLA, Z-code)&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Clinical utility publications&nbsp;<\/li>\n\n\n\n<li>Label updates&nbsp;<\/li>\n\n\n\n<li>HTA submission writing&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane1641_d3f996-f1\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">7. Post-Market Activities<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Vigilance reporting (MDR)&nbsp;<\/li>\n\n\n\n<li>Labeling change support&nbsp;<\/li>\n\n\n\n<li>PMCF\/PMPF plan development&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Ongoing QMS support&nbsp;<\/li>\n\n\n\n<li>Supplier audits&nbsp;<\/li>\n\n\n\n<li>Complaint trending analysis&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>PMCF study oversight&nbsp;<\/li>\n\n\n\n<li>Registry participation and data integration&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Evidence refresh to maintain coverage&nbsp;<\/li>\n\n\n\n<li>Price renegotiation strategy&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>PMCF reports&nbsp;<\/li>\n\n\n\n<li>Labeling changes&nbsp;<\/li>\n\n\n\n<li>Scientific publications for long-term data&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane1641_adb61e-21\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">8. Emergency Support<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Response strategy for FDA\/EMA\/Notified Body&nbsp;<\/li>\n\n\n\n<li>CAPA documentation&nbsp;<\/li>\n\n\n\n<li>Reclassification strategy&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Rapid QMS remediation&nbsp;<\/li>\n\n\n\n<li>SOP gap analysis and rewrite&nbsp;<\/li>\n\n\n\n<li>Field action documentation&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Root cause analysis of trial deviation or failure&nbsp;<\/li>\n\n\n\n<li>Emergency study redesign&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Damage control with payers&nbsp;<\/li>\n\n\n\n<li>Evidence remediation planning&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Crisis response documentation&nbsp;<\/li>\n\n\n\n<li>Justification memos&nbsp;<\/li>\n\n\n\n<li>Incident reports<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<div id=\"rqm-group-block_1c7b2f40cb481370de1b36832b2ea3fb\" class=\"block-rqm-group alignfull\" style=\"background-image: url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-right.avif'), url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-left.avif');background-position: right bottom -30em, left top -30em;\">\n\n    <div class=\"rqm-group-content\">\n        \n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px\">\n<h2 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-5628178f1f3ff7b9ff80bb98d536f913\"><strong>Flexible Partnering Solutions<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full has-custom-border\"><a href=\"\/contact\/\"><img decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing.jpg\" alt=\"Full-Service Outsourcing\" class=\"wp-image-1301\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing.jpg 800w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing-768x512.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Outsourcing<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Customizable and scalable outsourcing scoped for entire projects, specific functions, or defined parts of a function. Leverage RQM+ expertise and flexibility while your teams stay focused on core competencies, corporate goals, and innovation. <a href=\"https:\/\/www.rqmplus.com\/contact\/\">Partner with us.<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large has-custom-border\"><a href=\"\/contact\/\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1024x683.jpg\" alt=\"Professional Consulting\" class=\"wp-image-976\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1024x683.jpg 1024w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-768x512.jpg 768w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1536x1024.jpg 1536w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper.jpg 1800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Consulting<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Targeted, outcome-focused expertise to solve defined MedTech challenges. RQM+<br>consultants step in with practical, actionable guidance and hands-on execution to drive timely resolution. <a href=\"https:\/\/www.rqmplus.com\/contact\/\">Partner with us.<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large has-custom-border\"><a href=\"\/match-with-a-contractor\/\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1024x683.jpg\" alt=\"Professional Staffing\" class=\"wp-image-1223\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1024x683.jpg 1024w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-768x512.jpg 768w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1536x1024.jpg 1536w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611.jpg 1800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Staff Augmentation<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Fill skill or capacity gaps with MedTech talent from RQM+. We provide on-demand<br>professionals, functional service support, fast deployment for tight timelines, and<br>contract-to-hire options that integrate seamlessly with your team. <a href=\"https:\/\/www.rqmplus.com\/match-with-a-contractor\/\">Match with a contractor.<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>RQM+ delivers integrated and tailored regulatory, clinical, and market access support for pharmaceutical sponsors, biotech companies, and diagnostic developers advancing&#8230;<\/p>\n","protected":false},"author":7,"featured_media":1649,"parent":38,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-1641","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"card_info":{"title":"Companion Diagnostics (CDx)","link":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/","link_target":"_self","name":"Page","slug":"page","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp","excerpt":"RQM+ delivers integrated and tailored regulatory, clinical, and market access support for pharmaceutical sponsors, biotech companies, and diagnostic developers advancing...","display_date":"May 21, 2025"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Companion Diagnostics Solutions | CDx Expertise | RQM+<\/title>\n<meta name=\"description\" content=\"RQM+ aids in finding a companion diagnostics solution. Get expert regulatory strategy for companion diagnostics and CDx development.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Companion Diagnostics Solutions | CDx Expertise | RQM+\" \/>\n<meta property=\"og:description\" content=\"RQM+ aids in finding a companion diagnostics solution. Get expert regulatory strategy for companion diagnostics and CDx development.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/\" \/>\n<meta property=\"og:site_name\" content=\"RQM+\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RQMplus\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-19T18:26:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"2048\" \/>\n\t<meta property=\"og:image:height\" content=\"1366\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@RQMplus\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/\",\"url\":\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/\",\"name\":\"Companion Diagnostics Solutions | CDx Expertise | RQM+\",\"isPartOf\":{\"@id\":\"https:\/\/www.rqmplus.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp\",\"datePublished\":\"2025-05-21T20:44:06+00:00\",\"dateModified\":\"2025-09-19T18:26:52+00:00\",\"description\":\"RQM+ aids in finding a companion diagnostics solution. Get expert regulatory strategy for companion diagnostics and CDx development.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#primaryimage\",\"url\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp\",\"contentUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp\",\"width\":2048,\"height\":1366},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Expertise\",\"item\":\"https:\/\/www.rqmplus.com\/expertise\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Companion Diagnostics (CDx)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.rqmplus.com\/#website\",\"url\":\"https:\/\/www.rqmplus.com\/\",\"name\":\"RQM+\",\"description\":\"Evolving MedTech\",\"publisher\":{\"@id\":\"https:\/\/www.rqmplus.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.rqmplus.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.rqmplus.com\/#organization\",\"name\":\"RQM+\",\"url\":\"https:\/\/www.rqmplus.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png\",\"contentUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png\",\"width\":696,\"height\":696,\"caption\":\"RQM+\"},\"image\":{\"@id\":\"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/RQMplus\",\"https:\/\/x.com\/RQMplus\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Companion Diagnostics Solutions | CDx Expertise | RQM+","description":"RQM+ aids in finding a companion diagnostics solution. Get expert regulatory strategy for companion diagnostics and CDx development.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/","og_locale":"en_US","og_type":"article","og_title":"Companion Diagnostics Solutions | CDx Expertise | RQM+","og_description":"RQM+ aids in finding a companion diagnostics solution. Get expert regulatory strategy for companion diagnostics and CDx development.","og_url":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/","og_site_name":"RQM+","article_publisher":"https:\/\/www.facebook.com\/RQMplus","article_modified_time":"2025-09-19T18:26:52+00:00","og_image":[{"width":2048,"height":1366,"url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_site":"@RQMplus","twitter_misc":{"Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/","url":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/","name":"Companion Diagnostics Solutions | CDx Expertise | RQM+","isPartOf":{"@id":"https:\/\/www.rqmplus.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#primaryimage"},"image":{"@id":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#primaryimage"},"thumbnailUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp","datePublished":"2025-05-21T20:44:06+00:00","dateModified":"2025-09-19T18:26:52+00:00","description":"RQM+ aids in finding a companion diagnostics solution. Get expert regulatory strategy for companion diagnostics and CDx development.","breadcrumb":{"@id":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#primaryimage","url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp","contentUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/female-engineer-focused-on-equipment-in-a-modern-lab-showcasing-technology-and-expertise.-3862638-2048x1366-1.webp","width":2048,"height":1366},{"@type":"BreadcrumbList","@id":"https:\/\/www.rqmplus.com\/expertise\/companion-diagnostics-cdx\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Expertise","item":"https:\/\/www.rqmplus.com\/expertise\/"},{"@type":"ListItem","position":2,"name":"Companion Diagnostics (CDx)"}]},{"@type":"WebSite","@id":"https:\/\/www.rqmplus.com\/#website","url":"https:\/\/www.rqmplus.com\/","name":"RQM+","description":"Evolving MedTech","publisher":{"@id":"https:\/\/www.rqmplus.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rqmplus.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.rqmplus.com\/#organization","name":"RQM+","url":"https:\/\/www.rqmplus.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png","contentUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png","width":696,"height":696,"caption":"RQM+"},"image":{"@id":"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RQMplus","https:\/\/x.com\/RQMplus"]}]}},"_links":{"self":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/pages\/1641","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/comments?post=1641"}],"version-history":[{"count":0,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/pages\/1641\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/pages\/38"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/media\/1649"}],"wp:attachment":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/media?parent=1641"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}