{"entity":{"id":"guardant360-cdx","kind":"drug","name":"Guardant360 CDx","aka":[],"tldr":"A blood test that reads a tumour's mutations without a tissue biopsy and is the FDA-approved gateway to several targeted drugs.","summary":"Guardant360 CDx was the first blood-based comprehensive genomic profiling test approved by the FDA (7 August 2020, PMA P200010), initially as a companion diagnostic for osimertinib in EGFR-mutant non-small-cell lung cancer. Companion claims were added for sotorasib (KRAS G12C, 2021), amivantamab (EGFR exon 20 insertions, 2021) and elacestrant (ESR1 mutations in ER-positive breast cancer, 2023). A negative blood result does not exclude an alteration, because some tumours shed little DNA; labels direct reflex tissue testing when plasma is negative. Guardant360 also reports tumour profiling results beyond the companion claims as professional information.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA PMA P200010","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200010"}],"tags":["test"],"related":["foundationone-cdx","cobas-egfr-mutation-test"],"cancers":["nsclc","breast-hr-positive","pancreatic","colorectal"],"sections":[],"technologies":["liquid-biopsy","companion-diagnostic","cgp"],"targets":["egfr","kras","estrogen-receptor","met","alk","ret","braf"],"drugs":["osimertinib","sotorasib","amivantamab","elacestrant"],"companies":["guardant-health"],"institutions":[],"pathways":[],"terms":["ctdna","companion-diagnostic-term","esr1-mutation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-diaz-molecular-evolution-egfr-resistance-colorectal-nature-2012","paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021"],"journals":[],"dependsOn":[],"notes":["What a result means: a detected alteration with a companion claim makes you eligible for the matched drug; a negative blood test should be followed by tissue testing before ruling a target out.","Pancreatic ductal adenocarcinoma: plasma panels detect KRAS in about half of advanced patients, with detection and allele fraction both prognostic, but a negative result does not exclude disease and no pancreatic label uses a plasma threshold (Pietrasz 2017, Bernard 2019).","Colorectal cancer: plasma panels genotype RAS and BRAF when tissue is exhausted, track the RAS-mutant clones that cause acquired resistance to EGFR antibodies months before imaging (Diaz 2012), and can select HER2-amplified patients for treatment as accurately as tissue when tumour fraction is adequate (Nakamura 2021). A negative plasma result in low-volume disease does not exclude an alteration."],"brand":"Guardant360 CDx","modality":"Liquid biopsy companion diagnostic test (NGS, cfDNA)","mechanism":"Hybrid-capture next-generation sequencing of cell-free DNA from a blood draw, reporting mutations, amplifications and fusions across more than 50 genes with companion-diagnostic claims for specific drugs.","approvals":[{"region":"US","year":2020,"indication":"Companion diagnostic for osimertinib (EGFR) in NSCLC; first liquid comprehensive genomic profiling test"},{"region":"US","year":2021,"indication":"Companion claims for sotorasib (KRAS G12C) and amivantamab (EGFR exon 20 insertion)"},{"region":"US","year":2023,"indication":"Companion diagnostic for elacestrant (ESR1 mutation) in ER+/HER2- advanced breast cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/guardant360-cdx/","neighbours":{"drug":[{"id":"amivantamab","kind":"drug","name":"Amivantamab","route":"/drugs/amivantamab/"},{"id":"cobas-egfr-mutation-test","kind":"drug","name":"cobas EGFR Mutation Test v2","route":"/drugs/cobas-egfr-mutation-test/"},{"id":"elacestrant","kind":"drug","name":"Elacestrant","route":"/drugs/elacestrant/"},{"id":"foundationone-cdx","kind":"drug","name":"FoundationOne CDx / Liquid CDx","route":"/drugs/foundationone-cdx/"},{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"},{"id":"sotorasib","kind":"drug","name":"Sotorasib","route":"/drugs/sotorasib/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"},{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"},{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"estrogen-receptor","kind":"target","name":"Estrogen receptor (ERα)","route":"/targets/estrogen-receptor/"},{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"},{"id":"met","kind":"target","name":"MET","route":"/targets/met/"},{"id":"ret","kind":"target","name":"RET","route":"/targets/ret/"}],"company":[{"id":"guardant-health","kind":"company","name":"Guardant Health","route":"/companies/guardant-health/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"esr1-mutation","kind":"term","name":"ESR1 mutation","route":"/terms/esr1-mutation/"},{"id":"her2-testing-in-biliary-cancer","kind":"term","name":"HER2 testing in biliary tract cancer (IHC, ISH and NGS)","route":"/terms/her2-testing-in-biliary-cancer/"}],"paper":[{"id":"paper-shaw-alk-resistance-mutations-lorlatinib-jco-2019","kind":"paper","name":"ALK resistance mutations and efficacy of lorlatinib in advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer","route":"/key-papers/paper-shaw-alk-resistance-mutations-lorlatinib-jco-2019/"},{"id":"paper-oxnard-osimertinib-resistance-mechanisms-jama-oncol-2018","kind":"paper","name":"Assessment of resistance mechanisms and clinical implications in patients with EGFR T790M-positive lung cancer and acquired resistance to osimertinib","route":"/key-papers/paper-oxnard-osimertinib-resistance-mechanisms-jama-oncol-2018/"},{"id":"paper-mody-biliary-ctdna-profiling-jco-po-2019","kind":"paper","name":"Circulating tumor DNA profiling of advanced biliary tract cancers","route":"/key-papers/paper-mody-biliary-ctdna-profiling-jco-po-2019/"},{"id":"paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021","kind":"paper","name":"Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial (TRIUMPH)","route":"/key-papers/paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021/"},{"id":"paper-leighl-nile-cfdna-tissue-genotyping-ccr-2019","kind":"paper","name":"NILE: clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer","route":"/key-papers/paper-leighl-nile-cfdna-tissue-genotyping-ccr-2019/"},{"id":"paper-diaz-molecular-evolution-egfr-resistance-colorectal-nature-2012","kind":"paper","name":"The molecular evolution of acquired resistance to targeted EGFR blockade in colorectal cancers","route":"/key-papers/paper-diaz-molecular-evolution-egfr-resistance-colorectal-nature-2012/"}],"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}],"biomarker":[{"id":"egfr-exon-19-deletion","kind":"biomarker","name":"EGFR exon 19 deletion","route":"/biomarkers/egfr-exon-19-deletion/"},{"id":"egfr-exon-20-insertion","kind":"biomarker","name":"EGFR exon 20 insertion","route":"/biomarkers/egfr-exon-20-insertion/"},{"id":"esr1-mutation-ctdna","kind":"biomarker","name":"ESR1 mutation (ligand-binding domain, usually in ctDNA)","route":"/biomarkers/esr1-mutation-ctdna/"},{"id":"her2-mutation","kind":"biomarker","name":"HER2 (ERBB2) activating mutation","route":"/biomarkers/her2-mutation/"},{"id":"kras-g12c","kind":"biomarker","name":"KRAS G12C","route":"/biomarkers/kras-g12c/"}]}}