{"entity":{"id":"foundationone-cdx","kind":"drug","name":"FoundationOne CDx / Liquid CDx","aka":[],"tldr":"The FDA-approved tissue (324 genes) and blood genomic tests that serve as companion diagnostics for dozens of drugs.","summary":"FoundationOne CDx is Foundation Medicine's (Roche) tissue-based comprehensive genomic profiling test, using hybrid-capture next-generation sequencing of 324 genes to report mutations, copy-number changes, fusions, tumour mutational burden, microsatellite instability and homologous recombination deficiency by loss of heterozygosity; FoundationOne Liquid CDx applies the approach to circulating tumour DNA in blood. The tissue test was FDA-approved in 2017 and the liquid test in 2020. They are companion diagnostics for more than 30 therapies, including olaparib, capivasertib, trastuzumab deruxtecan for HER2-mutant NSCLC and selpercatinib, so one report can open several treatment doors at once. Tissue-blood concordance and unequal access remain issues. For a newcomer: a single sequencing test that tells an oncologist which targeted drugs a tumour might respond to.","status":"approved","asOf":"2026-09-04","links":[{"label":"FDA premarket approval P170019: FoundationOne CDx","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170019"},{"label":"Foundation Medicine: FoundationOne CDx","url":"https://www.foundationmedicine.com/test/foundationone-cdx"}],"tags":[],"related":["tmb-testing"],"cancers":["tnbc","pancreatic","colorectal"],"sections":[],"technologies":["cgp","companion-diagnostic","liquid-biopsy"],"targets":[],"drugs":[],"companies":["foundation-medicine"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-radovich-ctdna-ctc-bre12-158-jama-oncol-2020","paper-barroso-sousa-breast-tmb-prevalence-ann-oncol-2020","paper-singhi-targeted-genome-profiling-3594-pdac-gastroenterology-2019","paper-pishvaian-lancet-oncol","paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017"],"journals":[],"dependsOn":[],"notes":["Pancreatic ductal adenocarcinoma: the 3,594-tumour profiling series that fixed the 88% KRAS rate, the 14% repair-gene rate and the 0.5% MSI or TMB-high rate was run on this panel (Singhi 2019); comprehensive profiling found actionable alterations in 26% of 1,082 Know Your Tumor patients (Pishvaian 2020).","Colorectal cancer: a comprehensive panel covers extended RAS, BRAF, MSI, tumour mutational burden and HER2 amplification in one test, which is what the guideline asks for, but panel content decides what is seen: RSPO2, ACVR2A and BCL9L are absent from several widely used panels, and fusion detection depends on intron baiting or RNA (Sepulveda 2017)."],"modality":"Comprehensive genomic profiling test","mechanism":"Hybrid-capture NGS of 324 genes.","approvals":[{"region":"US","year":2017,"indication":"Tissue CGP companion diagnostic (Liquid CDx 2020)"},{"region":"EU","year":2019,"indication":"CE-IVD"}],"mechanismSteps":["FFPE tumour DNA is extracted","Hybrid-capture enrichment of 324 genes","Deep sequencing detects mutations, copy-number changes, fusions, TMB, MSI","Variants are matched to FDA-approved therapies and trials in a report"],"toxicity":[],"access":[{"country":"US","listPrice":"~$3,500 (Medicare CLFS rate for FoundationOne CDx)","reimbursement":"Medicare national coverage for FDA-approved CGP in advanced cancer (NCD 90.2); commercial coverage broad","source":"https://www.foundationmedicine.com","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2017-11-30","type":"approval","region":"US","note":"FDA approval and parallel Medicare NCD: first FDA-approved broad CGP companion diagnostic","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-08-26","type":"approval","region":"US","note":"FoundationOne Liquid CDx approved","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-06","type":"label-change","region":"US","note":"TMB ≥10 mut/Mb companion claim for pembrolizumab","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/foundationone-cdx/","neighbours":{"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":"hrd-genomic-scar-scores","kind":"technology","name":"HRD genomic scar scores (GIS, LOH, HRDetect)","route":"/technologies/hrd-genomic-scar-scores/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"msi-mmr-testing","kind":"technology","name":"MSI and mismatch-repair testing","route":"/technologies/msi-mmr-testing/"},{"id":"tmb-testing","kind":"technology","name":"Tumour mutational burden testing","route":"/technologies/tmb-testing/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"company":[{"id":"foundation-medicine","kind":"company","name":"Foundation Medicine (Roche)","route":"/companies/foundation-medicine/"}],"paper":[{"id":"paper-radovich-ctdna-ctc-bre12-158-jama-oncol-2020","kind":"paper","name":"Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical Trial","route":"/key-papers/paper-radovich-ctdna-ctc-bre12-158-jama-oncol-2020/"},{"id":"paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017","kind":"paper","name":"Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO","route":"/key-papers/paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017/"},{"id":"paper-pishvaian-lancet-oncol","kind":"paper","name":"Overall survival in patients with pancreatic cancer receiving matched therapies following molecular profiling: a retrospective analysis of the Know Your Tumor registry trial","route":"/key-papers/paper-pishvaian-lancet-oncol/"},{"id":"paper-barroso-sousa-breast-tmb-prevalence-ann-oncol-2020","kind":"paper","name":"Prevalence and mutational determinants of high tumor mutation burden in breast cancer","route":"/key-papers/paper-barroso-sousa-breast-tmb-prevalence-ann-oncol-2020/"},{"id":"paper-singhi-targeted-genome-profiling-3594-pdac-gastroenterology-2019","kind":"paper","name":"Real-time targeted genome profile analysis of pancreatic ductal adenocarcinomas identifies genetic alterations that might be targeted with existing drugs or used as biomarkers","route":"/key-papers/paper-singhi-targeted-genome-profiling-3594-pdac-gastroenterology-2019/"}],"term":[{"id":"genomic-profiling","kind":"term","name":"Genomic profiling","route":"/terms/genomic-profiling/"},{"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/"}],"person":[{"id":"michael-berger","kind":"person","name":"Michael F. Berger","route":"/people/michael-berger/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"}],"idea":[{"id":"idea-acc-reflex-genomic-profiling-at-diagnosis","kind":"idea","name":"Pathologists order genomic profiling automatically at diagnosis of advanced cancer","route":"/ideas/idea-acc-reflex-genomic-profiling-at-diagnosis/"},{"id":"idea-tr2-cdx-mutual-recognition","kind":"idea","name":"Regulators recognise each other's companion diagnostic approvals","route":"/ideas/idea-tr2-cdx-mutual-recognition/"}],"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/"}],"drug":[{"id":"guardant360-cdx","kind":"drug","name":"Guardant360 CDx","route":"/drugs/guardant360-cdx/"}],"biomarker":[{"id":"akt1-e17k","kind":"biomarker","name":"AKT1 E17K mutation","route":"/biomarkers/akt1-e17k/"},{"id":"alk-fusion","kind":"biomarker","name":"ALK fusion (ALK-positive)","route":"/biomarkers/alk-fusion/"},{"id":"braf-fusion","kind":"biomarker","name":"BRAF fusion or rearrangement","route":"/biomarkers/braf-fusion/"},{"id":"egfr-exon-19-deletion","kind":"biomarker","name":"EGFR exon 19 deletion","route":"/biomarkers/egfr-exon-19-deletion/"},{"id":"fgfr2-fusion-rearrangement","kind":"biomarker","name":"FGFR2 fusion or rearrangement","route":"/biomarkers/fgfr2-fusion-rearrangement/"},{"id":"met-ex14","kind":"biomarker","name":"MET exon 14 skipping mutation","route":"/biomarkers/met-ex14/"},{"id":"msi-high","kind":"biomarker","name":"MSI-high (microsatellite instability by PCR or sequencing)","route":"/biomarkers/msi-high/"},{"id":"ntrk-fusion","kind":"biomarker","name":"NTRK1/2/3 gene fusion","route":"/biomarkers/ntrk-fusion/"},{"id":"pik3ca-hotspot-mutation","kind":"biomarker","name":"PIK3CA mutation","route":"/biomarkers/pik3ca-hotspot-mutation/"},{"id":"pten-alteration","kind":"biomarker","name":"PTEN alteration (sequencing) and PTEN loss (IHC)","route":"/biomarkers/pten-alteration/"},{"id":"ras-wild-type","kind":"biomarker","name":"RAS wild-type (extended KRAS and NRAS testing)","route":"/biomarkers/ras-wild-type/"},{"id":"ret-fusion","kind":"biomarker","name":"RET fusion and RET mutation","route":"/biomarkers/ret-fusion/"},{"id":"ros1-fusion","kind":"biomarker","name":"ROS1 fusion (ROS1-positive)","route":"/biomarkers/ros1-fusion/"},{"id":"tmb-high","kind":"biomarker","name":"TMB-high (tumour mutational burden >= 10 mutations per megabase)","route":"/biomarkers/tmb-high/"},{"id":"brca-somatic","kind":"biomarker","name":"Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations","route":"/biomarkers/brca-somatic/"}]}}