# FoundationOne CDx / Liquid CDx

Source: https://onco.cc/drugs/foundationone-cdx/  
OnCo record `foundationone-cdx` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Modality: Comprehensive genomic profiling test
- Mechanism: Hybrid-capture NGS of 324 genes.
- Approvals: US 2017: Tissue CGP companion diagnostic (Liquid CDx 2020); EU 2019: CE-IVD

## 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).

## Sources

- FDA premarket approval P170019: FoundationOne CDx: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170019
- Foundation Medicine: FoundationOne CDx: https://www.foundationmedicine.com/test/foundationone-cdx

## Connected records

- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Comprehensive genomic profiling](https://onco.cc/technologies/cgp/), [HRD genomic scar scores (GIS, LOH, HRDetect)](https://onco.cc/technologies/hrd-genomic-scar-scores/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [MSI and mismatch-repair testing](https://onco.cc/technologies/msi-mmr-testing/), [Tumour mutational burden testing](https://onco.cc/technologies/tmb-testing/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- companies: [Foundation Medicine (Roche)](https://onco.cc/companies/foundation-medicine/)
- key papers: [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](https://onco.cc/key-papers/paper-radovich-ctdna-ctc-bre12-158-jama-oncol-2020/), [Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO](https://onco.cc/key-papers/paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017/), [Overall survival in patients with pancreatic cancer receiving matched therapies following molecular profiling: a retrospective analysis of the Know Your Tumor registry trial](https://onco.cc/key-papers/paper-pishvaian-lancet-oncol/), [Prevalence and mutational determinants of high tumor mutation burden in breast cancer](https://onco.cc/key-papers/paper-barroso-sousa-breast-tmb-prevalence-ann-oncol-2020/), [Real-time targeted genome profile analysis of pancreatic ductal adenocarcinomas identifies genetic alterations that might be targeted with existing drugs or used as biomarkers](https://onco.cc/key-papers/paper-singhi-targeted-genome-profiling-3594-pdac-gastroenterology-2019/)
- terms: [Genomic profiling](https://onco.cc/terms/genomic-profiling/), [HER2 testing in biliary tract cancer (IHC, ISH and NGS)](https://onco.cc/terms/her2-testing-in-biliary-cancer/)
- people: [Michael F. Berger](https://onco.cc/people/michael-berger/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/)
- ideas: [Pathologists order genomic profiling automatically at diagnosis of advanced cancer](https://onco.cc/ideas/idea-acc-reflex-genomic-profiling-at-diagnosis/), [Regulators recognise each other's companion diagnostic approvals](https://onco.cc/ideas/idea-tr2-cdx-mutual-recognition/)
- roadmaps: [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)
- drugs: [Guardant360 CDx](https://onco.cc/drugs/guardant360-cdx/)
- biomarkers: [AKT1 E17K mutation](https://onco.cc/biomarkers/akt1-e17k/), [ALK fusion (ALK-positive)](https://onco.cc/biomarkers/alk-fusion/), [BRAF fusion or rearrangement](https://onco.cc/biomarkers/braf-fusion/), [EGFR exon 19 deletion](https://onco.cc/biomarkers/egfr-exon-19-deletion/), [FGFR2 fusion or rearrangement](https://onco.cc/biomarkers/fgfr2-fusion-rearrangement/), [MET exon 14 skipping mutation](https://onco.cc/biomarkers/met-ex14/), [MSI-high (microsatellite instability by PCR or sequencing)](https://onco.cc/biomarkers/msi-high/), [NTRK1/2/3 gene fusion](https://onco.cc/biomarkers/ntrk-fusion/), [PIK3CA mutation](https://onco.cc/biomarkers/pik3ca-hotspot-mutation/), [PTEN alteration (sequencing) and PTEN loss (IHC)](https://onco.cc/biomarkers/pten-alteration/), [RAS wild-type (extended KRAS and NRAS testing)](https://onco.cc/biomarkers/ras-wild-type/), [RET fusion and RET mutation](https://onco.cc/biomarkers/ret-fusion/), [ROS1 fusion (ROS1-positive)](https://onco.cc/biomarkers/ros1-fusion/), [TMB-high (tumour mutational burden >= 10 mutations per megabase)](https://onco.cc/biomarkers/tmb-high/), [Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations](https://onco.cc/biomarkers/brca-somatic/)

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