# Guardant360 CDx

Source: https://onco.cc/drugs/guardant360-cdx/  
OnCo record `guardant360-cdx` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- 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: US 2020: Companion diagnostic for osimertinib (EGFR) in NSCLC; first liquid comprehensive genomic profiling test; US 2021: Companion claims for sotorasib (KRAS G12C) and amivantamab (EGFR exon 20 insertion); US 2023: Companion diagnostic for elacestrant (ESR1 mutation) in ER+/HER2- advanced breast cancer

## 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.

## Sources

- FDA PMA P200010: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200010

## Connected records

- drugs: [Amivantamab](https://onco.cc/drugs/amivantamab/), [cobas EGFR Mutation Test v2](https://onco.cc/drugs/cobas-egfr-mutation-test/), [Elacestrant](https://onco.cc/drugs/elacestrant/), [FoundationOne CDx / Liquid CDx](https://onco.cc/drugs/foundationone-cdx/), [Osimertinib](https://onco.cc/drugs/osimertinib/), [Sotorasib](https://onco.cc/drugs/sotorasib/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Comprehensive genomic profiling](https://onco.cc/technologies/cgp/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/)
- targets: [ALK](https://onco.cc/targets/alk/), [BRAF](https://onco.cc/targets/braf/), [EGFR](https://onco.cc/targets/egfr/), [Estrogen receptor (ERα)](https://onco.cc/targets/estrogen-receptor/), [KRAS](https://onco.cc/targets/kras/), [MET](https://onco.cc/targets/met/), [RET](https://onco.cc/targets/ret/)
- companies: [Guardant Health](https://onco.cc/companies/guardant-health/)
- terms: [Circulating tumour DNA (ctDNA)](https://onco.cc/terms/ctdna/), [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [ESR1 mutation](https://onco.cc/terms/esr1-mutation/), [HER2 testing in biliary tract cancer (IHC, ISH and NGS)](https://onco.cc/terms/her2-testing-in-biliary-cancer/)
- key papers: [ALK resistance mutations and efficacy of lorlatinib in advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer](https://onco.cc/key-papers/paper-shaw-alk-resistance-mutations-lorlatinib-jco-2019/), [Assessment of resistance mechanisms and clinical implications in patients with EGFR T790M-positive lung cancer and acquired resistance to osimertinib](https://onco.cc/key-papers/paper-oxnard-osimertinib-resistance-mechanisms-jama-oncol-2018/), [Circulating tumor DNA profiling of advanced biliary tract cancers](https://onco.cc/key-papers/paper-mody-biliary-ctdna-profiling-jco-po-2019/), [Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial (TRIUMPH)](https://onco.cc/key-papers/paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021/), [NILE: clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer](https://onco.cc/key-papers/paper-leighl-nile-cfdna-tissue-genotyping-ccr-2019/), [The molecular evolution of acquired resistance to targeted EGFR blockade in colorectal cancers](https://onco.cc/key-papers/paper-diaz-molecular-evolution-egfr-resistance-colorectal-nature-2012/)
- 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/)
- biomarkers: [EGFR exon 19 deletion](https://onco.cc/biomarkers/egfr-exon-19-deletion/), [EGFR exon 20 insertion](https://onco.cc/biomarkers/egfr-exon-20-insertion/), [ESR1 mutation (ligand-binding domain, usually in ctDNA)](https://onco.cc/biomarkers/esr1-mutation-ctdna/), [HER2 (ERBB2) activating mutation](https://onco.cc/biomarkers/her2-mutation/), [KRAS G12C](https://onco.cc/biomarkers/kras-g12c/)

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