Guardant360 CDx
A blood test that reads a tumour's mutations without a tissue biopsy and is the FDA-approved gateway to several targeted drugs.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| 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 |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- 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.
Latest papers
topQuery for this drug: (TITLE:"Guardant360 CDx" OR ABSTRACT:"Guardant360 CDx") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Guardant360 CDx, not a curated reading list.
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