Multiple liquid companion diagnostic (CDx) FDA approvals for NSCLC, now with the only FDA-approved CDx for targeted breast cancer therapy in ESR1 mutations.1,6,7

Identify biomarkers to pair patients with targeted therapies1,6-8

Lung cancer
Lung cancerEGFR exon
19 deletions,
L858R, and
EGFR exon 20 insertionsRYBREVANT®
ERBB2/HER2 activating mutations
(SNVs and exon 20 insertions)
ERBB2/HER2 activating mutations
(SNVs and exon 20 insertions)
(fam-trastuzumab deruxtecan-nxki)
Breast cancer
Breast cancerESR1 missense mutations
between codons 310-547

Detect guideline-recommended genomic
biomarkers across all 4 major alteration classes.1

Guardant360 CDx detects actionable biomarkers in 55 FDA-approved, clinically relevant genes.1

Comprehensive support across the cancer continuum.

References: 1. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. July 2021. 2. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Accessed June 29, 2023. 3. Foundation Medicine. FoundationOne®Liquid CDx. Accessed June 29, 2023. 4. Cleveland Clinic. Liquid Biopsy. August 11, 2022. Accessed June 29, 2023. 5. Guardant360® CDx Instructions for Use. Guardant Health, Inc. Redwood City, CA. August 2022. 6. FDA Recently Approved Drugs. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. January 27, 2023. Accessed June 29, 2023. 7. FDA Recently Approved Devices. Guardant360 CDx – P200010/S008. September 12, 2022. 8. Dean L, Kane M. Trastuzumab Therapy and ERBB2 Genotype. January 5, 2021. Accessed June 29, 2023. 9. TAGRISSO® (osimertinib) Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October 2022. 10. RYBREVANT™ (amivantamab-vmjw) Prescribing Information. Janssen Biotech, Inc. Horsham, PA. December 2021. 11. ENHERTU® (fam-trastuzumab deruxtecan-nxki) Prescribing Information. Daiichi Sankyo, Inc. Basking Ridge, NJ. August 2022. 12. LUMAKRAS™ (sotorasib) Prescribing Information. Amgen Inc. Thousand Oaks, CA. May 2021. 13. ORSERDU™ (elacestrant) Prescribing Information. Stemline Therapeutics, Inc. New York, NY. January 2023.