• First FDA-approved

    comprehensive liquid

    biopsy with broad

    Medicare coverage.2

  • Actionable results in 7

    days to guide treatment

    decisions.1*

  • Minimally invasive—only requires 2 tubes of blood.5

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

BiomarkerTherapy
Lung cancer
Lung cancerEGFR exon
19 deletions,
L858R, and
T790M
TAGRISSO®
(osimertinib)
EGFR exon 20 insertionsRYBREVANT®
(amivantamab-vmjw)
ERBB2/HER2 activating mutations
(SNVs and exon 20 insertions)
ERBB2/HER2 activating mutations
(SNVs and exon 20 insertions)
ENHERTU®
(fam-trastuzumab deruxtecan-nxki)
KRAS G12CLUMAKRAS
(sotorasib)
BiomarkerTherapy
Breast cancer
Breast cancerESR1 missense mutations
between codons 310-547
ORSERDU
(elacestrant)

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

Single Nucleotide Variants (SNVs)Single Nucleotide Variants (SNVs)
AKT1ESR1NF1
ALKFGFR1NFE2L2
APCFGFR2NRAS
ARFGFR3NTRK1
ARAFGATA3NTRK3
ATMGNA11PDGFRA
BRAFGNAQPIK3CA
BRCA1§HRASPTEN
BRCA2§IDH1RAF1
CCND1IDH2RET
CDH1KITRHEB
CDK4KRASROS1
CDK6MAP2K1SMAD4
CDK12MAP2K2SMO
CDKN2AMETSTK11
CTNNB1MLH1TERT
EGFRMTORTSC1
ERBB2MYCVHL
AKT1BRAFCDK6ESR1GNAQMAP2K1NF1PIK3CASMAD4
ALKBRCA1§CDK12FGFR1HRASMAP2K2NFE2L2PTENSMO
APCBRCA2§CDKN2AFGFR2IDH1METNRASRAF1STK11
ARCCND1CTNNB1FGFR3IDH2MLH1NTRK1RETTERT
ARAFCDH1EGFRGATA3KITMTORNTRK3RHEBTSC1
ATMCDK4ERBB2GNA11KRASMYCPDGFRAROS1VHL
Insertions and Deletions (Indels)Insertions and Deletions (Indels)
AKT1EGFRMLH1
ALKERBB2NF1
APCESR1PDGFRA
ATMFGFR2PIK3CA
BRAFGATA3PTEN
BRCA1§HNF1ARET
BRCA2§HRASROS1
CDH1KITSTK11
CDK12KRASTSC1
CDKN2AMETVHL
AKT1ATM BRCA2§CDKN2AESR1HNF1AKRASNF1PTENSTK11
ALKBRAFCDH1EGFRFGFR2HRASMETPDGFRARETTSC1
APCBRCA1§CDK12ERBB2GATA3KITMLH1PIK3CAROS1VHL
Copy Number Amplifications (CNAs)
ERBB2MET
ERBB2MET
Fusions
ALKNTRK1
RETROS1
ALKNTRK1RETROS1

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. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test 3. Foundation Medicine. FoundationOne®Liquid CDx. Accessed June 29, 2023. https://www.foundationmedicine.com/test/foundationone-liquid-cdx 4. Cleveland Clinic. Liquid Biopsy. August 11, 2022. Accessed June 29, 2023. https://my.clevelandclinic.org/health/diagnostics/23992-liquid-biopsy 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. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer 7. FDA Recently Approved Devices. Guardant360 CDx – P200010/S008. September 12, 2022. https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s008 8. Dean L, Kane M. Trastuzumab Therapy and ERBB2 Genotype. January 5, 2021. Accessed June 29, 2023. https://www.ncbi.nlm.nih.gov/books/NBK310376/#_NBK310376_pubdet 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.