Guardant360® CDx

The first FDA-approved comprehensive liquid biopsy
for all advanced solid tumors.1,2

Order liquid and tissue comprehensive genomic profiling (CGP) at the same time for >50% faster
time-to-treatment vs tissue testing alone.3

Order a kit

  • FDA approved as a
    companion diagnostic
    for targeted treatment options.1,4,5

  • Minimally invasive, only
    requires 2 tubes of
    blood.6

  • Reliably assess biomarkers with CGP in just 7 days to guide treatment selection.1,7

FDA approved companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed.1,4,5,8

NEWLY APPROVED

Biomarker Therapy
Breast cancer
Breast cancer ESR1 missense mutations
between codons 310-547 		ORSERDU™
(elacestrant)
Biomarker Therapy
Lung cancer
Lung cancer EGFR exon
19 deletions,
L858R, and
T790M*		TAGRISSO®
(osimertinib)
EGFR exon 20 insertions RYBREVANT®
(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 G12C LUMAKRAS™
(sotorasib)

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

Genes containing alterations reported by
Guardant360 CDx, with FDA approval for 55 genes.1

Single Nucleotide Variants (SNVs) Single Nucleotide Variants (SNVs)
AKT1ESR1NF1
ALKFGFR1NFE2L2
APCFGFR2NRAS
ARFGFR3NTRK1
ARAFGATA3NTRK3
ATM†GNA11PDGFRA
BRAFGNAQPIK3CA
BRCA1‡HRASPTEN
BRCA2‡IDH1RAF1
CCND1IDH2RET
CDH1KITRHEB
CDK4KRASROS1
CDK6MAP2K1SMAD4
CDK12†MAP2K2SMO
CDKN2AMETSTK11
CTNNB1MLH1TERT
EGFRMTORTSC1
ERBB2MYCVHL
AKT1BRAFCDK6ESR1GNAQMAP2K1NF1PIK3CASMAD4
ALKBRCA1‡CDK12†FGFR1HRASMAP2K2NFE2L2PTENSMO
APCBRCA2‡CDKN2AFGFR2IDH1METNRASRAF1STK11
ARCCND1CTNNB1FGFR3IDH2MLH1NTRK1RETTERT
ARAFCDH1EGFRGATA3KITMTORNTRK3RHEBTSC1
ATM†CDK4ERBB2GNA11KRASMYCPDGFRAROS1VHL
Insertions and Deletions (Indels) Insertions and Deletions (Indels)
AKT1EGFRMLH1
ALKERBB2NF1
APCESR1PDGFRA
ATM*FGFR2PIK3CA
BRAFGATA3PTEN
BRCA1‡HNF1ARET
BRCA2‡HRASROS1
CDH1KITSTK11
CDK12†KRASTSC1
CDKN2AMETVHL
AKT1ATM*BRCA2†CDKN2AESR1HNF1AKRASNF1PTENSTK11
ALKBRAFCDH1EGFRFGFR2HRASMETPDGFRARETTSC1
APCBRCA1†CDK12*ERBB2GATA3KITMLH1PIK3CAROS1VHL
Copy Number Amplifications (CNAs)
ERBB2MET
Fusions Fusions
ALKNTRK1RET ROS1
NTRK1ROS1

Guardant360® CDx

Submit a form to order a
comprehensive liquid biopsy with
results in as soon as 7 days.1

Order a kit

Comprehensive support
across the cancer continuum.

  • Guardant Portal

    Covered by Medicare

    For all advanced solid tumors.

    Contact client services ›
  • Guardant Portal

    Guardant Portal

    Easy access to test ordering and
    management with simple order forms.

    Clear, concise reports, including therapy and clinical trial options.

    Sign in now ›
  • Collection

    Easy and Convenient Sample Collection

    A mobile phlebotomy service makes
    sample collection as easy and
    convenient as possible by meeting
    patients at their location.

    Inquire about mobile phlebotomy ›

*The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.1

†Reporting is enabled for pathogenic germline alterations only. Somatic alterations will not be reported.

‡Reporting is enabled for both germline and somatic alterations.

Gene charts are adapted from Guardant360 CDx Technical Information.

TAGRISSO® is a registered trademark of the AstraZeneca group of companies.9

RYBREVANT® is a registered trademark of Janssen Biotech, Inc.10

ENHERTU® is a registered trademark of Daiichi Sankyo Company, Limited.11

LUMAKRAS™ is a trademark of Amgen Inc.12

ORSERDU™ is a trademark of Stemline Therapeutics, a Menarini Group Company.13

For a full list of diagnoses, download the Controlled Language for Diagnosis page.

For a full list of medical articles and drugs' Prescribing Information,
download the Gene Pocket Guide Reference List.

References: 1. Guardant360 CDx Technical Information. Guardant Health, Inc. Palo Alto, CA. July 2021. 2. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Accessed October 31, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test 3. Cui W, Milner-Watts C, O'Sullivan H, et al. Up-front cell-free DNA next generation sequencing improves target identification in UK first line advanced non-small cell lung cancer (NSCLC) patients. Eur J Cancer. 2022;171:44-54. doi:10.1016/j.ejca.2022.05.012 4. FDA Recently Approved Devices. Guardant360 CDx – P200010/S008. September 12, 2022. https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s008 5. FDA Recently Approved Drugs. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. January 27, 2023. Accessed February 7, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer 6. Guardant360 CDx Instructions for Use. Guardant Health, Inc. Palo Alto, CA. August 2022. 7. Page RD, Drusbosky LM, Dada H, et al. Clinical outcomes for plasma-based comprehensive genomic profiling versus standard-of-care tissue testing in advanced non-small cell lung cancer. Clin Lung Cancer. 2022;23(1):72-81. doi:10.1016/j.cllc.2021.10.001 8. Dean L, Kane M. Trastuzumab Therapy and ERBB2 Genotype. January 5, 2021. Accessed: February 10, 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.