Guardant360®

A comprehensive liquid biopsy
that
identifies actionable
biomarkers to guide therapeutic decision-making.1,2

Liquid comprehensive genomic profiling (CGP) informs treatment decisions in 18 days vs 31 days with tissue testing2,3*

*Non-small cell lung cancer patients who are negative from a plasma specimen for EGFR exon 19 deletions, L858R, T790M, EGFR exon 20 insertions, ERBB2/HER2 activating mutations, and KRAS G12C should be reflexed to tissue biopsy testing using an FDA-approved tumor tissue test, if feasible.4 Note that “tissue CGP,” known as Guardant360 TissueNextTM, and “liquid CGP," known as Guardant360, have not been cleared or approved by the FDA. For the complete intended use statement including companion diagnostic indications, please see Guardant360 CDx Technical Information: Guardant360CDx.com/technicalinfo.

Important Note: The Guardant360 test was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. Guardant360 refers to Guardant360 Laboratory Developed Test (LDT). This test has not been cleared or approved by the US FDA.

  • For patients with advanced-stage cancer, especially those who have progressed on therapy.1

  • Detects an expanded panel
    of biomarkers, including:

    Tumor mutation burden (TMB)5

    Microsatellite instability-high status (MSI)1

    Expanded homologous recombinational repair (HRR) gene set6

    Coverage of neurotrophic tyrosine receptor kinase (NTRK) fusions7

  • Get test results in 10 days.

An expanded panel of biomarkers

Guardant360 covers 83 genes, including these genes from the Guardant360® CDx panel: TMB, MSI, and HRR. Guardant360 CDx is approved for 55 genes.4,5

Guardant360 Panel1,7 Guardant360 Panel1,7
AKT1FGFR2 NOTCH1
ALKFGFR3 NPM1
APCGATA3 NRAS
ARGNA11 NTRK1
ARAFGNAQ NTRK2
ARID1AGNAS NTRK3
ATMHNF1A PALB2
BRAFHRAS PDGFRA
BRCA1IDH1 PIK3CA
BRCA2IDH2 PMS2
CCND1JAK2 PTEN
CCND2JAK3 PTPN11
CCNE1KEAP1 RAD51D
CDH1KIT RAF1
CDK12KRAS RB1
CDK4MAP2K1 RET
CDK6MAP2K2 RHEB
CDKN2AMAPK1 RHOA
CHEK2MAPK3 RIT1
CTNNB1MET ROS1
DDR2MLH1 SMAD4
EGFRMPL SMO
ERBB2MSH2 STK11
ESR1MSH6 TERT
EZH2MTOR TP53
FANCAMYC TSC1
FBXW7NF1 VHL
FGFR1NFE2L2
AKT1CCND1 DDR2 GATA3 KEAP1 MSH2 NTRK2 RB1 TP53
ALKCCND2 EGFR GNA11 KIT MSH6 NTRK3 RET TSC1
APCCCNE1 ERBB2 GNAQ KRAS MTOR PALB2 RHEB VHL
ARCDH1 ESR1 GNAS MAP2K1 MYC PDGFRA RHOA
ARAFCDK12 EZH2 HNF1A MAP2K2 NF1 PIK3CA RIT1
ARID1ACDK4 FANCA HRAS MAPK1 NFE2L2 PMS2 ROS1
ATMCDK6 FBXW7 IDH1 MAPK3 NOTCH1 PTEN SMAD4
BRAFCDKN2A FGFR1 IDH2 MET NPM1 PTPN11 SMO
BRCA1CHEK2 FGFR2 JAK2 MLH1 NRAS RAD51D STK11
BRCA2CTNNB1 FGFR3 JAK3 MPL NTRK1 RAF1 TERT

Liquid comprehensive genomic profiling (CGP) provides guideline-complete genotyping more often than tissue-only testing.2

Graph comparing liquid and tissue CGP in genotyping

Resulted in guideline-complete genotyping in 95% of patients, compared with 18% in patients with tissue genotyping alone (n=268 for ctDNA arm; n=51 for tissue arm)2

Liquid CGP informs
treatment decisions sooner than tissue testing.3

  • Circles comparing result turnaround between Guardant360 liquid CGP and tissue CGP

    vs

  • Circles comparing result turnaround between Guardant360 liquid CGP versus tissue CGP

Patients tested with Guardant360
initiated targeted therapy
approximately 18 days following testing, compared with 31 days for those who underwent tissue biopsies. All patients responded to targeted
therapy similarly regardless of biopsy type.3

Treatment response results are comparable between liquid CGP and tissue testing.8

PFS rates in patients receiving
targeted therapy,
based on results from tissue vs ctDNA
testing8

Graph comparing percentage of patient survival between tissue and ctDNA testing

Guardant360®

Get results in as little as 10 days.

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.

    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 ›
References: 1. Guardant360® Assay Specifications. Guardant Health, Inc. Palo Alto, CA. 2. Leighl NB, Page RD, Raymond VM, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer. Clin Cancer Res. 2019;25(15):4691-4700. doi:10.1158/1078-0432.CCR-19-0624 3. 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 4. Guardant360 CDx Technical Information. Guardant Health, Inc. Palo Alto, CA. July 2021. 5. Guardant360. National Library of Medicine. Bethesda, MD. August 2021. 6. Heeke AL, Pishvaian MJ, Lynce F, et al. Prevalence of homologous recombination-related gene mutations across multiple cancer types. JCO Precis Oncol. 2018;2:1-13. doi:10.1200/PO.17.00286 7. Guardant360 Gene Pocket Guide. Guardant Health, Inc. Palo Alto, CA. 8. Palmero R, Taus A, Viteri S, et al. Biomarker discovery and outcomes for comprehensive cell-free circulating tumor DNA versus standard-of-care tissue testing in advanced non-small-cell lung cancer. JCO Precis Oncol. 2021;5:93-102. doi:10.1200/PO.20.00241