Skip to content

The first IVDR certified and FDA-approved comprehensive liquid biopsy
for all advanced solid tumours.1,2,3

  • CE-marked as a companion diagnostic for targeted treatment options.1,2,3
  • Minimally invasive, only requires 2 tubes of blood.1
  • Reliably assess biomarkers with CGP in just 5 days to guide treatment selection.5

IVDR cerified companion diagnostic to identify
patients who may benefit from treatment
with the targeted therapies listed.1,2,3

BiomarkerTherapy
Non-small cell lung cancer (NSCLC)EGFR exon 19 deletions,
L858R, and T790M*
TAGRISSO®
(osimertinib)
EGFR exon 20 insertionsRYBREVANT®
(amivantamab-vmjw)
KRAS G12CLUMAKRAS™
(sotorasib)
Breast cancerESR1 missense mutations between codons 310-547ORSERDU™
(elacestrant)

Genes containing alterations reported by Guardant360® CDx1

Point Mutations and InDels
(Complete or Critical Exon Coverage in 74 Genes)
ΑΚΤ1CDH1FGFR2KRASNPM1RIT1
ALKCDK4FGFR3MAP2K1NRASROS1
APCCDK6GATA3MAP2K2NTRK1SMAD4
ARCDK12GNA11MAPK1NTRK3SMO
ARAFCDKN2AGNAQMAPK3PDGFRASTK11
ARID1ACTNNB1GNASMETPIK3CATERT
ATMDDR2ΗΝF1ΑMLH1PTENTP53
BRAFEGFRHRASMPLPTPN11TSC1
BRCA1ERBB2IDH1MTORRAF1VHL
BRCA2ESR1IDH2MYCRB1
CCND1EZH2JAK2NF1RET
CCND2FBXW7JAK3NFE2L2RHEB
CCNE1FGFR1KITNOTCH1RHOA
Amplifications
(18 Genes)
ARFGFR1
BRAFFGFR2
CCND1KIT
CCND2KRAS
CCNE1MET
CDK4MYC
CDK6PDGFRA
EGFRPIK3CA
ERBB2RAF1
Fusions

(6 Genes)
ALK
FGFR2
FGFR3
NTRK1
RET
ROS1

Microsatellite Instability (MSI-High)

Comprehensive support
across the cancer continuum.

Easy and Convenient Sample Collection

Guardant Health Portal

All your patient reports.
One clear view.

Sign in now ›

References: 1. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. February 2023., 2. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Updated August 11, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test, 3. Guardant Health press release. Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications. May 21, 2024. https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Health-Receives-EU-IVDR-Certification-for-Guardant360-CDx-Liquid-Biopsy-for-Tumor-Mutation-Profiling-Across-All-Solid-Cancers-and-Companion-Diagnostic-Indications/default.aspx, 4. 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 NSCLC patients. Eur J Cancer. 2022;171:44-54.doi:10.1016/j.ejca.2022.05.012., 5. Guardant Health data on file. September 27, 2024. Guardant Health, Inc. Redwood City, CA.