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
FDA approved as a
companion diagnostic
for targeted treatment options.1,4,5Minimally invasive, only
requires 2 tubes of
blood.6Reliably 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) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
AKT1 | ESR1 | NF1 | ||||||||||
ALK | FGFR1 | NFE2L2 | ||||||||||
APC | FGFR2 | NRAS | ||||||||||
AR | FGFR3 | NTRK1 | ||||||||||
ARAF | GATA3 | NTRK3 | ||||||||||
ATM† | GNA11 | PDGFRA | ||||||||||
BRAF | GNAQ | PIK3CA | ||||||||||
BRCA1‡ | HRAS | PTEN | ||||||||||
BRCA2‡ | IDH1 | RAF1 | ||||||||||
CCND1 | IDH2 | RET | ||||||||||
CDH1 | KIT | RHEB | ||||||||||
CDK4 | KRAS | ROS1 | ||||||||||
CDK6 | MAP2K1 | SMAD4 | ||||||||||
CDK12† | MAP2K2 | SMO | ||||||||||
CDKN2A | MET | STK11 | ||||||||||
CTNNB1 | MLH1 | TERT | ||||||||||
EGFR | MTOR | TSC1 | ||||||||||
ERBB2 | MYC | VHL | ||||||||||
AKT1 | BRAF | CDK6 | ESR1 | GNAQ | MAP2K1 | NF1 | PIK3CA | SMAD4 | ||||
ALK | BRCA1‡ | CDK12† | FGFR1 | HRAS | MAP2K2 | NFE2L2 | PTEN | SMO | ||||
APC | BRCA2‡ | CDKN2A | FGFR2 | IDH1 | MET | NRAS | RAF1 | STK11 | ||||
AR | CCND1 | CTNNB1 | FGFR3 | IDH2 | MLH1 | NTRK1 | RET | TERT | ||||
ARAF | CDH1 | EGFR | GATA3 | KIT | MTOR | NTRK3 | RHEB | TSC1 | ||||
ATM† | CDK4 | ERBB2 | GNA11 | KRAS | MYC | PDGFRA | ROS1 | VHL |
Insertions and Deletions (Indels) | Insertions and Deletions (Indels) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
AKT1 | EGFR | MLH1 | ||||||||||
ALK | ERBB2 | NF1 | ||||||||||
APC | ESR1 | PDGFRA | ||||||||||
ATM* | FGFR2 | PIK3CA | ||||||||||
BRAF | GATA3 | PTEN | ||||||||||
BRCA1‡ | HNF1A | RET | ||||||||||
BRCA2‡ | HRAS | ROS1 | ||||||||||
CDH1 | KIT | STK11 | ||||||||||
CDK12† | KRAS | TSC1 | ||||||||||
CDKN2A | MET | VHL | ||||||||||
AKT1 | ATM* | BRCA2† | CDKN2A | ESR1 | HNF1A | KRAS | NF1 | PTEN | STK11 | |||
ALK | BRAF | CDH1 | EGFR | FGFR2 | HRAS | MET | PDGFRA | RET | TSC1 | |||
APC | BRCA1† | CDK12* | ERBB2 | GATA3 | KIT | MLH1 | PIK3CA | ROS1 | VHL |
Copy Number Amplifications (CNAs) | |
---|---|
ERBB2 | MET |
Fusions | Fusions | ||||||
---|---|---|---|---|---|---|---|
ALK | NTRK1 | RET | ROS1 | ||||
NTRK1 | ROS1 |
Submit a form to order a
comprehensive liquid biopsy with
results in as soon as 7 days.1
Comprehensive support
across the cancer continuum.
Covered by Medicare
Contact client services ›For all advanced solid tumors.
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 ›Easy and Convenient Sample Collection
A mobile phlebotomy service makes
Inquire about mobile phlebotomy ›
sample collection as easy and
convenient as possible by meeting
patients at their location.
*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.