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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| AKT1 | FGFR2 | NOTCH1 | |||||||||
| ALK | FGFR3 | NPM1 | |||||||||
| APC | GATA3 | NRAS | |||||||||
| AR | GNA11 | NTRK1 | |||||||||
| ARAF | GNAQ | NTRK2 | |||||||||
| ARID1A | GNAS | NTRK3 | |||||||||
| ATM | HNF1A | PALB2 | |||||||||
| BRAF | HRAS | PDGFRA | |||||||||
| BRCA1 | IDH1 | PIK3CA | |||||||||
| BRCA2 | IDH2 | PMS2 | |||||||||
| CCND1 | JAK2 | PTEN | |||||||||
| CCND2 | JAK3 | PTPN11 | |||||||||
| CCNE1 | KEAP1 | RAD51D | |||||||||
| CDH1 | KIT | RAF1 | |||||||||
| CDK12 | KRAS | RB1 | |||||||||
| CDK4 | MAP2K1 | RET | |||||||||
| CDK6 | MAP2K2 | RHEB | |||||||||
| CDKN2A | MAPK1 | RHOA | |||||||||
| CHEK2 | MAPK3 | RIT1 | |||||||||
| CTNNB1 | MET | ROS1 | |||||||||
| DDR2 | MLH1 | SMAD4 | |||||||||
| EGFR | MPL | SMO | |||||||||
| ERBB2 | MSH2 | STK11 | |||||||||
| ESR1 | MSH6 | TERT | |||||||||
| EZH2 | MTOR | TP53 | |||||||||
| FANCA | MYC | TSC1 | |||||||||
| FBXW7 | NF1 | VHL | |||||||||
| FGFR1 | NFE2L2 | ||||||||||
| AKT1 | CCND1 | DDR2 | GATA3 | KEAP1 | MSH2 | NTRK2 | RB1 | TP53 | |||
| ALK | CCND2 | EGFR | GNA11 | KIT | MSH6 | NTRK3 | RET | TSC1 | |||
| APC | CCNE1 | ERBB2 | GNAQ | KRAS | MTOR | PALB2 | RHEB | VHL | |||
| AR | CDH1 | ESR1 | GNAS | MAP2K1 | MYC | PDGFRA | RHOA | ||||
| ARAF | CDK12 | EZH2 | HNF1A | MAP2K2 | NF1 | PIK3CA | RIT1 | ||||
| ARID1A | CDK4 | FANCA | HRAS | MAPK1 | NFE2L2 | PMS2 | ROS1 | ||||
| ATM | CDK6 | FBXW7 | IDH1 | MAPK3 | NOTCH1 | PTEN | SMAD4 | ||||
| BRAF | CDKN2A | FGFR1 | IDH2 | MET | NPM1 | PTPN11 | SMO | ||||
| BRCA1 | CHEK2 | FGFR2 | JAK2 | MLH1 | NRAS | RAD51D | STK11 | ||||
| BRCA2 | CTNNB1 | FGFR3 | JAK3 | MPL | NTRK1 | RAF1 | TERT | ||||
Liquid comprehensive genomic profiling (CGP) provides guideline-complete genotyping more often than tissue-only testing.2
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
vs
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
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.
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.