Guardant360 CDx Gene List
Guardant360 CDx is indicated to provide tumor mutation profiling for advanced cancer patients with any solid malignant neoplasm. A Guardant360 CDx report contains both professional services, which includes 74 genes, in addition to the FDA-approved report, which includes 55 genes.
All four major classes of alterations detected
Guardant360 TissueNext Gene List
Guardant360 TissueNext is an analytically validated tissue comprehensive genomic profiling panel that includes TMB, MSI status, and PD-L1 IHC, if ordered. A Guardant360 TissueNext report includes 84 genes.
All four major classes of alterations detected
Point Mutations (SNVs) and Deletion Variants (Indels)
(84 Genes)
AKT1
ALK
APC
AR
ARAF
ARID1A
ATM
BRAF
BRCA1
BRCA2
CCND1
CCND2
CCNE1
CDH1
CDK4
CDK6
CDK12
CDKN2A
CHEK2
CTNNB1
DDR2
EGFR
ERBB2
ESR1
EZH2
FANCA
FBXW7
FGFR1
FGFR2
FGFR3
GATA3
GNA11
GNAQ
GNAS
HNF1A
HRAS
IDH1
IDH2
JAK2
JAK3
KEAP1
KIT
KRAS
MAP2K1
MAP2K2
MAPK1
MAPK3
MET
MLH1
MPL
MSH6
MSH2
MTOR
MYC
MYCN
NF1
NFE2L2
NOTCH1
NPM1
NRAS
NTRK1
NTRK2
NTRK3
PALB2
PDGFRA
PIK3CA
PMS2
PTEN
PTPN11
RAD51D
RAF1
RB1
RET
RHEB
RHOA
RIT1
ROS1
SMAD4
SMO
STK11
TERT^
TP53
TSC1
VHL
Amplifications
(20 Genes)
AR
BRAF
CCND1
CCND2
CCNE1
CDK4
CDK6
EGFR
ERBB2
ESR1
FGFR1
FGFR2
KIT
KRAS
MET
MYC
MYCN
PDGFRA
PIK3CA
RAF1
Fusions
(12 Genes)
ALK
BRAF
EGFR
FGFR1
FGFR2
FGFR3
MET
NTRK1
NTRK2
NTRK3
RET
ROS1
PD-L1 status
(if ordered)
MSI status
Qualitative result
TMB status
Mutations per Megabase
NSCLC guideline-recommended genes shown in bold / ^ Includes TERT promoter region
Guardant360 TissueNext 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. This test has not been cleared or approved by the U.S. FDA.