• Covers all guideline-recommended biomarkers.1

  • Results in 2 to 3 weeks.1‡

  • Features a multi-cancer AI-powered scoring algorithm for PD-L1.

  • Medicare coverage for all advanced solid tumors.||

The Guardant360 TissueNext CGP covers clinically relevant biomarkers, including TMB, MSI, and PD-L1.1*

NSCLC guideline-recommended genes are shown in bold.

Single Nucleotide Variants (SNVs) and Insertions and Deletions (Indels) (84 genes)Single Nucleotide Variants (SNVs) and Insertions and Deletions (Indels)
(84 genes)
AKT1EGFRKRASPALB2
ALKERBB2MAP2K1PDGFRA
APCESR1MAP2K2PIK3CA
AREZH2MAPK1PMS2
ARAFFANCAMAPK3PTEN
ARID1AFBXW7METPTPN11
ATMFGFR1MLH1RAD51D
BRAFFGFR2MPLRAF1
BRCA1FGFR3MSH6RB1
BRCA2GATA3MSH2RET
CCND1GNA11MTORRHEB
CCND2GNAQMYCRHOA
CCNE1GNASMYCNRIT1
CDH1HNF1ANF1ROS1
CDK4HRASNFE2L2SMAD4
CDK6IDH1NOTCH1SMO
CDK12IDH2NPM1STK11
CDKN2AJAK2NRASTERT**
CHEK2JAK3NTRK1TP53
CTNNB1KEAP1NTRK2TSC1
DDR2KITNTRK3VHL
AKT1CCND2ERBB2GNASMAP2K2NF1PMS2SMAD4
ALKCCNE1ESR1HNF1AMAPK1NFE2L2PTENSMO
APCCDH1EZH2HRASMAPK3NOTCH1PTPN11STK11
ARCDK4FANCAIDH1METNPM1RAD51DTERT**
ARAFCDK6FBXW7IDH2MLH1NRASRAF1TP53
ARID1ACDK12FGFR1JAK2MPLNTRK1RB1TSC1
ATMCDKN2AFGFR2JAK3MSH6NTRK2RETVHL
BRAFCHEK2FGFR3KEAP1MSH2NTRK3RHEB
BRCA1CTNNB1GATA3KITMTORPALB2RHOA
BRCA2DDR2GNA11KRASMYCPDGFRARIT1
CCND1EGFRGNAQMAP2K1MYCNPIK3CAROS1
Copy Number Amplifications (CNAs)
(20 genes)
Copy Number Amplifications (CNAs)
(20 genes)
ARBRAF
CCND1CCND2
CCNE1CDK4
CDK6EGFR
ERBB2ESR1
FGFR1FGFR2
KITKRAS
METMYC
MYCNPDGFRA
PIK3CARAF1
ARBRAF
CCND1CCND2
CCNE1CDK4
CDK6EGFR
ERBB2ESR1
FGFR1FGFR2
KITKRAS
METMYC
MYCNPDGFRA
PIK3CARAF1
Fusions
(12 genes)
Fusions
(12 genes)
ALKMET
BRAFNTRK1
EGFRNTRK2
FGFR1NTRK3
FGFR2RET
FGFR3ROS1
ALKMET
BRAFNTRK1
EGFRNTRK2
FGFR1NTRK3
FGFR2RET
FGFR3ROS1
MSI StatusMSI Status
Qualitative result
Qualitative result
TMBTMB
Mutations per megabase
Mutations per megabase

NEW

PD-L1 StatusPD-L1 Status
AI-powered PD-L1 test is now validated for multiple tumor types.
AI-powered PD-L1 test is now validated for multiple tumor types.
Guardant Galaxy™ PD-L1

Submit samples for processing with as low as 10% tumor fraction.

Testing specifications for Guardant360 TissueNext:

FFPE tissue block or unstained slides

  • 11 slides for tissue CGP only

  • 15 slides for tissue CGP + PD-L1

References: 1. Guardant360 TissueNext™ Assay Specifications. Guardant Health, Inc. Redwood City, CA. 2. Guardant Galaxy Flyer. Guardant Health, Inc. Redwood City, CA. 3. Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. July 2021.