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Guardant360 TissueNext
Clinical Genetic Test
Help
offered by
Guardant Health
View lab's test page
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GTR Test Accession: Help GTR000593772.1
Last updated in GTR: 2021-08-17
View version history
Last annual review date for the lab: 2021-02-02 Past due LinkOut
At a Glance
Test purpose: Help
Therapeutic management
Conditions (1): Help
Solid tumor
Analytes (3): Help
Microsatellite Instability; PD-1/PD-L1; Tumor mutational burden
Genes (84): Help
AKT1 (14q32.33), ALK (2p23.2-23.1), APC (5q22.2), AR (Xq12), ARAF (Xp11.3), ...
Methods (4): Help
Molecular Genetics - Methylation analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Patients with advanced solid-tumor cancers of all types when interrogation …
Clinical validity: Help
Matched tumor samples obtained for multiple cancer types in which …
Clinical utility: Help
Guidance for management
Ordering Information
Offered by: Help
Guardant Health
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Licensed Physician
Lab contact: Help
Martina Lefterova, MD, ABPath, FCAP, Lab Director
clientservices@guardanthealth.com
855-698-8887
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
Licensed physician contacts Guardant Health client services for ordering information.
Order URL
Test service: Help
Tissue testing for somatic cancer gene variants
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
Test strategy: Help
TissueNext testing algorithm is based on FDA-approved therapies and professional guidelines. When TissueNext is ordered and no actionable biomarker is identified with Guardant360 CDx, Guardant360 TissueNext will be run and reported when originally requested by the ordering provider.
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Analytes Help
Total analytes: 3
Analyte Associated Condition
Genes Help
Total genes: 84
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 4
Method Category Help
Test method Help
Instrument
Methylation analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Other
Microsatellite instability testing (MSI)
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Other
Sequence analysis of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Other
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Other
Clinical Information
Test purpose: Help
Therapeutic management
Clinical validity: Help
Matched tumor samples obtained for multiple cancer types in which variants were verified by external laboratories were used in clinical validity studies.
Clinical utility: Help
Guidance for management
View citations (1)

Target population: Help
Patients with advanced solid-tumor cancers of all types when interrogation of a concurrent Guardant360 liquid biopsy test is uninformative.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Somatic gene variants of uncertain significance are reported but not associated with FDA approved drugs or clinical trials. Only gene variants reported in the peer-reviewed literature as functional are associated with treatments or trials.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
No. Not relevant as germline variants are not currently reported.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Recommended fields not provided:
Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
gDNA is isolated from paraffin-embedded in tissue. Following DNA library preparation, next generation sequencing of specific gene regions is performed. Reports provide details of variants detected and any relevant clinical information.
Test Platform:
None/not applicable
Test Comments: Help
The test detects single nucleotide variants in a targeted panel of 84 genes, and selected copy number amplifications, fusions/rearrangements, and indels for a specific set of genes. All four types of genomic alterations are reported in a single test.
The following genes are sequenced: 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; … View more
The following genes are also analyzed for copy number amplifications: AR; BRAF; CCND1; CCND2; CCNE1; CDK4; CDK6; EGFR; ERBB2; ESR1; FGFR1; FGFR2; KIT; KRAS; MET; MYC; MYCN; PDGFRA; PIK3CA; and RAF1.
The following genes are also analyzed for fusions/rearrangements: ALK; BRAF; EGFR; FGFR1; FGFR2; FGFR3; MET; NTRK1; NTRK2; NTRK3; RET; and ROS1. The assay detects all known gene fusion partners for these rearrangements.
The following genes are also analyzed for indels: 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; … View more
In addition, Microsatellite Instability (MSI) is qualitatively assessed for all tumor types by evaluating somatic changes in the length of specific microsatellites (i.e. repetitive sequences).
Tumor mutational burden (TMB) score is calculated for all cancer types from somatic SNVs and indels in exons of the genes comprising the Guardant360 panel by adjusting for tumor shedding levels and the size of the panel.
Availability: Help
Tests performed
Entire test performed in-house

Test performance comments
The Guardant Health laboratory is located in Redwood City, California
Analytical Validity: Help
Analytical sensitivity, specificity, accuracy, precision, reference range and reportable range have been established using synthetic controls, cell lines, and tumor matched samples. Over 200 samples have been used to date in validity studies.
Assay limitations: Help
Certain sample characteristics may interfere with the accurate determination of copy number variants. Certain sample or variant characteristics may result in reduced analytic sensitivity.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Alternative Assessment
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number:
Status: Pending
Additional Information
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.