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Guardant360 Response
Clinical Genetic Test
Help
offered by
Guardant Health
View lab's test page
LinkOut
GTR Test Accession: Help GTR000593444.2
NYS CLEP
Last updated in GTR: 2021-08-12
View version history
Last annual review date for the lab: 2021-02-02 Past due LinkOut
At a Glance
Test purpose: Help
Drug Response; Prognostic; Therapeutic management
Conditions (1): Help
Solid tumor
Genes (74): Help
AKT1 (14q32.33), ALK (2p23.2-23.1), APC (5q22.2), AR (Xq12), ARAF (Xp11.3), ...
Methods (2): Help
Molecular Genetics - Sequence analysis of select exons: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Patients undergoing therapy with advanced solid tumor malignancies.
Clinical validity: Help
The clinical validity of Guardant360 Response is supported by over …
Clinical utility: Help
Avoidance of invasive testing; 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
Liquid biopsy 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
An approved physician with a Guardant Health account uses the Guardant sample collection kit to obtain a whole blood sample from the patient. Following Guardant shipping instructions, the sample is sent directly to the laboratory at Guardant Health. A second analysis is performed early on in treatment to assess changes … View more
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
Genes Help
Total genes: 74
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument
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
Drug Response; Prognostic; Therapeutic management
Clinical validity: Help
The clinical validity of Guardant360 Response is supported by over 40 clinical studies in which the Guardant360 assay platform has been used to determine ctDNA changes in baseline and on‐treatment plasma samples. These studies were performed in multiple cancer types (including NSCLC, colorectal cancer, breast cancer, gastric cancer and others), … View more
Clinical utility: Help
Avoidance of invasive testing
View citations (1)

Guidance for management
View citations (1)

Target population: Help
Patients undergoing therapy with advanced solid tumor malignancies.
View citations (2)
  • Aggarwal C, Thompson JC, Chien AL, Quinn KJ, Hwang WT, Black TA, Yee SS, Christensen TE, LaRiviere MJ, Silva BA, Banks KC, Nagy RJ, Helman E, Berman AT, Ciunci CA, Singh AP, Wasser JS, Bauml JM, Langer CJ, Cohen RB, Carpenter EL. Baseline Plasma Tumor Mutation Burden Predicts Response to Pembrolizumab-based Therapy in Patients with Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2020;26(10):2354-2361. doi:10.1158/1078-0432.CCR-19-3663. Epub 2020 Feb 26. PMID: 32102950.
  • Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020;10(12):1842-1853. doi:10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14. PMID: 32816849.
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
Cell free DNA is isolated from whole blood. Following DNA library preparation, next generation sequencing of specific gene regions is performed to establish a baseline. Reports provide details of variants detected, a response score and any relevant clinical information
Test Platform:
None/not applicable
Test Comments: Help
The test detects single nucleotide variants in a targeted panel of 74 genes, and selected copy number variations, 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; CTNNB1; DDR2; EGFR; ERBB2; ESR1; EZH2; FBXW7; FGFR1; FGFR2; FGFR3; GATA3; GNA11; GNAQ; GNAS; HNF1A; HRAS; IDH1; IDH2; JAK2; JAK3; KIT; KRAS; MAP2K1; MAP2K2; MAPK1; MAPK3; MET; … View more
The following genes are also analyzed for copy number amplifications: AR; BRAF; CCND1; CCND2; CCNE1; CDK4; CDK6; EGFR; ERBB2; FGFR1; FGFR2; KIT; KRAS; MET; MYC; PDGFRA; PIK3CA; and RAF1.
The following genes are also analyzed for fusions/rearrangements: ALK; BRAF; EGFR; FGFR1; FGFR3; MET; NTRK1; 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; CTNNB1; DDR2; EGFR; ERBB2; ESR1; EZH2; FBXW7; FGFR1; FGFR2; FGFR3; GATA3; GNA11; GNAQ; GNAS; HNF1A; HRAS; IDH1; IDH2; JAK2; JAK3; KIT; KRAS; MAP2K1; MAP2K2; … View more
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
The minimum detectable mutant allele (limit of detection) is dependent on the patient's sample cell-free DNA concentration, which can vary from less than 10 to over 1000 genomic equivalents per mL of peripheral blood. Certain sample characteristics may interfere with the accurate determination of copy number variants. Certain sample or … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Alternative Assessment

Description of internal test validation method: Help
Remnant samples are blind tested in the CLIA laboratory.
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Citations to support 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: 84760
Status: Approved
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.