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Guardant Shield LDT
Clinical Genetic Test
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offered by
Guardant Health
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GTR Test Accession: Help GTR000603596.1
INHERITED DISEASECANCERDIGESTIVE SYSTEM ... View more
Last updated in GTR: 2022-12-02
View version history
Last annual review date for the lab: 2021-02-02 Past due LinkOut
At a Glance
Test purpose: Help
Screening
Conditions (1): Help
Colorectal cancer
Analytes (1): Help
Methylation Status
Methods (3): Help
Biochemical Genetics - Protein analysis: Fluorometry; ...
Target population: Help
Screen-relevant average-risk patients of either sex
Clinical validity: Help
Clinical validation demonstrated an overall sensitivity of 91% for CRC, …
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Guardant Health
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Health Care Provider
  • 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
Liquid biopsy testing for MRD
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
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, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Analytes Help
Total analytes: 1
Analyte Associated Condition
Methodology
Total methods: 3
Method Category Help
Test method Help
Instrument
Protein analysis
Fluorometry
Other
Methylation analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Other
Sequence analysis of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Other
Clinical Information
Test purpose: Help
Screening
Clinical validity: Help
Clinical validation demonstrated an overall sensitivity of 91% for CRC, 20% for AA, and 92% specificity for ACN with greater than 90% sensitivity for Stage I and Stage II CRC.
View citations (1)
  • J Clin Oncol 40, 2022 (suppl 16; abstr 3627)
Target population: Help
Screen-relevant average-risk patients of either sex
View citations (1)
  • JAMA. 2021;325(19):1978-1997. doi:10.1001/jama.2021.4417
Recommended fields not provided:
Clinical utility, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, 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
Plasma-derived cfDNA was profiled using a custom assay that enriches fragments with dense CpG methylation and further depletes uninformative background molecules containing unmethylated CpGs. cfDNA and protein results are integrated into a binary “abnormal” vs “normal” result using a proprietary bioinformatic pipeline.
View citations (1)
  • J Clin Oncol 40, 2022 (suppl 16; abstr 3627)
Test Platform:
Other
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical sensitivity, specificity, accuracy, precision, reference range and reportable range have been established using contrived controls, cancer patient samples, and healthy donor samples. Precision studies in 60 positive and 60 negative clinical sample replicates yielded > 95% average positive and negative percent agreement both within and between batches
View citations (1)
  • J Clin Oncol 40, 2022 (suppl 16; abstr 3627)
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, Assay limitations, Description of internal test validation method, 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: 94979
Status: Pending
Additional Information
Reviews:
Suggested reading:
Clinical resources:
Molecular resources:
Practice guidelines:
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.