GTR Test Accession:
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GTR000593766.3
NYS CLEP
Last updated in GTR: 2022-11-30
View version history
GTR000593766.3, last updated: 2022-11-30
GTR000593766.2, last updated: 2022-11-28
GTR000593766.1, last updated: 2021-08-13
Last annual review date for the lab: 2021-02-02
Past due
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At a Glance
Test purpose:
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Monitoring;
Recurrence;
Therapeutic management
Conditions (1):
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Colorectal carcinoma
Analytes (1):
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Methylation Status
Methods (2):
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Molecular Genetics - Methylation analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Patients with early-stage colorectal, breast, and lung cancers.
Clinical validity:
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A total of 252 prospective serial plasma specimens from 103 …
Clinical utility:
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Guidance for management
Ordering Information
Offered by:
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Specimen Source:
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- Peripheral (whole) blood
- Plasma
- View specimen requirements
Who can order: Help
- Licensed Physician
Lab contact:
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Contact Policy:
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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:
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Licensed physician contacts Guardant Health client services for ordering information.
Order URL
Order URL
Test service:
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Liquid biopsy testing for somatic cancer gene variants
Liquid biopsy testing for MRD
Liquid biopsy testing for MRD
Test development:
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Test developed by laboratory (no manufacturer test name)
Informed consent required:
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Decline to answer
Test strategy:
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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. Turn around time for testing is 14 days.
View citations (2)
- Tsikitis VL, Larson DW, Huebner M, Lohse CM, Thompson PA. Predictors of recurrence free survival for patients with stage II and III colon cancer. BMC Cancer. 2014;14:336. doi:10.1186/1471-2407-14-336. Epub 2014 May 16. PMID: 24886281.
- Parikh AR, Van Seventer EE, Siravegna G, Hartwig AV, Jaimovich A, He Y, Kanter K, Fish MG, Fosbenner KD, Miao B, Phillips S, Carmichael JH, Sharma N, Jarnagin J, Baiev I, Shah YS, Fetter IJ, Shahzade HA, Allen JN, Blaszkowsky LS, Clark JW, Dubois JS, Franses JW, Giantonio BJ, Goyal L, Klempner SJ, Nipp RD, Roeland EJ, Ryan DP, Weekes CD, Wo JY, Hong TS, Bordeianou L, Ferrone CR, Qadan M, Kunitake H, Berger D, Ricciardi R, Cusack JC, Raymond VM, Talasaz A, Boland GM, Corcoran RB. Minimal Residual Disease Detection using a Plasma-only Circulating Tumor DNA Assay in Patients with Colorectal Cancer. Clin Cancer Res. 2021;27(20):5586-5594. doi:10.1158/1078-0432.CCR-21-0410. Epub 2021 Apr 29. PMID: 33926918.
Pre-test genetic counseling required:
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Decline to answer
Post-test genetic counseling required:
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Decline to answer
Recommended fields not provided:
Test Order Code
Conditions
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Total conditions: 1
| Condition/Phenotype | Identifier |
|---|
Test Targets
Analytes
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Total analytes: 1
| Analyte | Associated Condition |
|---|
Methodology
Total methods: 2
Method Category
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Test method
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Instrument
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:
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Monitoring;
Recurrence;
Therapeutic management
Clinical validity:
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A total of 252 prospective serial plasma specimens from 103 patients with colorectal cancer undergoing curative-intent surgery were analyzed and correlated with recurrence. Plasma-only MRD detection demonstrated favorable sensitivity and specificity for recurrence, comparable with tumor-informed approaches. Integrating analysis of epigenomic and genomic alterations enhanced sensitivity. These findings support the …
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View citations (1)
- Parikh AR, Van Seventer EE, Siravegna G, Hartwig AV, Jaimovich A, He Y, Kanter K, Fish MG, Fosbenner KD, Miao B, Phillips S, Carmichael JH, Sharma N, Jarnagin J, Baiev I, Shah YS, Fetter IJ, Shahzade HA, Allen JN, Blaszkowsky LS, Clark JW, Dubois JS, Franses JW, Giantonio BJ, Goyal L, Klempner SJ, Nipp RD, Roeland EJ, Ryan DP, Weekes CD, Wo JY, Hong TS, Bordeianou L, Ferrone CR, Qadan M, Kunitake H, Berger D, Ricciardi R, Cusack JC, Raymond VM, Talasaz A, Boland GM, Corcoran RB. Minimal Residual Disease Detection using a Plasma-only Circulating Tumor DNA Assay in Patients with Colorectal Cancer. Clin Cancer Res. 2021;27(20):5586-5594. doi:10.1158/1078-0432.CCR-21-0410. Epub 2021 Apr 29. PMID: 33926918.
Clinical utility:
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Target population:
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Patients with early-stage colorectal, breast, and lung cancers.
View citations (2)
- Tsikitis VL, Larson DW, Huebner M, Lohse CM, Thompson PA. Predictors of recurrence free survival for patients with stage II and III colon cancer. BMC Cancer. 2014;14:336. doi:10.1186/1471-2407-14-336. Epub 2014 May 16. PMID: 24886281.
- Parikh AR, Van Seventer EE, Siravegna G, Hartwig AV, Jaimovich A, He Y, Kanter K, Fish MG, Fosbenner KD, Miao B, Phillips S, Carmichael JH, Sharma N, Jarnagin J, Baiev I, Shah YS, Fetter IJ, Shahzade HA, Allen JN, Blaszkowsky LS, Clark JW, Dubois JS, Franses JW, Giantonio BJ, Goyal L, Klempner SJ, Nipp RD, Roeland EJ, Ryan DP, Weekes CD, Wo JY, Hong TS, Bordeianou L, Ferrone CR, Qadan M, Kunitake H, Berger D, Ricciardi R, Cusack JC, Raymond VM, Talasaz A, Boland GM, Corcoran RB. Minimal Residual Disease Detection using a Plasma-only Circulating Tumor DNA Assay in Patients with Colorectal Cancer. Clin Cancer Res. 2021;27(20):5586-5594. doi:10.1158/1078-0432.CCR-21-0410. Epub 2021 Apr 29. PMID: 33926918.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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Not relevant for this assay as somatic variants are not currently reported.
Not relevant for this assay as somatic variants are not currently reported.
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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Not relevant as germline variants are not currently reported.
Not relevant as germline variants are not currently reported.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided.
Not provided.
Recommended fields not provided:
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:
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Cell free DNA is isolated from whole blood and then subjected to methylation partitioning. Following DNA library preparation, next generation sequencing of specific gene regions is performed. Reports provide presence / absence of ctDNA.
Test Platform:
None/not applicable
Test Comments:
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Guardant Reveal uses circulating tumor DNA (ctDNA) from liquid biopsy to detect presence of minimum residual disease and monitor for recurrence after definitive surgical / systemic therapy for patients with colorectal, breast or lung cancer.
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Analytical sensitivity, specificity, accuracy, precision, reference range and reportable range have been established using contrived controls, cancer patient samples, and healthy donor samples. Over 190 samples have been used to date in these validity studies
Assay limitations:
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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 result in reduced analytic sensitivity.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Alternative Assessment
Description of PT method: Help
Remnant samples are blind tested in the CLIA laboratory.
Yes
Method used for proficiency testing: Help
Alternative Assessment
Description of PT method: Help
Remnant samples are blind tested in the CLIA laboratory.
Recommended fields not provided:
Test Confirmation,
Citations to support assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
PT Provider,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
FDA exercises enforcement discretion
NYS CLEP Approval:
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Number:
81339
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.