GTR Test Accession:
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GTR000593451.1
NYS CLEP
CAP
Registered in GTR:
2021-08-06
View version history
GTR000593451.1,
registered in GTR:
2021-08-06
Last annual review date for the lab: 2022-07-08
Past due
LinkOut
At a Glance
Test purpose:
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Drug Response;
Mutation Confirmation;
Therapeutic management
Conditions (1):
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Solid tumor
Genes (1):
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EGFR (7p11.2)
Methods (4):
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Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Not provided
Clinical validity:
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1. See full FDA approved labeling: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019B.pdf
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by:
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Specimen Source:
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- Paraffin block
Who can order: Help
- Health Care Provider
- Licensed Physician
How to Order:
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Health Care Provider submits test requisition form (available on website)
Order URL
Order URL
Test service:
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comprehensive genomic profiling of tumor
Test development:
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FDA-reviewed (has FDA test name)
Informed consent required:
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Decline to answer
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,
Lab contact for this test,
Contact policy,
Test strategy
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 1
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 4
Method Category
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Test method
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Instrument *
Deletion/duplication analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Microsatellite instability testing (MSI)
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Sequence analysis of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose:
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Drug Response;
Mutation Confirmation;
Therapeutic management
Clinical validity:
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1. See full FDA approved labeling: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019B.pdf
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
View citations (2)
- https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=290
- https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=290
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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We provide the VUS but no additional information
We provide the VUS but no additional information
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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No.
No.
Recommended fields not provided:
Target population,
Is research allowed on the sample after clinical testing is complete?,
Sample negative report,
Sample positive report
Technical Information
Test Platform:
Illumina HiSeq 4000
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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1. See full FDA approved labeling: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019B.pdf
Assay limitations:
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1. See full FDA approved labeling: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019B.pdf
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
VUS:
Software used to interpret novel variations
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custom proprietary
custom proprietary
Recommended fields not provided:
Test Confirmation,
Citations to support assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
IVD - In Vitro Device.
FDA Review of (Item reviewed):
Assay(s)
FDA Regulatory Status:
FDA cleared/approved
Application number:
P170019
NYS CLEP Approval:
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Number:
Status: Exempt
Status: Exempt
Additional Information
Reviews:
Clinical resources:
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.