FoundationOne CDx
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000593451.1
NYS CLEP
CAP
Registered in GTR: 2021-08-06
Last annual review date for the lab: 2022-07-08 Past due LinkOut
At a Glance
Drug Response; Mutation Confirmation; Therapeutic management
Solid tumor
Genes (1): Help
EGFR (7p11.2)
Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Not provided
1. See full FDA approved labeling: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019B.pdf
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Foundation Medicine, Inc.
View lab's website
Specimen Source: Help
  • Paraffin block
Who can order: Help
  • Health Care Provider
  • Licensed Physician
How to Order: Help
Health Care Provider submits test requisition form (available on website)
Order URL
Test service: Help
comprehensive genomic profiling of tumor
Test development: Help
FDA-reviewed (has FDA 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:
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 1
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 4
Method Category Help
Test method Help
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: Help
Drug Response; Mutation Confirmation; Therapeutic management
Clinical validity: Help
1. See full FDA approved labeling: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019B.pdf
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (2)

Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
We provide the VUS but no additional information

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
No.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
No.
Recommended fields not provided:
Technical Information
Test Platform:
Illumina HiSeq 4000
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
1. See full FDA approved labeling: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019B.pdf
Assay limitations: Help
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? Help
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 Help
custom proprietary
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Category: IVD - In Vitro Device.
FDA Review of (Item reviewed): Assay(s)
FDA Regulatory Status: FDA cleared/approved
Application number: P170019
NYS CLEP Approval: Help
Number:
Status: Exempt
Additional Information

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