GTR Test Accession:
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GTR000591175.1
Last updated in GTR: 2020-07-02
View version history
GTR000591175.1, last updated: 2020-07-02
Last annual review date for the lab: 2023-06-14
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At a Glance
Test purpose:
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Prognostic;
Therapeutic management
Conditions (1):
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Lung carcinoma
Genes (1):
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EGFR (7p11.2)
Methods (3):
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Biochemical Genetics - Immunohistochemistry: mismatch repair proteins for MLH1, MSH2, MSH6, PMS2; ...
Target population: Help
Lung Cancer patients specifically those with non-small cell lung carcinoma
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test short name:
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LUNGC23
Specimen Source:
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- Fresh tissue
- Frozen tissue
- Paraffin block
- View specimen requirements
Who can order: Help
- Health Care Provider
- Licensed Physician
Test Order Code:
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Lung Cancer Expanded Driver Profile
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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81210, 88377x2, 81235, 88360x1, 88368x1, 88377
Order URL
Order URL
Test service:
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Custom Sequence Analysis
Test additional service:
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Custom mutation-specific/Carrier testing
Informed consent required:
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No
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Lab contact for this test,
Test strategy,
Test development
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: 3
Method Category
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Test method
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Instrument
Immunohistochemistry
mismatch repair proteins for MLH1, MSH2, MSH6, PMS2
Fluorescence in situ hybridization (FISH)
Fluorescence in situ hybridization (FISH)
ABBOTT VP3000 Processor
Sequence analysis of select exons
PCR
ABI 3130XL Genetic Analyzer
Clinical Information
Test purpose:
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Prognostic;
Therapeutic management
Target population:
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Lung Cancer patients specifically those with non-small cell lung carcinoma
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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Interpretation and classification of clinical significance of the detected variant are based on catalogued information from the NCBI ClinVar database (http://0-www-ncbi-nlm-nih-gov.brum.beds.ac.uk/clinvar/variation/), LOVD database (http://databases.lovd.nl/ shared/genes/) and other locus specific databases as well as information from published literatures
Interpretation and classification of clinical significance of the detected variant are based on catalogued information from the NCBI ClinVar database (http://0-www-ncbi-nlm-nih-gov.brum.beds.ac.uk/clinvar/variation/), LOVD database (http://databases.lovd.nl/ shared/genes/) and other locus specific databases as well as information from published literatures
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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Yes.
Yes.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided. our GeneticsNow service covers it all - please use our website www.gopathlabs.com
Not provided. our GeneticsNow service covers it all - please use our website www.gopathlabs.com
Recommended fields not provided:
Clinical validity,
Clinical utility,
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 Platform:
NextGene
Availability:
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Tests performed
Entire test performed in-house
Test performance comments
Entire panel is performed in house except for MET FISH in the panel
Entire test performed in-house
Test performance comments
Entire panel is performed in house except for MET FISH in the panel
Analytical Validity:
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BRAF sensitivity 100% and specificity calculated at 98%.
EGFR sensitivity and specificity 100%.
FISH sensitivity and specificity 100%
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
CAP
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
CAP
VUS:
Software used to interpret novel variations
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NextGENe
Laboratory's policy on reporting novel variations Help
formal reports
NextGENe
Laboratory's policy on reporting novel variations Help
formal reports
Recommended fields not provided:
Test Confirmation,
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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Not provided
Additional Information
Reviews:
Suggested reading:
Clinical resources:
Molecular 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.