GTR Test Accession:
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GTR000591172.1
CAP
Registered in GTR:
2020-07-01
View version history
GTR000591172.1,
registered in GTR:
2020-07-01
Last annual review date for the lab: 2023-06-14
Past due
LinkOut
At a Glance
Test purpose:
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Therapeutic management
Conditions (1):
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Lung carcinoma
6q22
Genes (1):
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EGFR (7p11.2)
Proteins (1):
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PDL1
Methods (3):
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Biochemical Genetics - Immunohistochemistry: mismatch repair proteins for MLH1, MSH2, MSH6, PMS2; ...
Target population: Help
patients with lung cancer diagnosis determining which treatment drug to …
Clinical validity:
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10% of patients with NSCLC have a mutation in EGFR
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test short name:
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LUNGC22
Specimen Source:
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- Fresh tissue
- Frozen tissue
- Paraffin block
Who can order: Help
- Health Care Provider
- Licensed Physician
- Physician Assistant
Test Order Code:
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Lung Cancer Driver Profile
CPT codes:
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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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Please include all these CPT codes for this panel:
81210x1, 81235 x1, 88381x1, G0452x1, 88377 x2, 88360 x1
contact us:
Toll Free: 855-GOPATH9
Fax: 224-588-9941
Links
www.gopathgenetics.com
we will sent up account for you to receive testing kits and requisitions.
Order URL
81210x1, 81235 x1, 88381x1, G0452x1, 88377 x2, 88360 x1
contact us:
Toll Free: 855-GOPATH9
Fax: 224-588-9941
Links
www.gopathgenetics.com
we will sent up account for you to receive testing kits and requisitions.
Order URL
Test service:
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molecular genomic testing
Test development:
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Manufactured (research use only; not FDA-reviewed)
Informed consent required:
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Based on applicable state law
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
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Chromosomal regions/Mitochondria
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Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion | Associated condition |
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Genes
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Total genes: 1
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Proteins
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Total proteins: 1
Protein | Associated Condition |
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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 VP 2000 PROCESSOR
Deletion/duplication analysis
PCR
ABI 3130XL Genetic Analyzer
Clinical Information
Test purpose:
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Therapeutic management
Clinical validity:
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10% of patients with NSCLC have a mutation in EGFR
Target population:
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patients with lung cancer diagnosis determining which treatment drug to use. Suggested therapy: erlotinib, afatinib, gefitinib.
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://www.ncbi.nlm.nih.gov/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://www.ncbi.nlm.nih.gov/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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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Yes. our GeneticsNow service covers it all - please use our website www.gopathlabs.com
Yes. our GeneticsNow service covers it all - please use our website www.gopathlabs.com
Recommended fields not provided:
Clinical utility,
Is research allowed on the sample after clinical testing is complete?,
Sample negative report,
Sample positive report
Technical Information
Test Platform:
NextGENe for CNV analysis
Test Confirmation:
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rerun sequencing/CNV analysis on same sample if sufficient otherwise a new sample is requested
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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test predicts 100% of prognosis and therapeutic methods
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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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:
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:
Not Applicable
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.