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EGFR targeted variants
Clinical Genetic Test
Help
offered by
CIBIC S.A.
View lab's test page
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GTR Test Accession: Help GTR000500500.2
CANCERRESPIRATORY DISEASE
Last updated in GTR: 2023-05-22
View version history
Last annual review date for the lab: 2024-05-15 LinkOut
At a Glance
Test purpose: Help
Drug Response; Therapeutic management
Conditions (2): Help
Non-small cell lung carcinoma; EGFR-related lung cancer
Genes (1): Help
EGFR (7p11.2)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: PCR with allele specific hybridization
Target population: Help
Individuals with advanced NSCLC
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
CIBIC S.A.
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View lab's test page
Test short name: Help
EGFR: exon 18, 19, 20, 21
Manufacturer's name: Help
EGFR Mutation test v2 (Roche)
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
Test Order Code: Help
7059
Lab contact: Help
Analia Seravalle, BSc, Staff
aseravalle@cibic.com.ar
054-341-449-9944 ext 242
Contact Policy: Help
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: Help
Specimen type: Tissue block (formalin-fixed, paraffin-embedded) ship specimen at room temperature. Paraffin-embedded tissue slides (5 minimum, 7micron section). Send all slides within 5-7 days of cutting, ship specimen at room temperature.
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Test strategy, Test development
Conditions Help
Total conditions: 2
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: 1
Method Category Help
Test method Help
Instrument
Targeted variant analysis
PCR with allele specific hybridization
Roche LightCycler 480
Clinical Information
Test purpose: Help
Drug Response; Therapeutic management
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (1)
  • Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, Harris PL, Haserlat SM, Supko JG, Haluska FG, Louis DN, Christiani DC, Settleman J, Haber DA. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med. 2004;350(21):2129-39. doi:10.1056/NEJMoa040938. Epub 2004 Apr 29. PMID: 15118073.

Target population: Help
Individuals with advanced NSCLC
Recommended fields not provided:
Clinical validity, What is the protocol for interpreting a variation as a VUS?, 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
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical sensitivity 100% Analytical specificity 100%
View citations (1)
  • Inserto Cobas EGFR Mutation Test v2
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: Not Applicable
Additional Information

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.