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HelpTest ID: EGFRS EGFR Gene, Targeted Mutation Analysis, 51 Mutation Panel, Tumor
Necessary Information
Pathology report must accompany specimen for testing to be performed.
Specimen Required
Submit only 1 of the following specimens:
Preferred:
Specimen Type: Tissue, smear stained with Diff Quik, fine needle aspirate (FNA), or pleural fluid in cell blocks
Container/Tube: Tissue block
Collection Instructions: Submit a formalin-fixed, paraffin-embedded (FFPE) tissue block.
Acceptable:
Specimen Type: Tissue, smear stained with Diff Quik, FNA, or pleural fluid in cell block or cytology blood smear
Container/Tube: Slides
Specimen Volume: 1 Hematoxylin and eosin stained and 5 unstained
Collection Instructions:
1. For FFPE tissue, FNA or pleural fluid: Submit 1 slide stained with hematoxylin and eosin and 5 unstained, non-baked slides with 5 to 10-micron thick sections of the tumor tissue.
2. For cytology blood smear: Submit up to 2 slides stained with Diff Quik
Useful For
Identifying non-small cell lung cancers that may respond to epidermal growth factor receptor-targeted therapies
Additional Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| SLIRV | Slide Review in MG | No, (Bill Only) | Yes |
Testing Algorithm
When this test is ordered, slide review will always be performed at an additional charge.
Method Name
Polymerase Chain Reaction (PCR)
Reporting Name
EGFR Gene, Mutation Analysis, TumorSpecimen Type
VariesSpecimen Minimum Volume
Formalin-fixed, paraffin-embedded tissue block or Slides: see Specimen Required
Cytology smear stained with Diff Quik: >1000 cells
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | ||
| Refrigerated | |||
Clinical Information
Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the US Food and Drug Administration for treatment of specific cancers. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks.
Epidermal growth factor receptor (EGFR) protein is activated by the binding of specific ligands, resulting in activation of the RAS/MAPK pathway. Activation of this pathway induces a signaling cascade ultimately leading to cell proliferation. Dysregulation of the RAS/MAPK pathway is a key factor in tumor progression for many solid tumors. Targeted therapies directed to tumors harboring activating mutations within the EGFR tyrosine kinase domain (exons 18-21) have demonstrated some success in treating a subset of patients with non-small cell lung cancer.
As a result, the mutation status of EGFR can be a useful marker by which patients are selected for EGFR-targeted therapy.
Reference Values
An interpretive report will be provided.
Interpretation
The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.
Clinical Reference
1. Sharma SV, Bell DW, Settleman J, Haber DA. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer. 2007;7(3):169-181. doi:10.1038/nrc2088
2. Gao G, Ren S, Li A, et al. Epidermal growth factor receptor-tyrosine kinase inhibitor therapy is effective as first- line treatment of advanced non-small-cell lung cancer with mutated EGFR: a meta-analysis from six phase III randomized controlled trials. Int J Cancer. 2012;131(5):E822-829. doi:10.1002/ijc.27396
3. Mok TS. Personalized medicine in lung cancer: what we need to know. Nat Rev Clin Oncol. 2011;8(11):661-668. doi:10.1038/nrclinonc.2011.126
4. Lee CS, Sharma S, Miao E, Mensah C, Sullivan K, Seetharamu N. A comprehensive review of contemporary literature for epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer and their toxicity. Lung Cancer (Auckl). 2020;11:73-103. doi:10.2147/LCTT.S258444
Day(s) Performed
Monday through Friday
Report Available
4 to 7 daysCPT Code Information
81235-EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q)
88381-Microdissection, manual
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| EGFRS | EGFR Gene, Mutation Analysis, Tumor | 21665-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 616123 | Result Summary | 50397-9 |
| 616124 | Result | 21665-5 |
| 616125 | Interpretation | 69047-9 |
| 616126 | Specimen | 31208-2 |
| 616127 | Source | 31208-2 |
| 616128 | Tissue ID | 80398-1 |
| 616129 | Released By | 18771-6 |
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
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