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HelpTest ID EGFRS EGFR Gene, Targeted Mutation Analysis, 51 Mutation Panel, Tumor
Necessary Information
Pathology report must accompany specimen in order 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, fine needle aspirate, or pleural fluid in cell block or cytology blood smear
Container/Tube: Slides
Specimen Volume: 1 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 5-10-micron thick sections of the tumor tissue.
2. For cytology blood smear: Submit up to 2 slides stained with Diff Quik
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
Secondary ID
614665Useful 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 |
|---|---|---|
| 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.
Cautions
A negative (wildtype) result does not rule out the presence of a mutation that may be present but below the limits of detection for this assay (approximately 10%).
A negative (wildtype) result does not rule out the presence of other activating mutations in the EGFR gene.
Not all patients that have activating EGFR mutations detected by this assay respond to EGFR-targeted therapies.
Rare polymorphisms exist that could lead to false-negative or false-positive results.
Day(s) Performed
Monday through Friday
Report Available
5 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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.CPT 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