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HelpTest Code EGFRS EGFR Gene, Targeted Mutation Analysis, 51 Mutation Panel, Tumor
Necessary Information
Pathology report must accompany specimen for testing to be performed.
Specimen Required
Preferred: Submit 3, if available, or 2 of the following specimens.
Acceptable: Submit at least one of the following specimens.
Specimen Type: Tissue block
Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.
Specimen Type: Tissue slide
Source: FFPE tissue, cell block (prepared from fine-needle aspirate, or pleural fluid)
Slides: 1 Hematoxylin and eosin-stained and 5 unstained
Collection Instructions:
Submit the followings slides:
1 Slide stained with hematoxylin and eosin
AND
5 Unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.
Specimen Type: Cytology slide (direct smears; smears stained with Pap stain are not acceptable)
Slides: 2 Slides
Collection Instructions: Submit 2 slides stained with Diff Quik and coverslipped with a total of 5000 nucleated cells (preferred) or at least 3000 nucleated cells (minimum).
Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.
Additional Information: Cytology slides will not be returned. An image of the slides will be stored per regulatory requirements.
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)
Specimen 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 | ||
Reject Due To
| Specimens that have been decalcified (all methods) | Reject |
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.
Day(s) Performed
Monday through Friday
Report Available
4 to 7 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.