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Test Code EGFRT EGFR Gene, Mutation Analysis, 29 Mutation Panel, Tumor

Useful For

Identifying non-small cell lung cancers that may respond to epidermal growth factor receptor-tyrosine kinase inhibitor 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) Analysis

Reporting Name

EGFR Gene, Mutation Analysis, Tumor

Specimen Type

Varies


Specimen Required


Pathology report must accompany specimen in order for testing to be performed.

 

Preferred:

Specimen Type: Tissue

Container/Tube: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block.

 

Acceptable:

Specimen Type: Tissue

Container/Tube: Slides

Specimen Volume: 1 stained and 5 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 5 unstained, non-baked slides with 5-micron thick sections of the tumor tissue.


Specimen Minimum Volume

Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or 1 slide stained with hematoxylin and eosin and 5 unstained, nonbaked slides with 5-microns thick sections of the tumor tissue.

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient (preferred)
  Frozen 
  Refrigerated 

Clinical Information

Lung cancer is the leading cause of cancer-related deaths in the world. Non-small cell lung cancer (NSCLC) represents 70% to 85% of all lung cancer diagnoses. Small molecular agents that target the tyrosine kinase domain of the epidermal growth factor receptor (EGFR) protein are approved for the treatment of locally advanced or metastatic NSCLC as a second- or third-line regimen. Subsequently, randomized trials have suggested that targeted agents alone or combined with chemotherapy may be beneficial in maintenance and first-line settings. Because the combination of targeted therapy and standard chemotherapy leads to an increase in toxicity and cost, strategies that help to identify the individuals most likely to benefit from targeted therapies are desirable.

 

EGFR is a growth factor receptor that 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 NSCLC by preventing adenosine 5'-triphosphate (ATP)-binding at the active site. Gefitinib and erlotinib have been approved by the FDA for use in treating patients with NSCLC who previously failed to respond to the traditional platinum-based doublet chemotherapy. These 2 drugs have also recently been shown to increase progression-free and overall survival in patients who receive EGFR-tyrosine kinase inhibitor therapy as a first-line therapy for the treatment of NSCLC.

 

Agents such as gefitinib and erlotinib, which prevent ATP binding to EGFR kinase, do not appear to have any meaningful inhibitor activity on tumors that demonstrate the presence of the specific drug-resistant EGFR mutation T790M. Therefore, current data suggest that the efficacy of EGFR-targeted therapies in NSCLC is confined to patients with tumors demonstrating the presence of EGFR- activating mutations such as L858R, L861Q, G719A/S/C, S768I or small deletions within exon 19 and the absence of the drug-resistant mutation T790M. 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) and Time(s) Performed

Monday through Friday; 10 a.m.

Analytic Time

5 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

EGFR Gene, Mutation Analysis, 29 Mutation Panel, Tumor 

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)

 

Slide Review

88381-Microdissection, manual

LOINC Code Information

Test ID Test Order Name Order LOINC Value
EGFRT EGFR Gene, Mutation Analysis, Tumor 21666-5

 

Result ID Test Result Name Result LOINC Value
53246 Result Summary 50397-9
53247 Result 21665-5
53248 Interpretation 69047-9
53249 Specimen 31208-2
53250 Source 31208-2
54442 Tissue ID 81178-6
53251 Released By 18771-6

NY State Approved

Yes