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Test 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.

 


Secondary ID

614665

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, Tumor

Specimen Type

Varies

Specimen 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

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

4 to 7 days

Performing 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

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.