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Epidermal Growth Factor Receptor (EGFR) Gene Mutation Analysis, Non−Small-cell Lung Cancer (Single-base Extension)

Test Number 570186
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CPT

81235; 88381

To be determined. Updates will be made when available.

81235; 88381
Synonyms
  • Erlotinib Responsiveness in NSCLC, EGFR Mutation Analysis
  • Gefitinib Responsiveness in NSCLC, EGFR Mutation Analysis
  • IRESSA® Responsiveness in NSCLC, EGFR Mutation Analysis
  • Non−Small-cell Lung Cancer, EGFR Mutation
  • Tarceva® Responsiveness in NSCLC, EGFR Mutation Analysis
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  • Updated on 02/17/2025

Test Details

Methodology

SNaPshot Multiplex PCR (primer extension-based method)

Result Turnaround Time

5 - 7 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Information

Use

In non-small cell lung cancer, many mutations in EGFR are associated with responsiveness to EGFR tyrosine kinase inhibitor (TKI) therapy. In contrast, some mutations in EGFR are associated with resistance to EGFR TKI therapy, including T790M and EGFR exon 20 insertions. The T790M mutation is a known mechanism of resistance and is commonly associated with relapse following initial therapy with EGFR TKI.

Special Instructions

Please provide a copy of the pathology report. Please direct any questions regarding this test to customer service at 800-345-4363. A subsequent blood sample may be requested in order to confirm the somatic origin of an identified mutation.

Limitations

The EGFR test is designed to detect mutations in exon 18, 19, 20 and 21 of the EGFR gene. These mutations account for >99% of all reported EGFR mutations in NSCLC patients. Samples with results reported as "no mutation detected" may harbor EGFR mutations that are not detected by the assay.

Detection of mutation is dependent on sample integrity and the amount of amplifiable DNA present in the specimen. The methods used in this assay are highly selective and, depending on the total amount of DNA present, can detect approximately 2% to 20% of mutant in a background of wild-type genomic DNA.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

References

Lindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018 Mar;142(3):321-346. 29355391
 
NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 3.2020.
Lindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018 Mar;142(3):321-346. PubMed 29355391
 
NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 3.2020.
Lindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018 Mar;142(3):321-346. 29355391
 
NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 3.2020.

Specimen Requirements

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides from NSCLC

Volume

Five unstained slides and one matching H&E-stained slide at 10 μM or formalin-fixed, paraffin-embedded tissue block

Minimum Volume

Two unstained slides and one matching H&E-stained slide at 10 μM (samples with >4 mm² and ≥50% tumor content are preferred)

Container

Slides or blocks

Collection Instructions

Submit blocks/slides at room temperature.

Causes for Rejection

Tumor block containing insufficient tumor; tissue or tumor fixed in a heavy metal fixative; broken or stained slides

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
570186 EGFR Mutation Analysis, NSCLC 570187 Referring Physician 18781-5
570186 EGFR Mutation Analysis, NSCLC 570188 Treating Physician 18781-5
570186 EGFR Mutation Analysis, NSCLC 570189 Body Site 39111-0
570186 EGFR Mutation Analysis, NSCLC 570190 Client Specimen ID N/A
570186 EGFR Mutation Analysis, NSCLC 570191 Specimen(s) Received 31208-2
570186 EGFR Mutation Analysis, NSCLC 570192 Clinical Data 55752-0
570186 EGFR Mutation Analysis, NSCLC 570193 Results: 62365-2
570186 EGFR Mutation Analysis, NSCLC 570194 Interpretation 62365-2
570186 EGFR Mutation Analysis, NSCLC 570195 Analytical Results 21702-6
570186 EGFR Mutation Analysis, NSCLC 570196 Comments 77202-0
570186 EGFR Mutation Analysis, NSCLC 570197 Methodology: 49549-9
570186 EGFR Mutation Analysis, NSCLC 570198 References: 75608-0
570186 EGFR Mutation Analysis, NSCLC 570199 Signed By 19139-5
570186 EGFR Mutation Analysis, NSCLC 570200 Disclaimers N/A
570186 EGFR Mutation Analysis, NSCLC 570201 PDF 11502-2
570186 EGFR Mutation Analysis, NSCLC 570202 Bill Code Entry Hold N/A
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570187
Result Code NameReferring Physician
UofM
Result LOINC18781-5
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570188
Result Code NameTreating Physician
UofM
Result LOINC18781-5
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570189
Result Code NameBody Site
UofM
Result LOINC39111-0
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570190
Result Code NameClient Specimen ID
UofM
Result LOINCN/A
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570191
Result Code NameSpecimen(s) Received
UofM
Result LOINC31208-2
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570192
Result Code NameClinical Data
UofM
Result LOINC55752-0
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570193
Result Code NameResults:
UofM
Result LOINC62365-2
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570194
Result Code NameInterpretation
UofM
Result LOINC62365-2
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570195
Result Code NameAnalytical Results
UofM
Result LOINC21702-6
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570196
Result Code NameComments
UofM
Result LOINC77202-0
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570197
Result Code NameMethodology:
UofM
Result LOINC49549-9
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570198
Result Code NameReferences:
UofM
Result LOINC75608-0
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570199
Result Code NameSigned By
UofM
Result LOINC19139-5
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570200
Result Code NameDisclaimers
UofM
Result LOINCN/A
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570201
Result Code NamePDF
UofM
Result LOINC11502-2
Order Code570186
Order Code NameEGFR Mutation Analysis, NSCLC
Order Loinc
Result Code570202
Result Code NameBill Code Entry Hold
UofM
Result LOINCN/A
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057186 EGFR Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057186
Order NameEGFR Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057186 EGFR Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057186
Order NameEGFR Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057186 EGFR Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057186
Order NameEGFR Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057186 EGFR Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057186
Order NameEGFR Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057186 EGFR Mutation Analysis (B) 000000 Results Pending
Reflex 1
Order Code057186
Order NameEGFR Mutation Analysis (B)
Result Code000000
Result NameResults
UofM
Result LOINCPending
Reflex Table for Results:
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 057186 EGFR Mutation Analysis (B) 000000 PDF 11526-1
Reflex 1
Order Code057186
Order NameEGFR Mutation Analysis (B)
Result Code000000
Result NamePDF
UofM
Result LOINC11526-1