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For hours, walk-ins and appointments.Epidermal Growth Factor Receptor (EGFR) Gene Mutation Analysis, Non−Small-cell Lung Cancer (Single-base Extension)
CPT:
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
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.
Expected 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
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 (Note: Samples with >4 mm² and ≥50% tumor content are preferred.)
Container
Slides or blocks
Storage 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
Test Details
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.
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 US Food and Drug Administration (FDA).
Methodology
SNaPshot Multiplex PCR (primer extension-based method)
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.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 489360 | EGFR Mutation Analysis, NSCLC | 489361 | EGFR Result: | 21665-5 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 489365 | Interpretation: | 50398-7 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 489362 | Nucleotide change: | 48004-6 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 489363 | Amino acid change: | 48005-3 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 489437 | Background: | 21666-3 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 489366 | Director Review: | 72486-4 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 489364 | Block Number: | 57723-9 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 480903 | Microdissection Performed | 8100-0 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481184 | Referring Physician | 18781-5 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481185 | Treating Physician | 18781-5 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481186 | Body Site | 39111-0 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481187 | Client Specimen ID | N/A | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481188 | Specimens Received | 31208-2 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481189 | Clinical Data | 55752-0 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481191 | Interpretation | 62365-2 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481192 | Analytical Results | 21665-5 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481193 | Comments | 77202-0 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481464 | Methodology | 49549-9 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481465 | References: | 75608-0 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481194 | Signed By | 19139-5 | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481195 | Disclaimers | N/A | ||
| 489360 | EGFR Mutation Analysis, NSCLC | 481196 | 51969-4 |
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