Lab Test

Test Definition Number : 25
Test Definition Name : EGFR sequence analysis
Lab Name : OHSU Knight Diagnostics Lab
Lab Test Number of THIS Version : 1180
Lab Test Name : EGFR Mutation Analysis
Status : Active
Expired : No
Updated : 2018-01-28 07:47 EST

General Attributes

Chromosome Band : 7p11.2
HUGO Gene Name : [EGFR] epidermal growth factor receptor
ICD-Oncology Code
(includes WHO classification diagnoses)
:

Infectious Disease Attributes

Agent Category :
Non-virus Genus and Species :
Virus Family, Genus, and Species :

Lab-specific Attributes

Method : Polymerase Chain Reaction (PCR) - Real Time
Sequencing - Pyrosequencing
Sequencing - Sanger - Bi-directional
Specimen Source
(for clinical patient care these sources must be validated)
: Solid Tissue Paraffin-Embedded Formalin-Fixed
ICD-10 Code :
Use : Clinical - CLIA-certified lab
Genetics Category : Acquired (somatic)
SNOMED CT :
LOINC :
Comments : Background: Activating mutations in EGFR are present in approximately 10-12% of non-small cell carcinomas of the lung (primarily adenocarcinomas). Based on a number of phase II and III trials, most EGFR mutations predict a good response to treatment with EGFR inhibitors such as gefitinib and erlotinib. The exceptions are insertion mutations in exon 20 and the T790M substitution, which correlate with resistance to these drugs. Methodology: 1. Microscopic examination of the specimen and macrodissection of tumor-rich areas. 2. DNA extraction and purification. 3. PCR amplification of EGFR coding exons 18, 19, 20 & 21. 4. Screening for mutations by one of two methods. a. Pyrosequencing of each exon. b. Real-time PCR with high resolution melting curve analysis (HRM), to screen for deletions in exon 19 and insertions in exon 20. DNA sequencing is used to confirm any potential mutations identified by this approach. 5. Estimated sensitivity: 20% mutant allele. 6. Estimated specificity: 98% of EGFR mutations reported in non-small cell lung carcinoma.
Specimen Transport Requirements : Paraffin block or 10 unstained sections (4-5 micron) Due to DNA damage, decalcified specimens are not recommended. Package and ship samples at room temperature. Ship via overnight express. Contact Client Services at (855) 535-1522 for shipping kits and instructions.
Samples Available for Proficiency Test Sample Exchange : Yes

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