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Epidermal Growth Factor Receptor (EGFR) Mutation Analysis
Test Code16460
CPT Codes
81235
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block
Minimum Volume
4 unstained charged (+) slides
Other Acceptable Specimens
8 unstained charged (+) slides
Instructions
Do not reject specimens, send to laboratory for screening.
FFPE tissue block: Regular procedure for paraffin-embedded tissue block preparation.
Slide preparation: Cut one 3-5 microns tissue section for H&E stain. Cut 3-5 (10 microns) sections on charged regular glass slides for microdissection. The slide should not be baked or melted. A new blade must be used for cutting each paraffin block to prevent cross contamination.
Minimum volume: 3x10 um sections; 1x4 um section with H&E stain
Standard volume: 5x10 um sections; 1x4 um section with H&E stain
FFPE tissue block: Regular procedure for paraffin-embedded tissue block preparation.
Slide preparation: Cut one 3-5 microns tissue section for H&E stain. Cut 3-5 (10 microns) sections on charged regular glass slides for microdissection. The slide should not be baked or melted. A new blade must be used for cutting each paraffin block to prevent cross contamination.
Minimum volume: 3x10 um sections; 1x4 um section with H&E stain
Standard volume: 5x10 um sections; 1x4 um section with H&E stain
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Refrigerated: 5 years
Frozen: Unacceptable
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Monday-Sunday Morning
Report available: 7 Days
Report available: 7 Days
Reference Range
| EGFR Mutation | Not detected |
Clinical Significance
EGFR kinase domain mutations are found in 10-15% of lung adenocarcinomas, particularly those occurring in younger patients without a smoking history, and identify tumors that may have significant clinical response to EGFR-targeted kinase inhibitors. PCR-based DNA sequencing is used to assess for mutations in exons 18-21 of EGFR, which are the sites of greater than 95% of somatic mutations observed in tumors. This assay will also detect the T790M mutation, which is commonly seen in acquired resistance.
With this information, physicians will be able to select those patients who are most likely to respond to targeted lung cancer therapy. In addition, follow-up samples from patients with resistant or recurrent disease may demonstrate an acquired T790M mutation, where newer FDA-approved agents have been shown to be effective.
With this information, physicians will be able to select those patients who are most likely to respond to targeted lung cancer therapy. In addition, follow-up samples from patients with resistant or recurrent disease may demonstrate an acquired T790M mutation, where newer FDA-approved agents have been shown to be effective.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153
