Test Summary
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.
Aliases
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block
Minimum Volume
4 unstained charged (+) slides
Instructions
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
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature:5 years
- Refrigerated: 5 years
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
8 unstained charged (+) slides
Unacceptable Specimens
N/A
Order Code
EGFRMA
EPIC (Premier) Code
LAB4819
Includes
N/A
CPT Code
Billing Code
CPT Statement
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.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Daily; Report available: 7 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block
Minimum Volume
4 unstained charged (+) slides
Instructions
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
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature:5 years
- Refrigerated: 5 years
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
8 unstained charged (+) slides
Unacceptable Specimens
N/A
Billing
CPT Code
Billing Code
CPT Statement
Result Information
Methodology
Next Generation Sequencing
Testing Laboratory
N/A
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Daily; Report available: 7 days
