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Test Directory » EGFR Epidermial Growth Factor Receptor (EGFR) Mutation Analysis

Test Directory EGFR Epidermial Growth Factor Receptor (EGFR) Mutation Analysis

EGFR Epidermial Growth Factor Receptor (EGFR) Mutation Analysis

Order Code: EGFRMA

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

N/A

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 macrodissection. 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 sections with H&E stain. Standard volume: 5x10 um sections; 1x4 um sections 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

Do not reject specimens, send to laboratory for screening

Order Code

EGFRMA

EPIC (Premier) Code

LAB4819

Includes

N/A

CPT Code

81235

Billing Code

670269

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