EGFR Mutation Analysis

Next Generation Sequencing (NGS) · Dermatology

The EGFR Mutation Analysis assay uses next-generation sequencing (NGS) technology to provide an assessment of the EGFR gene for the detection of genetic alterations with select regions of exons 12, 18, 19, 20, and 21 in human genomic DNA isolated from formalin-fixed paraffin-embedded (FFPE) tissue.

Assay Description

Specimen Requirements

•FFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.

Storage and Transport

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature.

Specimen Rejection Criteria

All specimens must be submitted according to the test directory instructions. Before submitting specimen, please carefully review specimen requirements.

Listed below are possible causes for delays in specimen processing or possible specimen rejections or cancellations:

No patient identification on requisition form
No patient identification on specimen container or slides
No referring provider
No account information provided
No test ordered on requisition
No specimen source provided
Inappropriate specimen type
Insufficient volume for analysis
Inappropriate specimen container
Improper specimen transport
Specimen leaked in transport
Specimen submitted in incorrect or expired transport media
Slides broken beyond repair on receipt
Conflict between patient name on specimen and requisition form
Specimen not properly preserved
Sample containing a needle

A representative from Client Services will attempt to contact your office to resolve specimen problems. Additional documentation may be requested from your office to be returned by fax. In the event that resolution is not possible, the specimen may be returned to your office.

Turn Around Time (TAT)

7-10 Days.

CPT Codes*

81235