EGFR Mutation Analysis
Table of Contents
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.
•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)