EGFR Mutation Analysis by PCR

Message
Bi-directional sequencing of exons 18-21 of the EGFR gene for detection of EGFR-activating mutations and TKI resistance mutations (including T790M) in these exons. Tumor enrichment is performed before extraction. Testing is approved for specimens from the state of New York.
 


Test Code
LAB6612


Alias/See Also
EGFRvIII, epidermal growth factor receptor


CPT Codes
81235x1

Preferred Specimen
  • FFPE solid tumor 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.
  • Fine needle aspirate (FNA): Requisition must note specimen is FNA. FFPE cell blocks are acceptable if pathologist attaches note verifying sample has >30% tumor or abnormal cells (required). Minimum 10^6 cells.


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


Methodology
Molecular

Report Available
7 days


Clinical Significance
EGFR mutation analysis is recommended in non-small cell lung carcinoma (NSCLC) to detect mutations (commonly L858R and exon 19 deletions) associated with increased sensitivity to EGFR tyrosine kinase inhibitors. Detection of TKI resistance mutations such as T790M in patients being treated with a TKI is useful for planning alternate treatment.


Performing Laboratory
Neogenomics Laboratories



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.