Test Overview
Test Methodology

Next-Generation Sequencing

Test Usage

Mutations affecting EGFR occur in approximately 10-20% of non-small cell lung cancers (NSCLC). The particular mutation(s) present within neoplastic cells affects the predicted response to specific targeted therapies including EGFR-directed treatments. This DNA test is performed by targeted next-generation sequencing (NGS) and will detect EGFR mutations within the sequenced regions of exons 3, 7, 12, 15, and 18-21. Specimens should contain an adequate proportion of neoplastic cells (>20%) in the area to be extracted to ensure mutation detection.

Reference Range *

Interpretive Report Provided

Test Limitations

This test does not detect copy number variants or translocations and may not detect large insertions, deletions or duplications. This test may also fail to detect mutations below the limit of detection of this assay (approximately 5%). Rare polymorphisms may lead to false negative results. Discordant results are rarely observed between metastatic and primary specimens. The clinical implications of the findings as indicated in the test report may change based on evolution of the scientific literature.
This test is for the purpose of detecting somatic mutations in neoplastic tissue. While this test cannot definitively distinguish between somatic and germline variants, know germline variants within the targeted regions will not be reported. Alternative testing is required if there is concern for a clinically relevant germline alteration.

Test Details
Days Set Up
Monday – Friday
Analytic Time

5-12 days

Soft Order Code
MiChart Code
EGFR Sequencing by NGS
Molecular Diagnostics
Molecular Diagnostics
Specimen Requirements
Collection Instructions

For formalin-fixed, paraffin-embedded tissue, a block containing an area with a high percentage of neoplastic cells (for micro-/macro-dissection) is preferred. Unstained, UNBAKED slides (5-8, 10-micron slides; 10-15 if few neoplastic cells are present) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature. A Diff-Quik or Papanicolaou stained aspirate smear (preferable containing a high percentage and overall amount of neoplastic cells) is also acceptable. Store at room temperature.

Alternate Specimen
For exhausted formalin-fixed, paraffin-embedded blocks, the original Hematoxylin and Eosin stained slide(s) may be extracted at the discretion of the Molecular Diagnostics Laboratory Director. The extraction process will result in destruction of the slide(s). A digital image of the slide(s) must be collected prior to extraction and retained for a minimum of 10 years from the specimen collection date.
Previously extracted DNA may be accepted; however, the extracting laboratory must take responsibility for ensuring that viable, neoplastic cells comprise at least 20% of cellularity within the extracted sample.
Normal Volume
Formalin-fixed, paraffin-embedded tissue; Diff-Quik stained aspirate smear, Papanicolaou stained aspirate smear. Extracted DNA is also acceptable if extracted in a CLIA certified laboratory.
Additional Information

By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes microdissection billed as a separate additional charge. Test includes pathologist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

CPT Code
81235, 88381-TC
Fee Code
21660, NA037
Pro Fee CPT
G0452-26, 88381-26
NY State Approved