Days Set Up
Monday - Friday
Analytic Time

3 - 8 days

MiChart Code
EGFR Mutation by Fragment Analysis
Soft Order Code

Test Updated:



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All specimens should be accompanied by a requisition.

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MLabs provides all the supplies necessary for the collection of specimens.

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Test Overview

Test Methodology

Multiplex PCR with capillary electrophoresis detection.

Test Usage

EGFR gene mutations occur in 10-40% of non-small cell lung cancer (NSCLC) cases. The most common mutations include exon 19 deletions and the exon 21 L858R substitution which together comprise ~85% of all EGFR mutations. The presence of either of these mutation types has been associated with clinical response to tyrosine kinase inhibitor therapies (gefitinib and erlotinib). This fragment analysis test will detect EGFR exon 19 deletion mutations and the L858R mutation in formalin fixed paraffin-embedded blocks, unstained paraffin sections on slides, and fresh/frozen tissue. The submitted specimen should contain an adequate proportion of tumor cells (> 5%) to enable mutation detection.

Reference Range

Interpretive report provided

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Specimen Requirements

Collection Offsite

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. Diff-Quik stained aspirate smears (preferable containing a high percentage and overall amount of neoplastic cells) are acceptable. Store at room temperature.

Normal Volume
Formalin-fixed, paraffin-embedded tissue; Diff-Quik stained aspirate smear
Minimum Volume

Billing Information

CPT Code
81235, 88381-TC
Pro Fee Code

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Our High Standard

Quality that sets us apart

As the reference laboratory division of Michigan Medicine's Department of Pathology, MLabs shares the institution's commitment to applying established quality principles to clinical laboratory testing. Like other large organizations in complex, consequential fields, we rely on an established approach to monitor quality throughout the testing process.