Days Set Up
Monday - Thursday
Analytic Time

5-12 days

MiChart Code
KRAS Mutation in Malignancy
Soft Order Code

Test Updated:


K-RAS Mutation Detection
KRAS Mutation Detection

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Test Overview

Test Methodology

Next-Generation Sequencing

Test Usage

Activating mutations in the KRAS gene occur in approximately 40% of colorectal carcinomas, 20% of non-small cell lung cancers, and a variety of other human cancers. Mutations are predominantly single nucleotide substitutions (missense mutations), most frequently occurring within codons 12 and 13 of exon 2. Less commonly, mutations occur within codon 61 of exon 3 and codons 117 and 146 of exon 4. Collectively these mutations have been associated with a limited clinical response to epidermal growth factor receptor (EGFR) targeted therapies in lung and colorectal cancers, and may also have prognostic implications. This DNA test is performed by targeted next-generation sequencing to detect mutations within sequenced regions of KRAS exons 2, 3, and 4 (NM_33360.3; Hg19 chr12:25398205-25398304, chr12:25380261-25380349, chr12:25378550-25378658) including codons 12, 13, 61, 117, and 146. 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.

* 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. 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.

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.
Minimum Volume

Billing Information

CPT Code
81275, 81276, 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.