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Beaumont Laboratory

KRAS Mutation Analysis in Metastatic Colon Cancer and Non-Small Cell Lung Cancer

KRAS, K-RAS, Colon Cancer Mutation Analysis, SOFT GENE: MKRAS, SOFT LAB: MKRSG

Specimen Collection Criteria

Collect: Paraffin-embedded tissue. A paraffin block must be submitted. (Slides or paraffin shavings are not acceptable.) Submit formalin-fixed, paraffin-embedded block with corresponding H&E slide. Tissue should be well fixed and well processed. Average tissue size 5.0 mm2.

  • DNA will be assessed for quality. If it is deemed unacceptable, testing will be cancelled with client notification.
  • The specimen must be accompanied by a completed requisition and must contain the patient name, date of birth, collection date, ordering physician, and source of specimen.  

Physician Office/Drawsite Specimen Preparation

Maintain paraffin-embedded tissue at room temperature (20-26°C or 68-78.8°F) until transport.

Preparation for Courier Transport

Transport: Paraffin-embedded tissue, at room temperature (20-26°C or 68-78.8°F).

Rejection Criteria

  • Decalcified tissue.
  • Fixatives other than 10% neutral buffered formalin.
  • Improper labeling or inadequate information. 


Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): Indefinitely
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Room Temperature (20-26°C or 68-78.8°F): 7 days


Royal Oak Clinical Molecular Pathology Laboratory.


Once per week, usually Wednesday.
Results available in 10 business days.

Reference Range

No KRAS mutations detected OR presence of KRAS mutations is associated with lack of response to anti-EGFR therapy.

Test Methodology

Tissue sections are reviewed by a pathologist and relevent tumor is selected for analysis. DNA is isolated from the sample and quantified. The DNA is amplified using reagents supplied in a KRAS mutation detection kit (a proprietary technology EntroGen, Inc., Tarzana CA). The samples are analyzed using an ABI 7500 FAST Real-Time PCR Instrument (Applied Biosystems Inc, Foster City, CA). False positive or negative results may occur for reasons that include genetic variants or somatic heterogeneity of the tissue sample.


Wild-type, or KRAS mutation present with specific mutation listed (G12R, G12C, G12S, G12V, G12A, G12D, G13D).

Clinical Utility

  • The KRAS Mutation Analysis Assay provides additional guidance in therapeutic treatment decisions for patients with metastatic colorectal adenocarcinoma as well as those with non-small cell lung cancer (NSCLC).
  • Mutations in the KRAS gene, a known downstream signaling molecule in the EGFR signaling pathway, have been described in approximately 15-30% of lung adenocarcinoma and 30-50% of colon adenocarcinoma.
  • Recent studies have found mutations in the KRAS gene to be associated with a poor prognosis. Studies have also found KRAS mutations more frequent in patients who show limited clinical response or develop disease progression with targeted tyrosine kinase inhibitor (TKI) treatments. As a result, determining the KRAS mutational status of a tumor may guide therapeutic decision making for patients with NSCLC or colon adenocarcinoma.

CPT Code


Test Codes


Last Updated


Microtainer® and Vacutainer® are registered trademarks of Becton, Dickinson and Company.
UroVysion® is a registered trademark of Abbott Laboratories. ThinPrep® is a registered trademark of Hologic, Incorporated.

This directory currently reflects information only for specimens collected and/or processed at the Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.