KRAS Gene Mutation Analysis, Extended

CPT: 81275; 81276; 88381
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Test Details

Use

KRAS is a guanosine triphosphate (GTP) binding protein involved in downstream receptor signaling, which is critical for cell proliferation, survival, and differentiation. Mutations in the KRAS oncogene are frequently found in human cancers. They are common in pancreatic, colorectal, lung, gallbladder, bile duct, and thyroid cancer. This assay will detect KRAS mutations in exons 2, 3, and 4, allowing the determination of drug response.

Limitations

This assay is able to detect 5% mutation in a background of wild-type DNA.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).

Methodology

SNaPshot Multiplex PCR (primer extension-based method)

Specimen Requirements

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides.

Volume

Formalin-fixed, paraffin-embedded tissue block or four unstained slides and one matching H&E-stained slide at 5 µM.

Minimum Volume

Two unstained slides and one matching H&E-stained slide at 5 μM. Samples with >4 mm² and ≥50% tumor content are preferred.

Container

FFPE tissue blocks or slides.

Storage Instructions

Maintain blocks and slides at room temperature.

Causes for Rejection

Tumor block containing no tumor tissue; broken or stained slides

Clinical Information

Special Instructions

New York state providers: Please contact your client services representative for information about New York state approval. Provide a copy of the pathology report; the KRAS test will be delayed if the pathology report is not received. Direct any questions regarding this test to customer service at 800-345-4363.

References

Bokemeyer C, Van Cutsem E, Rougier P, et al. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: Pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer. 2012 Jul; 48(10):1466-1475. 22446022
Douillard JY, Siena A, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: The PRIME study. J Clin Oncol. 2010 Nov 1; 28(31):4697-4705. 20921465
Karachaliou N, Mayo C, Costa C, et al. KRAS mutations in lung cancer. Clin Lung Cancer. 2013 May; 14(3):205-214. 23122493
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer v2.2015. Fort Washington, Pa: NCCN; 2015.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer v3.2015. Fort Washington, Pa: NCCN; 2015.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Rectal Cancer v2.2015. Fort Washington, Pa: NCCN; 2015.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481075 KRAS Extended Analysis 481061 KRAS Mutation Analysis Result 21702-6
481075 KRAS Extended Analysis 481062 Indications: 42349-1
481075 KRAS Extended Analysis 481063 Specimen Location: N/A
481075 KRAS Extended Analysis 481064 Specimen Type: 31208-2
481075 KRAS Extended Analysis 481066 Block Number: 57723-9
481075 KRAS Extended Analysis 481072 Nucleotide Change: 48004-6
481075 KRAS Extended Analysis 481073 Amino Acid Change: 48005-3
481075 KRAS Extended Analysis 481074 Director Review: 72486-4
481075 KRAS Extended Analysis 481067 Background: 21703-4
481075 KRAS Extended Analysis 481068 Methodology: 49549-9
481075 KRAS Extended Analysis 481071 References: 75608-0
481075 KRAS Extended Analysis 480903 Microdissection Performed 8100-0
481075 KRAS Extended Analysis 481133 Referring Physician 18781-5
481075 KRAS Extended Analysis 481134 Treating Physician 18781-5
481075 KRAS Extended Analysis 481135 Body Site 39111-0
481075 KRAS Extended Analysis 481136 Client Specimen ID N/A
481075 KRAS Extended Analysis 481137 Specimens Received 31208-2
481075 KRAS Extended Analysis 481138 Clinical Data 55752-0
481075 KRAS Extended Analysis 481140 Interpretation 62365-2
481075 KRAS Extended Analysis 481141 Analytical Results 21702-6
481075 KRAS Extended Analysis 481142 Comments 77202-0
481075 KRAS Extended Analysis 481143 Signed By 19139-5
481075 KRAS Extended Analysis 481144 Disclaimers N/A
481075 KRAS Extended Analysis 481145 PDF 51969-4

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