NRAS Gene Mutation Analysis, Extended

CPT: 81311; 88381 81311; 81479; 88381
Updated on 8/29/2018
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Test Details

Use

NRAS is a guanosine triphosphate (GTP)-binding protein involved in downstream receptor signaling, which is critical for cell proliferation, survival, and differentiation. Mutations in the NRAS oncogene are frequently found in human cancers. They are common in melanomas, colorectal cancer, and thyroid cancer. This assay detects NRAS 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 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 >4mm² and ≥50% tumor content are preferred.

Container

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

Storage Instructions

Maintain blocks/slides at room temperature.

Causes for Rejection

Tumor block containing insufficient tumor tissue; broken or stained slides

Clinical Information

Special Instructions

Provide a copy of the pathology report; the NRAS 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

Bae JS, Choi SK, Jeon S, et al. Impact of NRAS mutations on the diagnosis of follicular neoplasm of thyroid. Int J Endocrinol. 2014:289834. 25254041
Benson AB 3rd, Bekaii-Saab T Chan E, et al. Rectal cancer. J Natl Compr Canc Netw. 2012 Dec 1; 10(12):1528-1564. 23221790
Benson AB 3rd, Venook AP, Bekaii-Saab T, et al. Colon cancer, version 3.2014. J Natl Compr Canc Netw. 2014 Jul; 12(7):1028-1059. 24994923
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 randomized clinical trials. Eur J Cancer. 2012 Jul; 48(10):1466-1475. 22446022
Douillard JY, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with 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
Thumar J, Shahbazian D, Aziz SA, Jilaveanu LB, Kluger HM. MEK targeting in N-RAS mutated metastatic melanoma. Mol Cancer. 2014 Mar 4; 13:45-54. 24588908

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481120 NRAS Extended Analysis 481121 Results: 21719-0
481120 NRAS Extended Analysis 481122 Indications: 42349-1
481120 NRAS Extended Analysis 481123 Specimen Location: N/A
481120 NRAS Extended Analysis 481124 Specimen Type: 31208-2
481120 NRAS Extended Analysis 481125 Block Number: 57723-9
481120 NRAS Extended Analysis 481088 Nucleotide Change: 48004-6
481120 NRAS Extended Analysis 481089 Amino Acid Change: 48005-3
481120 NRAS Extended Analysis 481126 Background: 8251-1
481120 NRAS Extended Analysis 481127 Methodology: 49549-9
481120 NRAS Extended Analysis 481128 References: 75608-0
481120 NRAS Extended Analysis 481131 Director Review: 72486-4
481120 NRAS Extended Analysis 480903 Microdissection Performed 8100-0
481120 NRAS Extended Analysis 481146 Referring Physician 18781-5
481120 NRAS Extended Analysis 481147 Treating Physician 18781-5
481120 NRAS Extended Analysis 481148 Body Site 39111-0
481120 NRAS Extended Analysis 481149 Client Specimen ID N/A
481120 NRAS Extended Analysis 481150 Specimens Received 31208-2
481120 NRAS Extended Analysis 481151 Clinical Data 55752-0
481120 NRAS Extended Analysis 481153 Interpretation 62365-2
481120 NRAS Extended Analysis 481154 Analytical Results 21719-0
481120 NRAS Extended Analysis 481155 Comments 77202-0
481120 NRAS Extended Analysis 481157 Signed By 19139-5
481120 NRAS Extended Analysis 481158 Disclaimers N/A
481120 NRAS Extended Analysis 481159 PDF 51969-4

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The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf