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NRAS Gene Mutation Analysis, Extended

CPT 81311; 88381

Test Details

Cancer Type

Colorectal cancer (CRC), Melanoma, Skin, Thyroid

Technology Used

Molecular

Turnaround Time

5 - 7 days

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.

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.

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

Information on collection, storage, and volume

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