NRAS Mutation Analysis

Test Code
16818


CPT Codes
81311<br />

Preferred Specimen
Formalin fixed paraffin embedded tissue


Minimum Volume
3 mL whole blood • 1 mL bone marrow • 4 slides


Other Acceptable Specimens
5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 8 unstained charged (+) slides


Instructions
Do not reject specimens, send to laboratory for screening. Paraffin block is the preferred sample type. Sample source and block ID are required on the requisition form and a pathology report must be submitted.

Whole blood (acceptable): Follow standard whole blood collection procedures. Collect 3-5 mL whole blood in an EDTA tube. Record sample type, collection time, and date on both tube and requisition form.

Bone marrow (acceptable) collection: The notation of sample type, collection time, and date on the tube and requisition form is required. Ship sample refrigerated or room temperature. Ship immediately to maintain stability.


Transport Temperature
Room temperature


Specimen Stability
Formalin-fixed, paraffin-embedded tissue/slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable

Whole blood and bone marrow
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable


Methodology
Next Generation Sequencing

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

A.M.



Clinical Significance
NRAS mutations have been described in a variety of cancers including 3-5% of colorectal carcinomas, 10-20% of melanomas and 10% of acute myeloid leukemias. Mutations leading to an amino acid substitution at positions 12, 13, 61 and 146 of NRAS are the most common in naturally occurring neoplasms.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.