KRAS Mutation Analysis : 16510

Test Code
KRASMA or 16510

Alias/See Also
 KRAS G12, KRAS G12C, G12, G12C

CPT Codes
81275, 81276

Preferred: Formalin-fixed paraffin embedded tissue block.

Alternate: Lavender EDTA or Sodium heparin whole blood or bone marrow.

Transport Container
Preferred: Transport paraffin block: provide tissue source and pathology report.

Alternate: Cut one 3-5 um tissue section for H&E stain (or provide stained H&E slide). Cut 8 (Minimum 4) slides 10 um sections on charged (+) slides. The slide should not be baked or melted. Provide pathology report.
Alternate: 5 mL (Minimum 3 mL) whole blood  OR 3 mL (Minimum 1 mL) bone marrow in EDTA (lavender-top) tube or Sodium heparin (green-top) tube; transport immediately to maintain stability.

Transport Temperature

Specimen Stability
Formalin-fixed Paraffin embedded tissue/unstained slides: Room temperature:  5 years; Refrigerated:  5 years; Frozen: Unacceptable

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

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received frozen.

Polymerase Chain Reaction Sequencing

Setup Schedule
Sunday - Saturday

Report Available
5 days (From receipt at performing laboratory)

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.

Reference Range
Not detected

Clinical Significance
Activating KRAS mutations can be found in human malignancies with an overall frequency of 15-20%, including 25-35% of lung adenocarcinomas, 60-90% of malignant tumors of the pancreas, 30-45% of colorectal carcinomas, and 18-30% of hematopoietic neoplasms of myeloid origin. KRAS proteins have been shown to influence proliferation, differentiation, transformation, and apoptosis by relaying mitogenic and growth signals into the cytoplasm and the nucleus. Mutations leading to an amino acid substitution at positions 12, 13, 61 and 146 of KRAS are the most common in naturally occurring neoplasms. The presence of KRAS mutation in most tumor types is associated with adverse prognosis as well as resistance to receptor tyrosine kinase-directed targeted therapies, including against EGFR.

Please note: KRAS, along with others, is an emerging biomarkers in NSCLC (non-small cell lung cancer) and other tumor types. Currently, in NSCLC the KRAS G12C mutation is prevalent in approximately 13% of patients and represents nearly half (44%) of all KRAS mutations. Investigational agents targeting KRAS G12C are currently in clinical trials.

Performing Laboratory
Quest Diagnostics

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.