KRAS Mutation Analysis

KRAS Mutation Analysis

Test Code

16510
81275, 81276
CPT coding may differ dependent on payer rules which may impact prior authorization testing.
Please direct any questions regarding CPT coding to the payer being billed.
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
16510
81275, 81276
CPT coding may differ dependent on payer rules which may impact prior authorization testing.
Please direct any questions regarding CPT coding to the payer being billed.
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

KRAS Mutation Analysis - 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 ...

Test Details

Methodology

Next Generation Sequencing

Assay Category

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(s)

Not detected

Alternative Name(s)

KRAS G12C,G12C,G12,KRAS G12

LOINC® Codes, Performing Laboratory

Methodology

Next Generation Sequencing
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(s)

Not detected

Alternative Name(s)

KRAS G12C,G12C,G12,KRAS G12

Preferred Specimen(s)

Formalin-fixed, paraffin-embedded tissue block

Alternative Specimen(s)

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

Minimum Volume

3 mL whole blood • 1 mL bone marrow aspirate • 4 unstained charged (+) slides

Collection Instructions

Submission of formalin-fixed, paraffin-embedded tissue is the preferred sample type. Other sample types listed are acceptable for testing. For submission of paraffin block, another preferred specimen type, tissue source and block ID are required on the requisition form. A pathology report must be submitted.

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

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

Do not reject specimens. Send to laboratory for screening.

Transport Container

Formalin-fixed, paraffin-embedded tissue block

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

Setup Schedule

Formalin-fixed, paraffin-embedded tissue block
5 mL whole blood collected in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 3 mL bone marrow aspirate submitted in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 8 unstained charged (+) slides
3 mL whole blood • 1 mL bone marrow aspirate • 4 unstained charged (+) slides

Submission of formalin-fixed, paraffin-embedded tissue is the preferred sample type. Other sample types listed are acceptable for testing. For submission of paraffin block, another preferred specimen type, tissue source and block ID are required on the requisition form. A pathology report must be submitted.

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

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

Do not reject specimens. Send to laboratory for screening.

Formalin-fixed, paraffin-embedded tissue block
Room temperature
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
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

The tests listed by specialty and category are a select group of tests offered. For a complete list of Quest Diagnostics tests, please adjust the filter options chosen, or refer to our Directory of Services.