Colorectal Cancer Mutation Panel (KRAS, PIK3CA, BRAF, NRAS)

For Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.

Test Code

CPT Codes
81275, 81276, 81210, 81309, 81311

KRAS Mutation Analysis, PIK3CA Mutation Analysis, BRAF Mutation Analysis, NRAS Mutation Analysis

Preferred Specimen
Formalin-fixed, paraffin-embedded tissue
8 unstained charged (+) slides

Minimum Volume
4 unstained charged (+) slides

Do not reject specimens, send to laboratory for screening.

For submission of paraffin block, tissue source and block ID are required on the requisition form. A pathology report must be submitted.

Shipping samples refrigerated is acceptable; Shipping frozen is unacceptable.

Transport Temperature
Room temperature

Specimen Stability
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable

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
Monday-Sunday Morning
Report available: 7 Days

Reference Range
KRAS Mutation Analysis Not detected
PIK3CA Mutation Analysis Not detected
BRAF Mutation Analysis Not detected
NRAS Mutation Analysis Not detected

Clinical Significance
This panel detecting tumor-associated somatic mutations in 4 different oncogenes can predict response to EGFR-targeted immunotherapy in patients with metastatic colorectal cancer. Tumors with mutations in KRAS, NRAS, BRAF and PI3KCA (exons 9 and 20) are associated with inferior response to anti-EGFR immunotherapy, and variably associated with more aggressive clinical behavior compared to unmutated cases.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

Last Updated: November 29, 2021

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.