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

Test Code
COLREC


Alias/See Also
18902


CPT Codes
81275, 81276, 81210, 81309, 81311<br><strong>CPT coding may differ dependent on payer rules which may impact prior authorization testing.</strong><br><strong>Please direct any questions regarding CPT coding to the payer being billed.</strong>

Includes
KRAS Mutation Analysis
PIK3CA Mutation Analysis
BRAF Mutation Analysis
NRAS Mutation Analysis


Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block


Minimum Volume
4 unstained charged (+) slides


Other Acceptable Specimens
8 unstained charged (+) slides


Instructions
For submission of paraffin block, tissue source and block ID are required on the test requisition. A pathology report must be submitted.
Shipping samples refrigerated acceptable. Shipping frozen unacceptable.

Do not reject specimens. Send to Laboratory for screening.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 5 years
Refrigerated: 5 years
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
Set up Daily; Report available: 7 days


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
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130



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.