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

Test Code

18902

CPT Codes
81275, 81276, 81210, 81309, 81311

Includes

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

Instructions

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

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

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

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.