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Colorectal Cancer Mutation Panel (KRAS, PIK3CA, BRAF, NRAS)
Test Code18902
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 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
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.