Colorectal Cancer Mutation Panel (KRAS, PIK3CA, BRAF, NRAS)
Test Summary
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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue
8 unstained charged (+) slides
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.
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.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 5 years
- Refrigerated: 5 years
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
N/A
Order Code
COLREC
EPIC (Premier) Code
LAB6515
Includes
KRAS Mutation Analysis, PIK3CA Mutation Analysis, BRAF Mutation Analysis, NRAS Mutation Analysis
CPT Code
- 81275
- 81276
- 81210
- 81309
- 81311
Billing Code
- 670391
CPT Statement
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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
| KRAS Mutation Analysis | Not detected |
| PIK3CA Mutation Analysis | Not detected |
| BRAF Mutation Analysis | Not detected |
| NRAS Mutation Analysis | Not detected |
Setup Schedule / Expected Turnaround Time
Monday - Sunday morning; Report available: 7 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue
8 unstained charged (+) slides
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.
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.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 5 years
- Refrigerated: 5 years
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
N/A
Result Information
Methodology
Next Generation Sequencing
Testing Laboratory
N/A
Reference Range
| KRAS Mutation Analysis | Not detected |
| PIK3CA Mutation Analysis | Not detected |
| BRAF Mutation Analysis | Not detected |
| NRAS Mutation Analysis | Not detected |
Setup Schedule / Expected Turnaround Time
Monday - Sunday morning; Report available: 7 days