KRAS Somatic Mutation Analysis, Tumor
Use
This test is useful for detecting molecular markers associated with response or resistance to specific cancer therapies. Monoclonal antibodies against epidermal growth factor receptor (EGFR), such as cetuximab and panitumumab, represent an area of targeted therapy for patients with colorectal and non-small cell lung cancer (NSCLC). However, studies have shown that not all individuals with colorectal cancer or NSCLC respond to EGFR targeted molecules. As altered KRAS constitutively activates the RAS/MAPK pathway downstream of EGFR, agents such as cetuximab and panitumumab, which prevent ligand-binding to EGFR, do not appear to have any meaningful inhibitor activity on cell proliferation in the presence of altered KRAS. Current data suggest that the efficacy of EGFR-targeted therapies in colon cancer and NSCLC is confined to patients with tumors lacking KRAS mutations.
Special Instructions
Not provided.
Limitations
This assay is designed to detect variants in KRAS codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T). It has not been clinically validated for use as a tool to monitor response to therapy or for early detection of tumors. This test cannot differentiate between somatic and germline alterations. Not all patients whose tumors have wildtype KRAS respond to epidermal growth factor receptor (EGFR)-targeted therapies. Rare genetic alterations may lead to false-negative or false-positive results.
Methodology
PCR-based (ddPCR)
Biomarkers
KRAS
Gene
LOINC Codes
- 103955-1 - KRAS Somatic mut analysis Tumor
- 50397-9 - Mol dx interp Bld/T Ql
- 82939-0 - Genetic variant details Bld/T
- 69047-9 - Geneticist review
- 31208-2 - Specimen source
- 80398-1 - Unique ID Current sample
- 18771-6 - Provider signing name
- 85069-3 - Lab test method
- 62364-5 - Test performance info Spec
- 48767-8 - Annotation comment Imp
Result Turnaround Time
6-12 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Submit a formalin-fixed, paraffin-embedded tissue block with an acceptable amount of tumor tissue.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Preferred ambient |
