BRAF V600E/V600K Somatic Mutation Analysis, Tumor
Use
This test is useful for therapy selection in patients with cancer, such as melanomas that may respond to BRAF inhibitors, and colon cancers that may not respond to EGFR inhibitors. It aids in the diagnosis and prognosis of certain cancers like hairy cell leukemia, papillary thyroid cancers, and assesses the risk for Lynch syndrome. The test evaluates tumor DNA for BRAF V600E or V600K mutations, indicating candidate eligibility for targeted therapies. BRAF mutations are indicators of tumor progression and response or resistance to specific therapies.
Special Instructions
A pathology report is required and must accompany the specimen. The report must include patient name, block number on all materials, date of tissue collection, and source of tissue. Unused unstained slides will not be returned. If not ordering electronically, an Oncology Test Request form (T729) must be sent with the specimen.
Limitations
Not all tumors with BRAF mutations respond to targeted therapies. The test is specific for V600E and V600K mutations but not sensitive for other V600 alterations. Results should be interpreted in context of clinical findings and other laboratory data. The assay was developed for formalin-fixed, paraffin-embedded tissues, and other fixatives may affect the results. The test is not validated for serial monitoring or differentiating somatic from germline alterations, and additional testing may be necessary for hereditary risk assessment.
New York Approved
Methodology
PCR-based (ddPCR)
Biomarkers
LOINC Codes
- 97025-1
- 50397-9
- 97025-1
- 69047-9
- 48767-8
- 31208-2
- 18771-6
- 85069-3
- 80398-1
- 62364-5
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
Container
Formalin-fixed, paraffin-embedded tissue block
Collection Instructions
Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.