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BRAF V600 Mutation Analysis, PCR, Cobas®
Test Code38271
CPT Codes
81210<br><strong>This test is not available for New York patient testing.</strong>
Preferred Specimen
1 block and 1 slide: tissue collected in a paraffin-embedded tissue block accompanied by a circled H&E slide indicating the area to be examined, or
5 slides and 1 H&E slide: submit unstained slides, 5 for testing, and 1 for an H&E stain, or
5 mL peripheral blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube
Minimum Volume
1 mL whole blood • 1 mL bone marrow • 1 block and 1 slide minimum
Instructions
Do not reject, send to lab for testing assessment.
Do not centrifuge.
Paraffin-embedded tissue: Room temperature or on ice pack in summer.
Submit archived tissue. For tissue specimens, please provide most recent pathology report. Tissue accompanied by a circled H&E slide indicating the area to be examined. For unstained slides, 5 for testing, and 1 for an H&E stain. If an H&E stain slide is sent, then only 5 USS are needed on 4 micron sections.
At least 10-20% tumor tissue required from most recent biopsy.
Collect peripheral blood or bone marrow in an EDTA (lavender-top) tube.
Do not centrifuge.
Paraffin-embedded tissue: Room temperature or on ice pack in summer.
Submit archived tissue. For tissue specimens, please provide most recent pathology report. Tissue accompanied by a circled H&E slide indicating the area to be examined. For unstained slides, 5 for testing, and 1 for an H&E stain. If an H&E stain slide is sent, then only 5 USS are needed on 4 micron sections.
At least 10-20% tumor tissue required from most recent biopsy.
Collect peripheral blood or bone marrow in an EDTA (lavender-top) tube.
Transport Temperature
Slides: Room temperature
FFPE, blood or bone marrow: Refrigerated (cold packs)
FFPE, blood or bone marrow: Refrigerated (cold packs)
Specimen Stability
Tissue and slides
Room temperature: Acceptable
Refrigerated: Preferred
Frozen: Unacceptable
Peripheral blood and bone marrow
Room temperature: 24 hours
Refrigerated: 5 days
Frozen: Unacceptable
Room temperature: Acceptable
Refrigerated: Preferred
Frozen: Unacceptable
Peripheral blood and bone marrow
Room temperature: 24 hours
Refrigerated: 5 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen
Methodology
Real-Time Qualitative Polymerase Chain Reaction
Setup Schedule
Set up: Thurs; Report available: 2-9 days
Reference Range
Not detected
Clinical Significance
Mutations in BRAF codon 600, including V600E, have been identified in a number of cancers, including colorectal, papillary thyroid carcinoma (PTC), melanoma, a small subset of lung cancers, and hairy cell leukemia. Assessing BRAF mutation status in colorectal cancer may be useful to differentiate sporadic cancer from Lynch syndrome, as a predictor of responsiveness to anti-EGFR therapy, or as a prognostic indicator. BRAF mutation testing may aid in the sub-classification of certain cancers such as melanoma and PTC and may predict responsiveness to BRAF inhibitor therapy in melanoma and non-small-cell lung cancer.
