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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 and H&E stain. If an H&E stained slide is sent, then only 5 USS are needed on 4 micron sections or
5 mL peripheral blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube
5 slides and 1 H&E slide submit unstained slides, 5 for testing, and 1 for and H&E stain. If an H&E stained slide is sent, then only 5 USS are needed on 4 micron sections or
5 mL peripheral blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube
Minimum Volume
5 slides and H&E slide: 5 slides and 1 H&E slide
Tissue block and Slide: 1 block and 1 slide
Bone marrow/Peripheral blood: 1 mL
Tissue block and Slide: 1 block and 1 slide
Bone marrow/Peripheral blood: 1 mL
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 stained slide is sent, then only 5 USS are needed on 4 micron sections. At least 10-20% tumor tissue required form most recent biopsy.
Collect Peripheral Blood in a lavender top tube (EDTA) or Bone Marrow in a lavender top tube (EDTA).
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 stained slide is sent, then only 5 USS are needed on 4 micron sections. At least 10-20% tumor tissue required form most recent biopsy.
Collect Peripheral Blood in a lavender top tube (EDTA) or Bone Marrow in a lavender top tube (EDTA).
Transport Temperature
Slides: Room temperature
Blood/bone marrow: Refrigerated (cold packs)
Paraffin embedded Tissue: Room temperature (or Refrigerated [cold packs] in summer)
Blood/bone marrow: Refrigerated (cold packs)
Paraffin embedded Tissue: Room temperature (or Refrigerated [cold packs] in summer)
Specimen Stability
Peripheral blood/Bone marrow
Room temperature: 24 hours
Refrigerated: 5 days
Frozen: Unacceptable
Tissue and Slides
Room temperature: Acceptable
Refrigerated: Preferred
Frozen: Unacceptable
Room temperature: 24 hours
Refrigerated: 5 days
Frozen: Unacceptable
Tissue and Slides
Room temperature: Acceptable
Refrigerated: Preferred
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen
Methodology
Real-Time Qualitative Polymerase Chain Reaction
FDA Status
This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
Setup Schedule
Set up: Thurs; Report available: 2-9 days
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.
