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BRAF V600 Mutation Analysis, PCR, Cobas®
Test Code38271
Preferred Specimen
Lavender Top
Minimum Volume
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 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 Container
FFPE: Sterile biohazard plastic bag
Slide: Slide holder
Whole blood and bone marrow: EDTA (lavender-top) tube
Slide: Slide holder
Whole blood and bone marrow: 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
Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination. Do not freeze. Do not reject.
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.
This test is not available for New York patient testing.
Setup Schedule
Thurs
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.
