BRAF V600 Mutation Analysis by PCR : 1015984

For tissue specimens, please provide most recent pathology report.

MDFCPBRAFC or 1015984

V600; BRAF

Submit Archived Tissue.

Or

Collect Peripheral Blood in a lavender top tube (EDTA) or Bone Marrow in a lavender top tube (EDTA).

Submit Paraffin embedded Tissue accompanied by a circled H & E slide indicating the area to be examined. At least 10-20% tumor tissue required form most recent biopsy: submit in sterile biohazard plastic bag. Slides: submit in slide holder. Do not submit decalcified tissue specimen. Include most recent surgical pathology report.

Submit 5 mL Blood (Min. 1 mL) or 3 mL Bone marrow (Min. 1 mL). Do not centrifuge.

Paraffin embedded Tissue: Ambient or on ice pack in summer
Slides: Ambient.
Blood or Bone Marrow: Refrigerated.

Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Blood or Bone Marrow: Ambient: 24 hours; Refrigerated: 5 days; Frozen: Unacceptable

Decalcified tissue specimen.

Thursday

2-9 days

This test is designed to detect the BRAF V600E mutation. It demonstrates partial cross-reactivity to the BRAF V600K, V600D, and V600E “complex” mutations, but does not distinguish these mutations from the V600E mutation. Samples with results reported as “mutation not detected” may harbor BRAF mutations not detectable by the assay. The limit of detection of this assay (the minimum percentage of mutant DNA that can be detected in a background of wild-type) is approximately 4 percent for the BRAF V600E mutation. Additional testing by next generation sequencing methods is available which offers more sensitive detection of the BRAF V600E mutation as well as detection of clinically relevant non-V600E BRAF mutations. Results should be interpreted in conjunction with other clinical and pathological findings.

Mutation not detected in BRAF Codon 600.

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.