BRAF V600 Mutation Analysis, PCR, Cobas®

Test Code

38271

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 block and 1 slide • 5 slides and 1 H&E slide • 1 mL peripheral blood • 1 mL bone marrow

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.

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 from most recent biopsy.

Or collect peripheral blood or bone marrow in an EDTA (lavender-top) tube.

Transport Temperature

Slides: Room temperature
Paraffin-embedded tissue, 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

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.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.