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BRAF Mutation Detection (8000100688)
Test Mnemonic:

BRAF

Specimen Requirements:
Collection:

Formalin fixed (10 percent neutral buffered formalin) and paraffin embedded tissue sections (prepared in Surgical Pathology).  Transport 5 unstained 5-10 micron slides (Minimum is 3 slides depending on the size of the tumor) with a matching HE slide marked tumor area. Tumor cell smear/cell block (prepared in Cytopathology) or blood samples may be used when there are enough tumor cells in the sample.

Container:

Labeled microscope slides with tumor cells for analysis

Minimum Volume:

Need to have 20% tumor cells in the marked area for mutation analysis

Storage/Transport:

Protect specimens from excessive heat. Ship in cooled container during summer months. Transport at room temperature or refrigerated

Specimen Preparation:

Slides are prepared by Surgical Pathology or Cytopathology

Causes for Rejection:

Specimens with less than 20% tumor cells. Incomplete and/or incorrect specimen identification.

Reference Range:

Not detected

Turnaround Time:

7-10 days

Methodology:

PCR, pyrosequencing

Performed:

Molecular Diagnostics Laboratory

Clinical Indication:

 Detection of BRAF Codon 600 Mutations

Patient Preparation :

Tumor sample

CPT 4 Code:

81210

Note:

May serve as a companion predicative marker for anti-mutant BRAF treatment; May serve as companion predictive marker for anti-EGFR treatment - reflex when KRAS is negative; May be used for tumor classification and prognosis

When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.
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