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Alphabetical Index
BRAF Exons 11 and 15 Mutation by Next Generation Sequencing (NGS) (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.
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
Causes for Rejection:

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

Slides are prepared by Surgical Pathology or Cytopathology
Methodology:

Next Generation Sequencing
Performed:

Molecular Diagnostics Laboratory
Turnaround Time:

10 days
Reference Range:

Not detected
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
Synonyms:

BRAF, BRAF Exons 11 and 15
Patient Preparation :

Tumor sample / sample with tumor cells
Clinical Indication:

May serve as a companion predicative marker for anti-mutant BRAF/anti-MEK treatment; May serve as companion predictive marker for anti-EGFR treatment; May be used for tumor classification (eg MSI-H CRC and papillary thyroid cancer); May be used for tumor prognosis.
Effective Date: 01/11/2024
Reviewed By/Date: Dong, Jianli - 01/25/2019
Approved By/Date: Dong, Jianli - 01/19/2024
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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