| 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 |
| 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: | 10 days |
| Methodology: | Next Generation Sequencing |
| Performed: | Molecular Diagnostics Laboratory |
| Synonyms: | BRAF, BRAF Exons 11 and 15 |
| 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. |
| Patient Preparation : | Tumor sample / sample with tumor cells |
| 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. | |