| KRAS/BRAF/NRAS Mutations by NGS (AmpliSeq Focus Panel) (LAB002380 (8000101709)) | |
|---|---|
| Test Mnemonic: | KRAS/BRAF/NRAS NGS Panel |
| Specimen Requirements: | |
| Collection: | Resections: 10 unstained 10 micron slides, 1 matching H&E slide. Small Biopsies: 20 unstained 10 micron slides, 1 matching H&E slide. Cell smears: need ≥ 4000 total cells (>20% tumor cells). |
| Container: | Labeled microscope slides with tumor cells. |
| Minimum Volume: | Must have 20% tumor cells in the marked area for mutation analysis. |
| Storage/Transport: | Fixed Tissue: Ambient Non-fixed Tissue: Frozen |
| 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: | |
| Lab: | Molecular Diagnostics Laboratory |
| Synonyms: | KRAS; NRAS; BRAF; Illumina AmpliSeq Focus Panel |
| Clinical Indication: | KRAS: May serve as a companion predicative marker for anti-mutant KRAS treatment. May serve as companion predictive marker for anti-EGFR treatment. May be used for tumor prognosis. BRAF: 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. NRAS: May serve as a companion predicative marker for anti-MEK treatment; May serve as companion predictive marker for anti-EGFR treatment; May be used for tumor prognosis. |
| Patient Preparation : | Tumor sample / sample with tumor cells |
| CPT 4 Code: | 81479 |
| Note: | KRAS, NRAS, and BRAF mutations are examined using next generation sequencing (NGS) with the Illumina AmpliSeq Focus Panel reagent (Illumina, San Diego). This test is used to detect Pathogenic/Likely pathogenic variants in the KRAS and NRAS gene (exons 2-4) and in the BRAF gene (exons 11 and 15). Variants of uncertain significance (VUS), Benign, and Likely benign variants are not reported. |
| 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. | |