| AmpliSeq Focus Solid Tumor Mutation Panel by Next Generation Sequencing (NGS) (LAB002377 (8000101705)) | |
|---|---|
| Test Mnemonic: | Solid Tumor 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 ≥ total 4000 cells (>20% tumor cells). |
| Container: | Labeled microscope slides with tumor cells. |
| Minimum Volume: | Five 10um thick slides with >20% tumor cells in marked area. One H&E-stained slide from the middle of serial sections, circle areas of tumor cells for the test. |
| 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: | No Mutations Identified |
| Turnaround Time: | 10 business days |
| Methodology: | Next Generation Sequencing |
| Performed: | Molecular Diagnostics Laboratory |
| Synonyms: | Solid Tumor Mutations; 47-Gene Solid Tumor Panel |
| Clinical Indication: | In conjunction with clinical findings and other relevant data, this test is used to diagnose malignancy, assess prognosis, or recommend therapy. This test is not designed to detect minimal residual disease. |
| Patient Preparation : | Tumor sample / sample with tumor cells |
| CPT 4 Code: | 81445 (DNA or DNA/RNA analysis) 81449 (RNA analysis only) |
| Note: | Test is performed using Illumina AmpliSeq Focus Panel reagent (Illumina, San Diego). It is a targeted sequencing assay validated to include 47 genes with known relevance to solid tumors. GRCh37 (hg19) reference sequence is used for identifying genetic variants. The assay is validated to detect single-nucleotide variants (SNVs), nucleotide-level insertions and deletions (ie, indels), and RNA fusions of specified genes. The following genes are examined by the assay: DNA – SNVs and indels of genes: AKT1, ALK, AR, BRAF, CDK4, CTNNB1, DDR2, EGFR, ERBB2, ERBB3, ERBB4, ESR1, FGFR2, FGFR3, GNA11, GNAQ, HRAS, IDH1, IDH2, JAK1, JAK2, JAK3, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, PDGFRA, PIK3CA, RAF1, RET, ROS1, SMO RNA fusion drivers: ABL1, ALK, AKT3, AXL, BRAF, EGFR, ERBB2, ERG, ETV1, ETV4, ETV5, FGFR1, FGFR2, FGFR3, MET, NTRK1, NTRK2, NTRK3, PDGFRA, PPARG, RAF1, RET, ROS1 |
| 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. | |