Veripath Test Directory

Epic Test Name Cancer Mutation 50-Gene Panel, Next Generation Sequencing
Components
Synonyms Comprehensive Cancer Mutation Panel; NextGen Cancer Panel; 50-Gene Cancer Mutation; Solid Organ Cancer 50-Gene Panel; Leukemia/Lymphoma 50-Gene Panel.
Description Pan-cancer (solid, hematologic) assay for key mutations in ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAS, GNAQ, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, and VHL. Note: Copy number alterations (eg, gene amplification) and translocations are not detected by this assay.
Specimen Requirements 
Container
Specimen Type Formalin-fixed paraffin-embedded (FFPE) tissue, FNA in RPMI, blood, bone marrow, flow cytometry specimen; corresponding pathologist report.
Preferred Collection Volume
Minimum Collection Volume
Collection Instructions FFPE unstained slides: 20 unstained slides, each 10micron thick, total >5.0 microgram of tumor; corresponding H&E required; FNA cell blocks should have >20% tumor cells; no mercury-based (B-5) fixation or decalcification solution.
FNA: RPMI medium or saline, received within 2 hrs of collection if room temperature, thereafter refrigerated, never frozen; tumor cells must constitute >20% of the cells.
Whole Blood: non-heparinized blood; tumor cells must constitute >20% of the cells in the fluid .
Bone marrow: received within 4 hrs of draw if room temperature, thereafter refrigerated, never frozen; decalcified bone marrow cores not acceptable.
Flow cytometry cells: buffered media, non-lysed; received within 3 hrs of collection if room temp, thereafter refrigerated, never frozen; >50,000 tumor cells required.
Specimen Handling
Rejection Criteria Mercury-based fixative (B-5) or decalcified specimens; FFPE cases without corresponding H&E section; FNA or solid tissue received in water; heparinized specimens; frozen FNA or cultured cells.
Methodology Ion Torrent PGM, Next Generation Sequencing.
Reference Range No Mutation Detected
CPT Code(s) 81445 (solid) or 81450 (hematologic), 88381.
Department Molecular Diagnostics
Contact Information Molecular Diagnostics Lab: (214) 648-0960, Toll Free 877-887-8136.
Turn Around TimeInternal Cases: <21 days from order or biopsy date, whichever is later; External Cases: <21 days from order date or receipt of unstained slides, whichever is later.
Performed As requested.
Performed by Molecular Diagnostics
Link
Notes Not orderable as single genes
Updated/Reviewed 03/13/2017


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