There are key genes that are recurrently mutated in various human cancers. Genomic DNA is isolated from bone marrow, aspirates, peripheral blood or formalin fixed paraffin embedded tissue and the DNA sequence of targeted regions of the ABL1, ABL2, AKT1, AKT2, AKT3, ALK, APC, AR, ARAF, ARHGEF1, ARID1A, ARID2, ASXL1, ATM, ATRX, AXL, B2M, BAP1, BCL2, BCL2L11, BCL6, BCOR, BIRC3, BRAF, BRCA1, BRCA2, BTK, CALR, CARD11, CBL, CCND1, CCND2, CCND3, CCNE1, CD274, CD33, CD79A, CD79B, CDH1, CDK2, CDK4, CDK6, CDKN1B, CDKN2A, CDKN2B, CEBPA, CHD1, CHEK2, CIC, CIITA, CREBBP, CRLF2, CSF1R, CSF3R, CTCF, CTNNB1, CXCR4, DAXX, DDR2, DDX3X, DDX41, DIS3, DNMT3A, EBF1, EGFR, EGR1, EIF1AX, EP300, EPCAM, EPHA2, EPOR, ERBB2, ERBB3, ERBB4, ESR1, ETNK1, ETV6, EWSR1, EZH2, FAM46C, FAS, FAT1, FBXW7, FGF19, FGFR1, FGFR2, FGFR3, FLT1, FOXO1, FUBP1, GAB2, GATA2, GATA3, GNA11, GNA13, GNAI2, GNAQ, GNAS, GNB1, H3F3A, HIF1A, HIST1H1E, HNF1A, HRAS, ID3, IDH1, IDH2, IGF1R, IKBKB, IKZF1, IKZF3, IRAK4, ITPKB, JAK1, JAK2, JAK3, KDR, KEAP1, KIT, KLF2, KRAS, MALT1, MAP2K1, MAP2K2, MAP2K4, MAP3K1, MAP3K14, MAP3K9, MAPK1, MCL1, MDM2, MDM4, MED12, MEF2B, MET, MITF, MLH1, KMT2D, MPL, MSH2, MSH6, MTOR, MYC, MYCN, MYD88, NF1, NF2, NFKBIE, NOTCH1, NOTCH2, NOTCH3, NPM1, NRAS, NT5C2, NTRK1, NTRK2, NTRK3, P2RY8, PALB2, PBRM1, PDGFRA, PDGFRB, PHF6, PIK3CA, PIK3CD, PIK3R1, PIM1, PLCG1, PLCG2, PMS2, POLE, POT1, PPM1D, PRDM1, PRPS1, PTCH1, PTEN, PTPN11, RAC1, RAD21, RB1, REL, RET, RHEB, RHOA, RICTOR, RIPK1, RIT1, RNF43, ROS1, RPS15, RUNX1, S1PR2, SAMHD1, SETBP1, SETD2, SF3B1, SGK1, SH2B3, SMAD4, SMARCB1, SMC1A, SMC3, SMO, SOCS1, SOX2, SPEN, SPOP, SRSF2, STAG2, STAT3, STAT5B, STAT6, STK11, TBL1XR1, TCF3, TERT, TET2, TGFBR1, TGFBR2, TLR2, TNFAIP3, TNFRSF14, TP53, TRAF2, TRAF3, TSC1, TSC2, U2AF1, UBR5, VHL, WT1, XPO1, ZFHX4, ZMYM3, and ZRSR2 genes is determined using next-generation sequencing (NGS) technology.
NexCourse® is a registered trademark of Genoptix, Inc.

disease state indication(s)
Various solid and hematological neoplasms

clinical use
Predictive, prognostic
NexCourse Complete is a multi-gene molecular profiling assay covering genes implicated in the pathogenesis of solid and/or hematological malignancies. The results may provide insight into the pathobiology of the malignancy, aid in risk assessment, and identify potential therapeutic options and clinical trials based on molecular drivers.

methodology/product platform
Capture-based, next generation sequencing (NGS)

specimen type and requirements
Peripheral blood: 2-3 mL in EDTA (purple-top) tube. Bone marrow: 2-3 mL in EDTA (purple-top) tube.
Tissue, Preferred: Two (2) formalin-fixed, paraffin-embedded tissue/fine needle aspirate (FFPE/FNA) blocks containing tumor tissue from recent surgery or biopsy or sixteen (16) 2x5 µm sections with accompanying H&E slide.
Tissue, Acceptable Alternative: One (1) formalin-fixed, paraffin-embedded tissue/fine needle aspirate (FFPE/FNA) block containing tumor tissue from recent surgery or biopsy or eight (8) 2×5 µm sections with accompanying H&E slide.
Unacceptable: Specimens preserved in alternative (non-formalin) fixatives, decalcified specimens, fresh or frozen tissue.
Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE.

turnaround time
Global (TC & PC): 12 days

cpt code(s)
81455 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)