NeoTYPE® Discovery Profile for Solid Tumors

The NeoTYPE Discovery Profile analyzes 336 biomarkers through a combination of next-generation sequencing (NGS), FISH, and IHC as listed below. Test orders include summary interpretation of all results to help guide treatment decisions. For non-breast tumors, HER2 (Other) w/ Breast Scoring will be added. For breast tumors, HER2 Breast IHC/FISH can be ordered separately, if clinically indicated. If global HER2 (Other) IHC w/Breast Scoring result is 2+, case will reflex to global HER2 (Other) FISH w/Breast Scoring unless reflex to tech-only FISH or reflex opt-out is requested. If Pan-TRK IHC is expressed or equivocal, reflex to either NTRK NGS Fusion Panel (Default) or NTRK 1-3 FISH Panel will be added. A microsatellite instability (MSI) NGS result of “indeterminate” will create a reflex to MSI by PCR as long as the tumor percentage is ≥20% for colorectal specimens or ≥40% with paired normal tissue available for non-colorectal specimens.

• FISH (8 FISH): ALK, BRAF, MET, MYC, PDGFRA amplifications, PTEN, RET, ROS1 (tech-only available)
• IHC (3 biomarkers): HER2 (Other) w/Breast Scoring (non-breast tumors only), PD-L1 22C3 (breast, lung) or PD-L1 LDT (other), Pan-TRK (tech-only available for HER2 and PD-L1)
• NGS (323 genes + 2 biomarkers): ABL1, ABL2, ACVR1B, ADGRA2 (GPR124), AKT1, AKT2, AKT3, ALK, AMER1, APC, AR, ARAF, ARFRP1, ARID1A, ARID1B, ARID2, ASXL1, ATM, ATR, ATRX, AURKA, AURKB, AXIN1, AXL, BAP1, BARD1, BCL2, BCL2L1, BCL2L2, BCL6, BCOR, BCORL1, BLM, BRAF, BRCA1, BRCA2, BRD4, BRIP1, BTG1, BTK, CARD11, CBFB, CBL, CCND1, CCND2, CCND3, CCN6 (WISP3), CCNE1, CD274, CD79A, CD79B, CDC73, CDH1, CDK12, CDK4, CDK6, CDK8, CDKN1A, CDKN1B, CDKN2A, CDKN2B, CDKN2C, CEBPA, CHD2, CHD4, CHEK1, CHEK2, CIC, CREBBP, CRKL, CRLF2, CSF1R, CTCF, CTNNA1, CTNNB1, CUL3, CXCR4, CYLD, DAXX, DDR2, DICER1, DNMT3A, DOT1L, EGFR, EMSY (C11orf30), EP300, EPCAM, EPHA3, EPHA5, EPHA7, EPHB1, ERBB2, ERBB3, ERBB4, ERG, ERRFI1, ESR1, EZH2, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, FAS, FAT1, FBXW7, FGF10, FGF14, FGF19, FGF23, FGF3, FGF4, FGF6, FGFR1, FGFR2, FGFR3, FGFR4, FH, FLCN, FLT1, FLT3, FLT4, FOXL2, FOXP1, FRS2, FUBP1, GABRA6, GATA1, GATA2, GATA3, GATA4, GATA6, GID4, GLI1, GNA11, GNA13, GNAQ, GNAS, GRIN2A, GRM3, GSK3B, HGF, HNF1A, HRAS, HSD3B1, HSP90AA1, H3-3A (H3F3A), H3C3 (HIST1H3C), IDH1, IDH2, IGF1R, IGF2, IKBKE, IKZF1, IL7R, INHBA, INPP4B, IRF2, IRF4, IRS2, JAK1, JAK2, JAK3, JUN, KAT6A, KDM5A, KDM5C, KDM6A, KDR, KEAP1, KEL, KIT, KLHL6, KMT2A, KMT2C, KMT2D, KRAS (includes G12C mutation), LMO1, LRP1B, LYN, LZTR1, MAGI2, MAP2K1, MAP2K2, MAP2K4, MAP3K1, MCL1, MDM2, MDM4, MED12, MEF2B, MEN1, MET, Microsatellite Instability (MSI), MITF, MLH1, MPL, MRE11 (MRE11A), MSH2, MSH6, MTOR, MUTYH, MYC, MYCL, MYCN, MYD88, NBN, NF1, NF2, NFE2L2, NFKBIA, NKX2-1, NOTCH1, NOTCH2, NOTCH3, NPM1, NRAS, NSD1, NTRK1, NTRK2, NTRK3, NUP93, PAK3, PALB2, PAX5, PBRM1, PDCD1LG2, PDGFRA, PDGFRB, PDK1, PIK3C2B, PIK3CA, PIK3CB, PIK3CG, PIK3R1, PIK3R2, PLCG2, PMS2, POLD1, POLE, PPP2R1A, PRDM1, PREX2, PRKAR1A, PRKCI, PRKDC, PRKN (PARK2), PRSS8, PTCH1, PTEN, PTPN11, QKI, RAC1, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RAF1, RANBP2, RARA, RB1, RBM10, RET, RICTOR, RNF43, ROS1, RPTOR, RUNX1, RUNX1T1, SDHA, SDHB, SDHC, SDHD, SETD2, SF3B1, SLIT2, SMAD2, SMAD3, SMAD4, SMARCA4, SMARCB1, SMO, SNCAIP, SOCS1, SOX10, SOX2, SOX9, SPEN, SPOP, SPTA1, SRC, STAG2, STAT3, STAT4, STK11, SUFU, SYK, TAF1, TBX3, TENT5C (FAM46C), TERC, TERT promoter, TET2, TGFBR2, TNFAIP3, TNFRSF14, TOP1, TOP2A, TP53, TSC1, TSC2, TSHR, U2AF1, VEGFA, VHL, WT1, XPO1, ZBTB2, ZNF217, ZNF703, Tumor Mutation Burden (TMB)