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)
The NeoTYPE Discovery Profile for Solid Tumors combines NGS, FISH and IHC to allow for the accurate and sensitive detection of genomic alterations in the genes most relevant to various solid tumor cancers. These genomic alterations include SNP's, indels, rearrangements and other alterations. Testing can aid in the diagnosis of various diseases and provide information to develop strategies for the treatment and management of the underlying disease. In addition, the results obtained from the NeoTYPE Discovery Profile for Solid Tumors can also be used in current or future clinical research projects.
- FFPE tissue: Paraffin block preferred. Please use 10% buffered formalin fixative. Do not use zinc fixatives.
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. All slides can be packed at room temperature.
14 days; add 1-3 days if reflexed to NTRK NGS Fusion Profile