NeoTYPE® Discovery Profile for Solid Tumors

  • Next Generation Sequencing (NGS)

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).

Turnaround time
14 Days; add 1-3 Days if reflexed to NTRK NGS Fusion Profile

Level of Service

  • Global
New York Approved: Yes

Specimen Requirements

FFPE tissue: Paraffin block preferred. Please use 10% buffered formalin fixative. Do not use zinc fixatives.

Storage and Transportation

Storage & Transportation: Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.

CPT Code(s)*

81455x1, 88377x8; 88360x2, 88342x1; add 88374x1 if HER2 IHC is reflexed to FISH; add 81479x1 if reflexed to NTRK NGS Fusion Panel (default) or 88374x3 automated (88377x3 manual) if reflexed to NTRK 1-3 FISH Panel

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

Last Updated: January 22, 2025

Get in touch

Our Client Services team is on hand to help. Please call us at 866.776.5907, Option 3.