Alternative Name
Discovery Profile
Methodology
Molecular
Test Description

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. If Pan-TRK IHC is expressed or equivocal, NTRK NGS Fusion Profile for NTRK1 fusions, NTRK2 fusions, and NTRK3 fusions will be added by reflex.

  • FISH (9 FISH): ALK, BRAF, HER2, MET, MYC, PDGFRA amplifications, PTEN, RET, ROS1 (tech-only available)

  • IHC (2 biomarkers): PD-L1 22C3 (or for breast tissue: PD-L1 SP142 FDA (TECENTRIQ®) for TNBC), Pan-TRK (tech-only available for PD-L1)

  • NGS (323 genes + 2 biomarkers): ABL1, ABL2, ACVR1B, 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, C11orf30 (EMSY), CARD11, CBFB, CBL, CCND1, CCND2, CCND3, 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, EP300, EPCAM, EPHA3, EPHA5, EPHA7, EPHB1, ERBB2, ERBB3, ERBB4, ERG, ERRFI1, ESR1, EZH2, FAM46C (TENT5C), 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, GPR124 (ADGRA2), GRIN2A, GRM3, GSK3B, H3F3A (H3-3A), HGF, HIST1H3C (H3C3), HNF1A, HRAS, HSD3B1, HSP90AA1, 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, LMO1, LRP1B, LYN, LZTR1, MAGI2, MAP2K1, MAP2K2, MAP2K4, MAP3K1, MCL1, MDM2, MDM4, MED12, MEF2B, MEN1, MET, Microsatellite Instability (MSI), MITF, MLH1, MPL, MRE11A (MRE11), 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, PARK2 (PRKN), PAX5, PBRM1, PDCD1LG2, PDGFRA, PDGFRB, PDK1, PIK3C2B, PIK3CA, PIK3CB, PIK3CG, PIK3R1, PIK3R2, PLCG2, PMS2, POLD1, POLE, PPP2R1A, PRDM1, PREX2, PRKAR1A, PRKCI, PRKDC, 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, TERC, TERT promoter and coding sequence, TET2, TGFBR2, TNFAIP3, TNFRSF14, TOP1, TOP2A, TP53, TSC1, TSC2, TSHR, U2AF1, VEGFA, VHL, WISP3 (CCN6), WT1, XPO1, ZBTB2, ZNF217, ZNF703, Tumor Mutation Burden (TMB)

Clinical Significance

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.

Specimen Requirements

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

Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. All slides can be packed at room temperature.

CPT Code(s)*
81455x1, 88374x1, 88377x8; 88360x1, 88342x1; add 81479x1 if reflexed to NTRK NGS Fusion Profile
Turnaround Time

22 days; add 1-3 days if reflexed to NTRK NGS Fusion Profile

Level of Service
Global

*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.