Neo Comprehensive™ - Solid Tumor is a broad, next-generation sequencing panel for pan-solid tumor indications. The assay detects single nucleotide variants (SNV), insertions/deletions (InDels), copy number variants (CNV), and RNA fusions and splice variants in a total of 517 genes (517 genes analyzed by DNA, 55 genes by RNA), plus microsatellite instability (MSI*) and tumor mutational burden (TMB).
DNA GENE LIST: DETECTION OF SNVs, INDELS AND CNVs
ABL1, ABL2, ACVR1, ACVR1B, AKT1, AKT2*, AKT3, ALK*, ALOX12B, ANKRD11, ANKRD26, APC, AR*, ARAF, ARFRP1, ARID1A, ARID1B, ARID2, ARID5B, ASXL1, ASXL2, ATM*, ATR, ATRX, AURKA, AURKB, AXIN1, AXIN2, AXL, B2M, BAP1, BARD1, BBC3, BCL10, BCL2, BCL2L1, BCL2L11, BCL2L2, BCL6, BCOR, BCORL1, BCR, BIRC3, BLM, BMPR1A, BRAF*, BRCA1*, BRCA2*, BRD4, BRIP1, BTG1, BTK, C11orf30, CALR, CARD11, CASP8, CBFB, CBL, CCND1*, CCND2, CCND3*, CCNE1*, CD274, CD276, CD74, CD79A, CD79B, CDC73, CDH1, CDK12, CDK4*, CDK6*, CDK8*, CDKN1A, CDKN1B, CDKN2A, CDKN2B, CDKN2C, CEBPA, CENPA, CHD2, CHD4, CHEK1*, CHEK2*, CIC, CREBBP, CRKL, CRLF2, CSF1R, CSF3R, CSNK1A1, CTCF, CTLA4, CTNNA1, CTNNB1, CUL3, CUX1, CXCR4, CYLD, DAXX, DCUN1D1, DDR2, DDX41, DHX15, DICER1, DIS3, DNAJB1, DNMT1, DNMT3A, DNMT3B, DOT1L, E2F3, EED, EGFL7, EGFR*, EIF1AX, EIF4A2, EIF4E, EML4, EP300, EPCAM, EPHA3, EPHA5, EPHA7, EPHB1, ERBB2*, ERBB3*, ERBB4, ERCC1*, ERCC2*, ERCC3, ERCC4, ERCC5, ERG, ERRFI1, ESR1*, ETS1, ETV1, ETV4, ETV5, ETV6, EWSR1, EZH2, FAM123B, FAM175A, FAM46C, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FAS, FAT1, FBXW7, FGF1*, FGF10*, FGF14*, FGF19*, FGF2*, FGF23*, FGF3*, FGF4*, FGF5*, FGF6*, FGF7*, FGF8*, FGF9*, FGFR1*, FGFR2*, FGFR3*, FGFR4*, FH, FLCN, FLI1, FLT1, FLT3, FLT4, FOXA1, FOXL2, FOXO1, FOXP1, FRS2, FUBP1, FYN, GABRA6, GATA1, GATA2, GATA3, GATA4, GATA6, GEN1, GID4, GLI1, GNA11, GNA13, GNAQ, GNAS, GPR124, GPS2, GREM1, GRIN2A, GRM3, GSK3B, H3F3A, H3F3B, H3F3C, HGF, HIST1H1C, HIST1H2BD, HIST1H3A, HIST1H3B, HIST1H3C, HIST1H3D, HIST1H3E, HIST1H3F, HIST1H3G, HIST1H3H, HIST1H3I, HIST1H3J, HIST2H3A, HIST2H3C, HIST2H3D, HIST3H3, HNF1A, HNRNPK, HOXB13, HRAS, HSD3B1, HSP90AA1, ICOSLG, ID3, IDH1, IDH2, IFNGR1, IGF1, IGF1R, IGF2, IKBKE, IKZF1, IL10, IL7R, INHA, INHBA, INPP4A, INPP4B, INSR, IRF2, IRF4, IRS1, IRS2, JAK1, JAK2*, JAK3, JUN, KAT6A, KDM5A, KDM5C, KDM6A, KDR, KEAP1, KEL, KIF5B, KIT*, KLF4, KLHL6, KRAS*, LAMP1*, LATS1, LATS2, LMO1, LRP1B, LYN, LZTR1, MAGI2, MALT1, MAP2K1, MAP2K2, MAP2K4, MAP3K1, MAP3K13, MAP3K14, MAP3K4, MAPK1, MAPK3, MAX, MCL1, MDC1, MDM2*, MDM4*, MED12, MEF2B, MEN1, MET*, MGA, MITF, MLH1, MLL, MLLT3, MPL, MRE11A, MSH2, MSH3, MSH6, MST1, MST1R, MTOR, MUTYH, MYB, MYC*, MYCL1*, MYCN*, MYD88, MYOD1, NAB2, NBN, NCOA3, NCOR1, NEGR1, NF1, NF2, NFE2L2, NFKBIA, NKX2-1, NKX3-1, NOTCH1, NOTCH2, NOTCH3, NOTCH4, NPM1, NRAS*, NRG1*, NSD1, NTRK1, NTRK2, NTRK3, NUP93, NUTM1, PAK1, PAK3, PAK7, PALB2, PARK2, PARP1, PAX3, PAX5, PAX7, PAX8, PBRM1, PDCD1, PDCD1LG2, PDGFRA*, PDGFRB*, PDK1, PDPK1, PGR, PHF6, PHOX2B, PIK3C2B, PIK3C2G, PIK3C3, PIK3CA*, PIK3CB*, PIK3CD, PIK3CG, PIK3R1, PIK3R2, PIK3R3, PIM1, PLCG2, PLK2, PMAIP1, PMS1, PMS2, PNRC1, POLD1, POLE, PPARG, PPM1D, PPP2R1A, PPP2R2A, PPP6C, PRDM1, PREX2, PRKAR1A, PRKCI, PRKDC, PRSS8, PTCH1, PTEN*, PTPN11, PTPRD, PTPRS, PTPRT, QKI, RAB35, RAC1, RAD21, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD52, RAD54L, RAF1*, RANBP2, RARA, RASA1, RB1, RBM10, RECQL4, REL, RET*, RFWD2, RHEB, RHOA, RICTOR*, RIT1, RNF43, ROS1, RPS6KA4, RPS6KB1*, RPS6KB2, RPTOR, RUNX1, RUNX1T1, RYBP, SDHA, SDHAF2, SDHB, SDHC, SDHD, SETBP1, SETD2, SF3B1, SH2B3, SH2D1A, SHQ1, SLIT2, SLX4, SMAD2, SMAD3, SMAD4, SMARCA4, SMARCB1, SMARCD1, SMC1A, SMC3, SMO, SNCAIP, SOCS1, SOX10, SOX17, SOX2, SOX9, SPEN, SPOP, SPTA1, SRC, SRSF2, STAG1, STAG2, STAT3, STAT4, STAT5A, STAT5B, STK11, STK40, SUFU, SUZ12, SYK, TAF1, TBX3, TCEB1, TCF3, TCF7L2, TERC, TERT, TET1, TET2, TFE3, TFRC*, TGFBR1, TGFBR2, TMEM127, TMPRSS2, TNFAIP3, TNFRSF14, TOP1, TOP2A, TP53, TP63, TRAF2, TRAF7, TSC1, TSC2, TSHR, U2AF1, VEGFA, VHL, VTCN1, WISP3, WT1, XIAP, XPO1, XRCC2, YAP1, YES1, ZBTB2, ZBTB7A, ZFHX3, ZNF217, ZNF703, ZRSR2
* Denotes genes with CNV detection
RNA GENE LIST: DETECTION OF FUSIONS AND SPLICE VARIANTS
ABL1, AKT3, ALK, AR**, AXL, BCL2, BRAF, BRCA1, BRCA2, CDK4, CSF1R, EGFR**, EML4, ERBB2, ERG, ESR1, ETS1, ETV1, ETV4, ETV5, EWSR1, FGFR1, FGFR2, FGFR3, FGFR4, FLI1, FLT1, FLT3, JAK2, KDR, KIF5B, KIT, MET**, MLL, MLLT3, MSH2, MYC, NOTCH1, NOTCH2, NOTCH3, NRG1, NTRK1, NTRK2, NTRK3, PAX3, PAX7, PDGFRA, PDGFRB, PIK3CA, PPARG, RAF1, RET, ROS1, RPS6KB1, TMPRSS2
** Denotes genes with splice variants including AR-V7, EGFRvIII, and MET exon 14 skipping.
IMMUNOTHERAPY MARKERS
MSI, TMB
MSI-high is defined as ≥20% of loci showing instability; microsatellite-stable (MSS) is defined as <20% of loci showing instability.*
Tumor Mutational Burden (TMB):
- TMB-high is defined as ≥10.0 mut/Mb (mutations per megabase)
- TMB-low is defined as <10.0 mut/Mb
*Samples exhibiting instability in >= 20% of microsatellites are reported as MSI-High. Samples below the 20% threshold are reported as MSI-Stable, except for endometrial tumors, which are reported as MSI-indeterminate. Additional confirmation test can be ordered to evaluate MSI-indeterminate results.
Neo Comprehensive - Solid Tumor detects genomic alterations that are most relevant to diagnosis, therapy selection, prognosis, and clinical trial options in solid tumors. It Is appropriate for patients with newly diagnosed, recurrent, or resistant disease.
A block is preferred for testing: ≥20% tumor and ≥5 mm2 of tissue surface area for NGS (~500 tumor cells)
(additional 100 neoplastic cells for PD-L1).
If submitting 5-micron unstained slides, the following number of slides are requested:
- 10 unstained slides (2 sections per slide preferred) plus 1 additional unstained slide for H&E and 3 additional unstained slides for PD-L1 testing.
- Samples from cell block, FNAs, small needle core biopsies: 20 unstained slides (2 sections per slide preferred) plus 1 additional unstained slide for H&E and 3 additional unstained slides for PD-L1.
Use cold pack for transport, making sure cold pack is not in direct contact with specimen.
8-10 days*
*Published Turnaround time (TAT) begins from sample receipt at one of our NeoGenomics laboratories. Additional time (beyond published TAT) may be needed for New York state clients where findings require fusion confirmation testing per regulatory guidelines.