The NeoTYPE Precision Profile analyzes 83 biomarkers through a combination of next-generation sequencing (NGS) 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, 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.
NGS (79 genes + 2 biomarkers): AKT1, ALK, APC, ARAF, ATM, ATR, BARD1, BRAF, BRCA1, BRCA2, BRIP1, CDH1, CDK12, CDKN2A, CHEK1, CHEK2, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, ESR1, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, FBXW7, FGFR1, FGFR2, FGFR3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, KDR, KIT, KRAS (includes G12C mutation), MAP2K1, MET, Microsatellite Instability (MSI), MLH1, MSH2, MSH6, MRE11A (MRE11), MTOR, NBN, NF1, NOTCH1, NRAS, PALB2, PDGFRA, PIK3CA, PMS2, PTCH1, PTEN, PTPN11, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TSC1, TSC2, TERT Promoter, TP53, Tumor Mutation Burden (TMB), VHL
IHC (2 biomarkers): PD-L1 LDT, Pan-TRK (tech-only available for PD-L1)
Molecular profiling with the NeoTYPE™ Precision Profile for Solid Tumors allows for the accurate and sensitive detection of somatic mutations in the genes most relevant to various solid tumor cancers. 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™ Precision Profile for Solid Tumors can also be used in current or future clinical research projects.
- FFPE solid tumor tissue: Paraffin block is preferred. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
Use cold pack for transport, making sure cold pack is not in direct contact with specimen.