The NeoTYPE Colorectal Tumor Profile analyzes 44 biomarkers through a combination of next-generation sequencing (NGS), other molecular methods, FISH, and IHC as listed below. Test orders include summary interpretation of all results to help guide treatment decisions. If global HER2 Colorectal IHC result is 3+ of 11-49% and/or 2+ in ≥50% of cells, case will reflex to global HER2 Colorectal FISH 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%.
NGS (36 genes + 2 biomarkers): AKT1, ARID1A, APC, ATM, BRAF, EGFR, EPCAM, ERBB2, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, HRAS, KIT, KRAS, MET, Microsatellite Instability (MSI), MLH1, MSH2, MSH6, MUTYH, NOTCH1, NRAS, PDGFRA, PIK3CA, PMS2, POLD1, POLE, PTEN, RNF43, SMAD4, SMO, SRC, STK11, TERT Promoter, TP53, Tumor Mutation Burden (TMB)
FISH (3 FISH): MET, PTEN, RET (tech-only available)
IHC (3 biomarkers): HER2 Colorectal, PD-L1 LDT, Pan-TRK (tech-only available for HER2 and PD-L1)
The NeoTYPE Colorectal Tumor Profile characterizes primary or metastatic colorectal tumors of any histological subtype for the most significant genetic changes relevant to therapy decisions, prognosis, and clinical research. It is appropriate for patients with newly-diagnosed or recurrent disease, and for patients with resistant disease to explore options in clinical trials.
- 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.
14 days; add 1-3 days if reflexed to NTRK NGS Fusion Profile