NeoTYPE® Colorectal Tumor Profile

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. 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 (Other) IHC w/Gastric Scoring result is 2+, case will reflex to global HER2 (Other) FISH w/ Gastric 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%.

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 (Other) w/Gastric Scoring, PD-L1 LDT, Pan-TRK (tech-only available for HER2 and PD-L1).