The NeoTYPE GI Predictive Profile analyzes 10 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. HER2 (Other) IHC w/Gastric Scoring (default) and HER2 Gastric/GEA options are available. If global HER2 (Other) IHC w/Gastric Scoring is selected and the result is 2+, the case will reflex to global HER2 (Other) FISH w/Gastric Scoring unless reflex to tech-only FISH or reflex opt-out is requested. If global HER2 Gastric/GEA is selected and the result is 2+, the case will reflex to global HER2 Gastric/GEA 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% for colorectal specimens or ≥40% with paired normal tissue available for non-colorectal specimens.
- NGS (5 genes + 2 biomarkers): BRAF, HRAS, KRAS, Microsatellite Instability (MSI), NRAS, TERT Promoter, Tumor Mutation Burden (TMB)
- IHC (3 biomarkers): HER2 (Other) w/Gastric Scoring (default) or HER2 Gastric/GEA, PD-L1 22C3, Pan-TRK (tech-only available for HER2 and PD-L1)
The NeoTYPE GI Predictive Profile characterizes GI tumors of any histological subtype for the most significant genetic changes relevant to therapy decisions, prognosis, and clinical research. It is especially relevant to colorectal or gastroesophageal tumors. It is appropriate for patients with new-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. All slides can be packed at room temperature.
14 days; add 1-3 days if reflexed to NTRK NGS Fusion Profile