NeoTYPE® GI Predictive Profile

Code
NTG-GIPX-02CX
Profile
Active-Compendium
81457x1, 88360x2, 88342x1; add 88374x1 if HER2 IHC is reflexed to FISH; add 81479x1 if reflexed to NTRK NGS Fusion Panel (default) or 88374x3 automated (88377x3 manual) if reflexed to NTRK 1-3 FISH Panel
81479
Clinical
Oncology,Pathology
FFPE tissue: Paraffin block preferred. Please use 10% buffered formalin fixative. Do not use zinc fixatives.
Flag Active
True
Orderable Test Description
<p>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 &ge;20% for colorectal specimens or &ge;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).</p>
Orderable Turn Around Time
14 Days
Meta Description
<p>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.</p>
NY Approved
True
Orderable Biomarkers JSON
{"DNA Sequencing": {"SNVs + Indels": ["HRAS", "KRAS", "TERT", "NRAS", "BRAF"], "Genomic Signatures": ["MSI", "TMB"]}, "Fluorescence In Situ Hybridization (FISH)": {"Amplification(s)": ["HER2"]}, "Immunohistochemistry (IHC)": {"Expression": ["HER2", "NTRK1", "NTRK2", "NTRK3", "PD-L1"]}}
Keywords string
precision profile, solid tumors, neo type, NeoTYPE Precision Profile for Solid Tumors. NeoTYPE® GI Predictive Profile
Title URL
neotype-gi-predictive-profile
TAT Details

NGS: 14 Days
IHC: Global: 2 Days
          Tech-Only (stain
          only): 24 Hours
Potential Reflex Testing (Additional Time):
MSI by PCR: 5 Days
HER2 FISH: 5 Days
NTRK 1-3 FISH: 5 Days
NTRK NGS: 1-3 Days

Storage and transportation
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.