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 <b>10 biomarkers</b> using a combination of next-generation sequencing (NGS) and IHC, as listed below. Test orders include a summary interpretation of all results to help guide treatment decisions. HER2 (Other) IHC with Gastric Scoring (default) and HER2 Gastric/GEA options are available.<br><br>
<b>NGS (5 genes + MSI and TMB)</b><br>
BRAF, HRAS, KRAS, NRAS, TERT Promoter, Microsatellite Instability (MSI), Tumor Mutation Burden (TMB)<br>
A microsatellite instability (MSI) NGS result of "indeterminate" will reflex to PCR-based MSI testing, provided tumor content is ≥20% for colorectal specimens or ≥40% with paired normal tissue available for non-colorectal specimens.<br><br>
<b>IHC (3 biomarkers):</b><br>
* HER2 (Other) with Gastric Scoring (default) or HER2 Gastric/GEA<br>
Reflex rule:<br>
If HER2 (Other) with Gastric Scoring is selected and the result is 2+, the case will reflex to HER2 (Other) FISH with Gastric Scoring unless tech-only FISH or reflex opt-out is requested.<br>
If HER2 Gastric/GEA is selected and the result is 2+, the case will reflex to HER2 Gastric/GEA FISH unless tech-only FISH or reflex opt-out is requested.<br>
* PD-L1 22C3 (tech-only available)<br>
* Pan-TRK (tech-only available)<br>
Reflex rule:<br>
If Pan-TRK IHC is expressed or equivocal, the case will reflex to either the NTRK NGS Fusion Panel (default) or the NTRK 1–3 FISH Panel.</p>
<b>NGS (5 genes + MSI and TMB)</b><br>
BRAF, HRAS, KRAS, NRAS, TERT Promoter, Microsatellite Instability (MSI), Tumor Mutation Burden (TMB)<br>
A microsatellite instability (MSI) NGS result of "indeterminate" will reflex to PCR-based MSI testing, provided tumor content is ≥20% for colorectal specimens or ≥40% with paired normal tissue available for non-colorectal specimens.<br><br>
<b>IHC (3 biomarkers):</b><br>
* HER2 (Other) with Gastric Scoring (default) or HER2 Gastric/GEA<br>
Reflex rule:<br>
If HER2 (Other) with Gastric Scoring is selected and the result is 2+, the case will reflex to HER2 (Other) FISH with Gastric Scoring unless tech-only FISH or reflex opt-out is requested.<br>
If HER2 Gastric/GEA is selected and the result is 2+, the case will reflex to HER2 Gastric/GEA FISH unless tech-only FISH or reflex opt-out is requested.<br>
* PD-L1 22C3 (tech-only available)<br>
* Pan-TRK (tech-only available)<br>
Reflex rule:<br>
If Pan-TRK IHC is expressed or equivocal, the case will reflex to either the NTRK NGS Fusion Panel (default) or the NTRK 1–3 FISH Panel.</p>
Orderable Turn Around Time
14 Days
NY Approved
True
Orderable Biomarkers JSON
{"DNA Sequencing": {"SNVs + Indels": ["BRAF", "HRAS", "KRAS", "NRAS", "TERT"], "Genomic Signatures": ["MSI", "TMB"]}, "Immunohistochemistry (IHC)": {"Expression": ["HER2", "NTRK1", "NTRK2", "NTRK3", "PD-L1"]}, "Fluorescence In Situ Hybridization (FISH)": {"Amplification(s)": ["HER2"]}}
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.