NeoTYPE® GI Predictive Profile
Use
The NeoTYPE GI Predictive Profile aims to provide comprehensive genetic profiling of gastrointestinal tumors. This test is intended to guide treatment decisions by analyzing a panel of 10 biomarkers, including DNA mutations, genomic signatures, and protein expressions. It helps in identifying actionable genetic alterations and genomic signatures that can potentially be targeted by specific therapies, thus supporting precision medicine efforts in oncology.
Special Instructions
For cases with HER2 IHC 2+ results, reflex testing to FISH is available unless otherwise opted out. For Pan-TRK IHC expression or equivocal results, reflex testing can be performed to either the NTRK NGS Fusion Panel or the NTRK 1-3 FISH Panel. Microsatellite instability (MSI) NGS results indicating 'indeterminate' can reflex to MSI by PCR under specific conditions regarding tumor percentage. IHC and PCR reflexes require additional processing time.
Limitations
The test is limited to the biomarkers and genes specified in the panel; it does not cover the entire genome or all possible genetic mutations. Reflex testing is conditional and relies on results of initial tests. HER2 testing results are subject to variability based on scoring systems used. The test requires FFPE tissue samples, and improper handling or fixative use can affect result accuracy. External factors such as tumor percentage can influence reflex eligibility for certain adjunct tests like MSI by PCR.
New York Approved
Methodology
NGS (Targeted)
Biomarkers
Result Turnaround Time
14 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
FFPE tissue: Paraffin block preferred. Please use 10% buffered formalin fixative. Do not use zinc fixatives.
Storage Instructions
Use cold pack for transport, ensuring it is not in direct contact with the specimen.