Methodology
Molecular
Test Description

This test is performed by sequencing of select exons of the genes listed unless another method is noted: BRAF, HRAS, KRAS, Microsatellite Instability Analysis (MSI), NRAS, HER2 FISH, PD-L1 IHC. MSI is performed by fragment analysis. Tumor Mutation Burden (TMB) testing and individual genes from a validated list of genes can be added. Test orders include summary interpretation of all results together. FISH components of NeoTYPE Profiles may be ordered as "Tech-Only" by pathology clients who wish to perform the professional component.

Clinical Significance

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.

Specimen Requirements
  • FFPE tissue: Paraffin block preferred. Please use 10% buffered formalin fixative. Do not use zinc fixatives.
  • Fresh tissue: 1 cm3 fresh tissue that is mostly tumor in RPMI.
  • Fine needle aspirate (FNA): FNA samples are not accepted for specimens having Tumor Mutation Burden testing. For other samples, requisition must note specimen is FNA. FFPE cell blocks are acceptable if pathologist attaches note verifying sample has >30% tumor or abnormal cells (required). FNA smears or cells in suspension are not accepted.
  • Note: An additional patient sample from normal, non-tumor tissue is required for comparison testing in MSI Analysis. Please submit all specimens with one test requisition form.

Specimen requirements for normal tissue in order of preference are:

  •  5 mL peripheral blood in EDTA tube
    or
  •  FFPE tissue slides or block containing only non-tumor tissue. Please label these as "normal tissue".
    or
  • In cases where no alternative tissue is available, we can attempt to isolate non-tumor tissue from FFPE tumor specimen submitted. Note "Use tumor sample for normal tissue" on requisition.
Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. All slides can be packed at room temperature.

CPT Code(s)*
81479x1, 88374x1, 88360x1, add 81479x1 if Tumor Mutation Burden is ordered.
Turnaround Time

14 days

Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.