Alternative Name
Colorectal Tumor Profile
Methodology
Molecular
Test Description

The NeoTYPE  Colorectal Tumor Profile analyzes 30 biomarkers through a combination of next-generation sequencing (NGS), other molecular methods, FISH, and IHC as listed below.  Test orders include summary interpretation of all results to help guide treatment decisions. If Pan-TRK IHC is expressed or indeterminate, NTRK NGS Fusion Profile for NTRK1 fusions, NTRK2 fusions, and NTRK3 fusions will be added by reflex.

  • NGS (23 genes + 1 biomarker): AKT1, APC, BRAF , EGFR, ERBB2, ERBB4, FGFR1, FGFR2, FGFR3, HRAS , JAK3, KIT, KRAS, MET, MLH1, NOTCH1, NRAS, PDGFRA, PIK3CA, PTEN, SMO, SRC, TP53,  and Tumor Mutation Burden (TMB)
  • Other Molecular (2 biomarkers): MLH1 Promoter Methylation, Microsatellite Instability Analysis (MSI)
  • FISH ( 2 FISH ): MET, PTEN (tech-only available)
  • IHC (2 biomarker): PD-L1 22C3, Pan-TRK (tech-only available for PD-L1)
     
Clinical Significance

The NeoTYPE Colorectal Tumor Profile characterizes primary or metastatic colorectal tumors of any histological subtype for the most significant genetic changes relevant to therapy decisions, prognosis, and clinical research. It is appropriate for patients with newly-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.
  • 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

Refrigerate fresh tissue in RPMI until shipping. For all specimens, use cold pack for transport, making sure cold pack is not in direct contact with specimen.

CPT Code(s)*
81445x1, 88377x2, 88360x1, 88342x1; add 81479x1 if reflexed to NTRK NGS Fusion Profile
Turnaround Time

14 days; add 1-3 days if reflexed to NTRK NGS Fusion Profile

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.