Alternative Name
Breast Tumor Profile
Methodology
Molecular
Test Description

The NeoTYPE Breast Tumor Profile analyzes 28 biomarkers through a combination of next-generation sequencing (NGS), 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, BRAF, BRCA1, BRCA2, CTNNB1, EGFR, ESR1, ERBB2, ERBB4, FGFR1, FGFR2, FGFR3, HRAS, KIT, KRAS, MET, NRAS, PIK3CA, PTEN, SMAD4, SMO, SRC, TP53, Tumor Mutation Burden (TMB)
  • FISH (2 FISH ): MET, PTEN (tech-only available)
  • IHC (2 biomarker): PD-L1 SP142, Pan-TRK (tech-only available for PD-L1)
Clinical Significance

The NeoTYPE Breast Tumor Profile characterizes primary or metastatic breast 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.

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.