NeoTYPE® Breast Tumor Profile

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. The NeoTYPE Breast Tumor Profile analyzes 60 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 equivocal, reflex to either NTRK NGS Fusion Panel (Default) or NTRK 1-3 FISH Panel will be added. A microsatellite instability (MSI) NGS result of "indeterminate" will create a reflex to MSI by PCR as long as the tumor percentage is ≥40% and paired normal tissue is available.

NGS (54 genes + 2 biomarkers):
AKT1, ARID1A, ATM, ATR, BARD1, BRAF, BRCA1, BRCA2, BRIP1, CDH1, CDK12, CHEK1, CHEK2, CTNNB1, EGFR, ESR1, ERBB2, ERBB4, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, FGFR1, FGFR2, FGFR3, GATA3, HRAS, KIT, KRAS, MET, Microsatellite Instability (MSI), MLH1, MRE11A (MRE11), MSH2, MSH6, NBN, NRAS, PALB2, PIK3CA, PMS2, PTEN, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, SMAD4, SMO, SRC, TERT Promoter, TP53, Tumor Mutation Burden (TMB)

FISH (2 FISH):
MET, PTEN (tech-only available)

IHC (2 biomarkers):
PD-L1 22C3, Pan-TRK (tech-only available for PD-L1).