Language

MammaTyper® Key Characteristics

Molecular in vitro diagnostic test for the four most important breast cancer biomarkers ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (marker of proliferation Ki-67)

  • RT-qPCR is a stable and reproducible process revealing reliable and precise results
  • Precise quantitative detection of mRNA expression of each marker via RT-qPCR
  • Combination of the four marker results allows accurate molecular subtyping of tumor tissue acc. to St Gallen into five subtypes:
ERBB2 ESR1   PGR    MKI67 St Gallen Subtype 1
pos pos pos pos Luminal B-like (HER2 positive)
pos pos pos neg Luminal B-like (HER2 positive)
pos pos neg pos Luminal B-like (HER2 positive)
pos pos neg neg Luminal B-like (HER2 positive)
pos neg pos pos not defined 1 class. 2013
pos neg pos neg not defined 1 class. 2013
pos neg neg pos HER2 positive (non-luminal)
pos neg neg neg HER2 positive (non-luminal)
neg pos pos pos Luminal B-like (HER2 negative)
neg pos pos neg Luminal A-like
neg pos neg pos Luminal B-like (HER2 negative)
neg pos neg neg Luminal B-like (HER2 negative)
neg neg pos pos not defined 1 class. 2013
neg neg pos neg not defined 1 class. 2013
neg neg neg pos Triple negative (ductal)
neg neg neg neg Triple negative (ductal)
1 Subtype definition according to 13th St Gallen guidelines (Goldhirsch et al. 2013)

St Gallen International Breast Cancer Conference (2013) Expert Panel recommends stratification of breast cancer into the aforementioned molecular subtypes and provides systemic treatment recommendations for each subtype.

The MammaTyper® kit uses RNA extracted from standard formalin-fixed, paraffin-embedded (FFPE) sample material from clinical routine and allows to streamline the molecular pathology workflow to have reliable same day results, including ERBB2 (HER2) results.