MammaTyper is an innovative molecular in vitro diagnostic test (IVD) which determines the mRNA expression status of the four important breast cancer biomarkers ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (marker of proliferation Ki-67) in a quantitative and reproducible way by means of RT-qPCR. This test is used for molecular subtyping of breast cancer tissue into Luminal A-like, Luminal B-like (HER2 negative), Luminal B-like (HER2 positive), HER2 positive (non-luminal) and Triple negative (ductal) tumors (according to St Gallen classification 2013).
Accurate determination of molecular subtypes is one of several key elements for defining the optimal therapy strategy. MammaTyper helps to improve subtyping by providing a reproducible, quantitative measurement of marker gene expression. This way MammaTyper helps pathologists to overcome limitations of semi-quantitative staining methods.
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