MammerTyper® is an innovative molecular in vitro diagnostic test (IVD) which determines the expression status of the four most 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) und Triple negative (ductal) tumors (according to St Gallen classification 2013).
The MammaTyper® test is applicable in all female breast cancer cases as a primary diagnostic test (biopsy), for the analysis of resection specimens and metastases, as a second method in the case of unclear IHC results, or as a fast test for ERBB2 (HER2) determination, as an alternative to IHC and in situ hybridization (FISH/CISH).
Accurate determination of molecular subtypes is one of several key elements for defining the optimal therapy choice. 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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