FAQs for Oncologists

The MammaTyper® is an in vitro diagnostic test for the quantitative detection of mRNA expression of breast cancer biomarkers. This genetic test is intended for molecular subtyping into Luminal A-like, Luminal B-like (HER2 positive), Luminal B-like (HER2 negative), HER2 positive (non-luminal) and Triple negative (ductal) tumors. The test result is furthermore prognostic for a patient’s risk of developing distant metastases and overall survival.

A therapy decision is based on the tumor subtype. The subtype is defined by presence or absence of over-/expression of certain target genes. Since some therapies are aiming at these specific targets (e.g. hormone receptors, HER2), a prerequisite for therapy response is the presence of these targets in the tumor and precise determination of target expression.

The four disease-relevant biomarkers recommended by the St Gallen expert panel – ERBB2, ESR1, PGR and MKI67 are tested in the assay.

MammaTyper® is a precise and reproducible test for the quantitative RNA expression of the four breast cancer biomarkers ERBB2, ESR1, PGR and MKI67 and overcomes inter-operator/observer variability known from other methods like immunohistochemistry.

The MammaTyper test is appropriate for female patients, diagnosed with invasive breast cancer only. The test can be used for primary diagnostics of FFPE core needle biopsies as well as for characterization of resection specimens. It is not applicable for men, pregnant women and in patients with mucinous, papillary, medullary or tubular type of breast cancer, when no metastases are present in the ipsilateral axillary lymph nodes.