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FAQs for Oncologists

What is MammaTyper®

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.

Why is it important to characterize breast cancer tumors?

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.

Which markers are tested and how many samples can be analyzed?

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

What is the advantage of MammaTyper as the above markers can be tested even by
immunohistochemistry?

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.

For which patient population should MammaTyper be used?

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.

Where can the test be performed? Is it an international send out test?

This test is available in India and is performed in the molecular pathology division of Metropolis
Healthcare Ltd., Mumbai. It is certainly not an international send out test.

What is the specimen type? How much tumor material is necessary for the testing?

The assay is performed on FFPE tissue block. Tumor cell content of the breast cancer tissue sample has
to be at least 20 % as determined by a pathologist.

Which technique or method is used?

The MammaTyper assay uses one-step reverse transcription quantitative real-time PCR (RT-qPCR) for
expression analysis of ERBB2, ESR1, PGR, and MKI6.

How long does it take to get the result?

Unlike other molecular tests that take 6-8 weeks, MammaTyper results get ready in 20 days.