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We know that you’ll have your own questions about MammaTyper®, we would very much like to support your first evaluations and transition to molecular testing. Here are a selection of key facts and links to other key resources that may be useful to you.

The MammaTyper® kit is an in vitro diagnostic test for the quantitative detection of mRNA expression of Breast Cancer biomarkers. Human epidermal growth factor receptor 2 HER2 (ERBB2), estrogen receptor (ESR1), progesterone receptor (PGR), and marker of proliferation Ki-67 (MKI67) can be measured with this kit. Additionally, 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) tumours.
The results delivered (efficiently and accurately) by the test are furthermore prognostic for a patient’s risk of developing distant metastases as well as over-all survival.

All decisions related to treatment and therapy are based on the tumour subtype of the Breast Cancer. The subtype is defined by presence or absence of over-/expression of certain target genes. Since some therapies are aiming at these specific targets (eg, hormone receptors, HER2), a pre-requisite for therapy response is the presence of these targets in the tumour and precise determination of target expression. MammaTyper® is an in vitro diagnostic test which is highly suitable to accomplish this purpose.

In total, the RNA expression of the four biomarkers is measured via RT-qPCR using hydrolysis probes (FAM, JOE labeled). For the purpose of normalization, the expression of two additional genes with non-varying expression - so called reference genes - is measured. The four disease-relevant biomarkers are ERBB2, ESR1, PGR, and MKI67, and the two references genes are B2M and CALM2. The kit size allows the analysis of a maximum of 8 patient samples in triplicate, together with a positive and a negative control in one run. A maximum of two runs (10 determinations in total) is possible with one MammaTyper® kit.

The MammaTyper® test is appropriate for female patients who have been diagnosed with invasive Breast Cancer only. The test can be used for primary diagnostics of FFPE core needle biopsies, as well as for characterisation of resection specimens and metastases. The test has not to this date been validated in male patients, in pregnant women, or in patients with mucinous, papillary, medullary or tubular type of Breast Cancer (when no metastases are present in the ipsilateral axillary lymph nodes).

The MammaTyper® kit was developed and validated using total RNA extracted from formalin-fixed, paraffin-embedded (FFPE) Breast Cancer tissue samples. It is recommended to use the RNXtract® RNA extraction kit for pre-analytic processing of the FFPE material, although other RNA extraction kits, such as Qiagen, have been validated according to the MammaTyper® instructions for use. Eluates from the RNXtract® kit can directly be used in RNA specific RT-qPCR reactions.

The MammaTyper® kit was validated on the following instruments: LightCycler®480instrument II
cobasz®480 Analyser, Versant®kPCR AD module, ABI7500Fast system, CFX96 (BIO-RAD), MX3000P (Agilent). As described in the instructions for use, some additional small appliances and a plate centrifuge are necessary to most effectively perform the test.

The analysis can be performed in any professional molecular pathology laboratory. To avoid contamination with PCR products, separated areas for RNA isolation, RT-qPCR preparation, and measurement are recommended (pre- and post-PCR). Interpretation of the test results may only be made by a physician in combination with other clinico-pathological factors. The patient’s clinical history and any additional diagnostic test results that have been generated should be included in any decision making with regard to therapy.

One 10 µm FFPE tissue section is needed to perform the testing. Tumour cell content of the Breast Cancer tissue sample has to be at least 20 % as determined by a pathologist.

RNA isolation and the MammaTyper® test can be performed and analysed within one day

MammaTyper® is a precise and easily replicated test for the determination of quantitative RNA expression of the four Breast Cancer biomarkers (ERBB2, ESR1, PGR and MKI67) and overcomes the observer variability that has become problematic from other methods within immunohistochemistry. The test can be performed in one day - from sample to result. MammaTyper® is applicable for local testing in molecular pathology and/or routine IVD laboratories. It is currently the only test available that gives: • a) Information about the four Breast Cancer biomarkers (as recommended by the St Gallen expert panel, 2013) • b) Prognostic information about a patient’s risk of developing distant metastases, as well as about their over-all survival With MammaTyper®, a reliable and accurate tumour classification into the five subtypes Luminal A-like, Luminal B-like (HER2 positive), Luminal B-like (HER2 negative), HER2 positive (non-luminal) and Triple negative (ductal) is entirely possible. Good news for healthcare providers – and indeed their patients.