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Clinician overview

The issue with current traditional methods (IHC) in screening and subtyping, is that they are impacted by inter and intra- laboratory variability. This in turn results in inconsistent diagnostic outcomes among patients. This inconsistency can then directly impact clinical decision-making in relation to effective treatment planning for Breast Cancer patients. We know this needs to change and progress for the good of Oncology as a practice, as well for that of the patients who place their lives in our hands.

MammaTyper® is a standardised multiplex real-time qPCR assay.

It allows pathologists to amplify, detect and quantify the mRNA expression status of ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (marker of proliferation Ki-67) to most appropriately and accurately subtype Breast Cancer in the patients we treat (as recommended by St Gallen, 2013 and subsequent updates). This not only makes things much easier for practitioners to work with as they set about prognosis and treatment plans, but also makes for more informed, settled and cared-for patients, which allows the whole pathway to become a lot smoother and more cooperative as we approach treatment.

The MammaTyper® test result is prognostic for the patient’s risk of developing distant metastases and allows a prognosis of overall survival (see Instructions for Use of MammaTyper®).

Quantitative determination of the mRNA expression of MKI67 in combination with the other three marker results helps to predict if administration of taxanes in addition to adjuvant chemotherapy is beneficial for a patient or if application of neoadjuvant chemotherapy is beneficial for a patient (see Instructions for Use of MammaTyper®).

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