Diagnostics

In Vitro Diagnostics

BioNTech Diagnostics GmbH develops and manufactures biomarker-based in vitro diagnostic devices (IVDD) and commercializes products through selected partners. The company is certified according to ISO 9001 and ISO 13458. The development of the first companion diagnostic product has been completed by obtaining CE/IVD mark in in March 2013. Two additional IVDD products, RNXtract® and MammaTyper®, were launched in 2015.

MammaTyper® is a molecular in vitro diagnostic test kit delivering a precise biomarker analysis, which allows the classification of breast cancer tumor subtypes by quantitative determination of mRNA expression of ER, PR, HER2 and Ki-67 in FFPE tissues. Therefore MammaTyper® helps physicians to determine a patient’s prognosis, select a therapeutic regime and predict therapeutic outcome.

RNXtract® – a sample preparation kit- offers a reliable, robust and easy to handle method to gain highly purified total RNA from formalin-fixed, paraffin-embedded (FFPE) tissue material.

More Information about MammaTyper®

For more details about MammaTyper® and for distributor information please visit our website: www.mammatyper.com

Contact our Customer Service:
Tel: +49-6131-9084-2001
E-Mail: service@sales.biontech.de