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2017-05-15

BioNTech announces positive results of an international reproducibility study with MammaTyper®

International multicenter study in ten pathology laboratories in the U.S., Canada, Europe and Asia MammaTyper® provides highly reproducible quantitative results of the mRNA expression status of the four biomarkers HER2 (ERBB2), ER (ESR1), PR (PGR) and Ki-67 (MKI67) Mainz, May 15, 2017: BioNTech Diagnostics GmbH today announced the publication of an international prospective multicenter study …


2017-02-15

MammaTyper® enables more precise prediction of the response to neoadjuvent chemotherapy compared to manual or digitalized IHC

First comparison of a biomarker analysis by RT-qPCR (MammaTyper®) versus visual or computer-assisted immunohistochemistry (IHC) in subtyping mammary carcinomas Significantly more precise prediction of pathologically complete remission in a neoadjuvant setting with MammaTyper® compared to manual or computer-assisted IHC; better therapy stratification and possible avoidance of unnecessary therapies MammaTyper® provides reliable quantitative determination of MKI67-mRNA …


2016-08-19

Chinese FDA Grants MammaTyper® Innovative Product Status for Expedited Approval

Mainz, Germany and Deqing, China, August 19, 2016 — BioNTech Diagnostics GmbH, a fully owned subsidiary of BioNTech AG, and its Chinese partner Shuwen Biotech Co. Ltd. today announced that the Chinese FDA (CFDA) has granted the “Innovative Medical Product” status for MammaTyper®, a real-time PCR kit for breast cancer stratification. This diagnostic product will …


2016-07-12

Study confirms analytical precision of MammaTyper® in molecular breast cancer typing

Mainz, Germany, July 12, 2016:  BioNTech Diagnostics GmbH announces the publication of new study data which confirms the high analytical performance of the in vitro diagnostic test kit MammaTyper® (CE labeled IVD) in breast cancer subtyping [1]. MammaTyper® allows a precise quantitative determination of the mRNA expression of the biomarkers ERBB2 (HER2), ESR1 (ER), PGR …