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2017-08-10

BioNTech Diagnostics GmbH and Metropolis Healthcare Ltd. Announce Partnership to commercialize new Breast Cancer Stratification Test

Strategic partnership to make BioNTech´s mRNA-based molecular breast cancer stratification test, MammaTyper®, commercially available in India, Sri Lanka, Kenya, Mauritius, Ghana and Zambia through Metropolis’ medical testing service laboratorie Partners combine their expertise in in vitro diagnostics and clinical testing services to enable precise characterization of breast cancer tumor types Mainz, Germany and Mumbai, India, …


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 …