• MammaTyper® is superior to local immunohistochemistry (IHC) for measuring local gene expression in order to predict Oncotype DX®-type results1
• Use of MammaTyper® subtyping for prognosis of breast cancer suggests that endocrine therapy¬ may be adequate for patients with a low risk of relapse2
• This study demonstrated that MammaTyper® is a cost-effective method to identify low-risk patients.
Mainz, January 15, 2017:
BioNTech Diagnostics GmbH is announcing new results from two studies on the MammaTyper® test which were presented at the Breast Cancer Symposium in San Antonio in December.1,2 The results of these studies again demonstrate the benefits of breast cancer subtyping using MammaTyper® to predict the course of the disease and to aid in the selection of effective, tailored therapy. MammaTyper® allows precise, quantitative measurement of the mRNA expression of the ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (proliferation marker Ki-67) biomarkers, which in turn facilitates molecular subtyping of tumor tissue according to St. Gallen guidelines. MammaTyper® thus provides accurate molecular stratification of breast cancer, information which is required for the selection of effective therapy tailored to each patient.3 "Quantitative measurement of the expression levels of the four St. Gallen biomarkers was a much better predictor of Oncotype DX® Recurrence Score (RS) results than using traditional IHC methods" according to Dr. Mark Laible, Head of Molecular Pathology at BioNTech Diagnostics. "An additional study could show that the MammaTyper® test also helps physicians avoid overtreating certain patient groups, thus sparing patients from additional rounds of debilitating chemotherapy" added Dr. Sierk Pötting, CFO BioNTech Diagnostics GmbH.
The study results in detail:
Study on the ability of MammaTyper® to predict Oncotype DX®-type results by measuring local gene expression1
This retrospective study conducted in Germany and Switzerland was ...
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, …
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 …
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 …
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 …