Mainz, Germany, 11 June 2015: BioNTech AG, a fully integrated biotechnology company developing truly personalized cancer immunotherapies and its subsidiary BioNTech Diagnostics GmbH, today announced the launch of MammaTyper®, a CE-IVD marked molecular diagnostic test to stratify breast cancer patients by molecular subtyping of routine tumor tissue, for universal use in pathology laboratories. Based upon precise measurements of gene expression by RNA analysis, MammaTyper® has the potential to significantly improve the standard of diagnosis and ultimately treatment of breast cancer patients and underscores the Group’s commitment to its goal of making truly personalized medicine broadly available in oncology.
Expert medical European guidelines for breast cancer diagnosis and treatment recommend that all breast cancer be routinely subtyped using four well-established genetic markers. These analyses allow stratification of patients by the genetic subtype of the tumor, giving prognostic and predictive information so that optimal therapy can be chosen.
MammaTyper®, developed in collaboration with STRATIFYER, a molecular diagnostics company, is a molecular in vitro diagnostic test, based on RT-qPCR technology that allows a quantitative, accurate and reproducible detection of the mRNA expression levels of these four well established biomarkers (ESR1, PGR, ERBB2 and MKI67) of breast cancer tumors as recommended by the St Gallen Expert Committee1. The test can be used on all female patients with newly diagnosed invasive breast cancer and is now available in Europe and all countries that recognize the CE-standard. MammaTyper® has the added advantage that the test can be used in any molecular pathology laboratory with same-day results.
Sean Marett COO, of BioNTech, said: “The launch of our first product, MammaTyper®, demonstrates BioNTech’s true capabilities as a fully integrated and operational business. Launching MammaTyper® and other future diagnostics currently in development will help us to establish BioNTech in the oncology market, in preparation for launch of our immunotherapies for the treatment of cancer. The launch also underscores the Group’s commitment to its goal of making truly personalized medicine broadly available in the field of oncology. Each cancer is not a single disease. Different genetic subtypes require different therapies making correct genetic subtyping critical to treatment success. Within the BioNTech Group, BioNTech Diagnostics has a mission to provide new and innovative diagnostic tests to extend lives of patients, improve their quality of life and support the use of appropriate therapy for each individual patient.”
The MammaTyper® test can be used together with the recently introduced RNXtract® RNA Extraction Kit (IVD) which offers a reliable, robust and easy-to-use method to gain high quality amplifiable template RNA from formalin-fixed, paraffin embedded (FFPE) sample material. RNXtract® has been specifically designed for use with MammaTyper® and other tests from BioNTech Diagnostics’s development pipeline.
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About BioNTech AG
BioNTech AG is an immunotherapy leader with bench-to-market capabilities, developing truly personalized, well-tolerated and potent treatments for cancer and other diseases. Established by clinicians and scientists the Group is pioneering disruptive technologies ranging from individualized mRNA based medicines through innovative Chimeric Antigen Receptors /T-cell Receptor-based products and novel antibody checkpoint immunomodulators. BioNTech’s clinical programs are supported by an in-house molecular diagnostics unit whose products include MammaTyper® a molecular in-vitro diagnostic kit, marketed under CE and IVD marking in Europe and certain other countries. Founded in 2008, BioNTech is privately held, with Strüngmann Family Office as a majority shareholder, having closed the largest initial financing in the European biopharma sector’s history. Information about BioNTech is available at www.biontech.de.
About BioNTech Diagnostics GmbH
BioNTech Diagnostics is a fully-owned subsidiary company within the BioNTech AG Group. The ISO 9001/13485 certified company has extensive product and service offerings ranging from biomarker discovery and validation through molecular screening assays, patient stratification and companion diagnostics to clinical monitoring, all to international regulatory standards. Early detection of diseases that have a high mortality rate and the appropriate selection of therapies are crucial for a successful treatment of patients. BioNTech Diagnostics’ mission is to provide new and innovative diagnostic tests to extend lives of patients, improve their quality of life and support the use of appropriate therapy for each individual patient.