BioNTech Diagnostics GmbH announced new results from a clinical performance evaluation study of the CE-marked IVD MammaTyper® which were presented at the European Society for Medical Oncology (ESMO) in Munich in October.(1,2)

For this prospectively planned study samples from the TECHNO and PREPARE trial cohorts were used to validate a pre-defined score and cut-off integrating highly standardized mRNA measurements of ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (Ki-67) by MammaTyper®. The score allows the prediction of pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) based on the pre-treatment biopsy. The cut-off accurately separates patients with a good response rate from patients with a low probability of pCR for which a different treatment than NACT or additional post-neoadjuvant treatment may be considered.

Additionally it was demonstrated that standardized measurement of ERBB2, ESR1, PGR and MKI67 mRNA is comparable to the determination of the markers on IHC level and is strongly associated with response to NACT as well as long-term outcome.

Within the group of HER2-positive patients from the TECHNO trial ERBB2 mRNA predicted pCR in the subgroup of ESR1 positive samples and may carry additional information that may help to better predict response based on the pre-treatment biopsy.

"Achieving a pCR after NACT in breast cancer (BC) is strongly associated with long-term disease-free survival. Although the prognostic impact of pCR on different BC subtypes may vary, achieving pCR remains an important factor in clinical decision-making", said Prof. Dr. med. Sibylle Loibl, CEO of GBG Forschungs GmbH and chair of the German Breast Group. "Reliable procedures for predicting pCR before treatment are limited as current predictors of pCR like imaging, clinical and histopathological parameters may need improvement before implementation in clinical routine".

These studies demonstrated that the MammaTyper® test, with its accurate and reproducible assessments of ERBB2, ESR1, PGR and MKI67 mRNA levels from pre-treatment biopsy, could be used as a valid predictor of the likelihood of complete pathologic remission after neoadjuvant chemotherapy treatment. A standardized predictive model has been used successfully in combination with other clinic-pathological factors facilitating the identification of patients who most likely will not respond to neo-adjuvant chemotherapy and therefore helps clinicians in deciding on the therapeutic approach.

About MammaTyper®
MammaTyper® is a molecular in vitro diagnostic test for quantitative detection of the mRNA expression status of the genes ERBB2 (HER2), ESR1 (ER), PGR (PR) and of MKI67 (proliferation marker Ki-67) in the tumour tissue of female patients with newly diagnosed invasive breast cancer. The test has been validated for total RNA extracted from tissue specimens or biopsies.

MammaTyper® is used for molecular subtyping of breast cancer tissue according to the St Gallen classification (2013) in luminal A-like, luminal B-like (HER2 negative), luminal B-like (HER2 positive), HER2 positive (non-luminal) and triple negative (ductal) tumours, and offers together with further clinical pathological factors the possibility of significantly improving the diagnostic and the treatment of female patients with breast cancer. The test can be carried out in any pathology laboratory. MammaTyper® can be used on all female patients with newly diagnosed invasive breast cancer and provides the results on the same day. With MammaTyper®, BioNTech underlines its commitment to making personalized medicine generally available in the field of cancer treatment.

About BioNTech AG
BioNTech AG, is a leader in the field of immunotherapy and develops innovative drugs for the individualized treatment of cancer and prevention of infectious diseases, such as seasonal influenza (flu). Established by clinicians and scientists the Group is furthermore 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 as IVD under CE marking in the European Union (and Switzerland) and in 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.

About BioNTech Diagnostics GmbH
BioNTech Diagnostics is a fully-owned subsidiary company of BioNTech AG. 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 cancer diseases 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.

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