BioNTech Diagnostics GmbH announced 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. MammaTyper allows a precise quantitative determination of the mRNA expression of the biomarkers ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (proliferation marker Ki-67), and a molecular subtyping of the tumor tissue according to the St. Gallen guidelines. Thus, MammaTyper provides an optimized tumor stratification, which is, among other things, a basis for the selection of an effective therapy for each patient.

According to Professor Arndt Hartmann of Erlangen University Hospital, “The results of the current study show that MammaTyper delivers reproducible quantitative values for the four biomarkers recommended in the St. Gallen guidelines - independently of individual laboratory conditions.” Dr. Sierk Poetting, Managing Director at BioNTech Diagnostics GmbH, commented: “Once again the MammaTyper test kit has been proven as an unambiguous technical advance in breast cancer subtyping.” The results of a prospective-retrospective clinical study published in May 2016 demonstrated MammaTyper´s essential advantages compared to established methods of detecting biomarkers with regard to disease free survival and overall survival.

There has been recent criticism of the established IHC and FISH/CISH methods to determine biomarkers, particularly, with respect to the reproducibility and comparability of the values for the marker Ki-67 (3-7). MammaTyper technology is based on the molecular determination of the mRNA expression of the four biomarkers from formalin-fixed and paraffin-embedded tumor tissue (FFPE), using the RT-qPCR method (reverse transcription quantitative real time polymerase chain reaction). Earlier studies have shown that this technology possesses essential advantages in comparison to IHC.

The present study contains an analytical validation of MammaTyper with respect to various parameters (laboratory site, content of tumor cells in the sample, method of RNA preparation). Therefore FFPE breast cancer samples, covering the whole range of the clinically expected levels of expression of the target genes, were measured under various conditions at three different sites and using different RT-qPCR systems with MammaTyper.

At a single site, the agreement between the results for the two tested RT-qPCR systems were 100 % for ERBB2, 96.9 % for ESR1, 97.2 % for PGR and 98.6 % for MKI67. MammaTyper achieved in total a mean correlation between the markers and the sites of more than 96 %. The individual determination of the markers with MammaTyper was stable up to a 64-fold dilution of a typical clinical sample. The MammaTyper results were also unaffected by up to 80% of surrounding non-tumor tissue, including in situ carcinoma.

Dr. Sierk Poetting commented, “This means that the results with the MammaTyper test kit are stable, even between different sites and under varying conditions. Thus, MammaTyper allows standardized, precise and reproducible breast cancer subtyping.”

With this accurate, quantitative and reproducible determination of biomarkers, MammaTyper can help to improve breast cancer diagnosis.

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 the possibility of significantly improving the diagnosis and, ultimately, the treatment of female patients with breast cancer. MammaTyper is intended for use by a doctor together with further clinical pathological factors. The test is very simple, and can be carried out in any pathology laboratory. The test 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.