BioNTech Diagnostics GmbH announces 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.
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 and more). 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.
With this accurate, quantitative and reproducible determination of biomarkers, MammaTyper can help to improve breast cancer diagnosis.
BioNTech Diagnostics GmbH