BioNTech Diagnostics MammaTyper® – Innovation for breast cancer diagnostics
MammaTyper® is a RT-qPCR in vitro diagnostics assay used to quantitatively measure the mRNA expression status of breast cancer marker genes in invasive breast cancer. The test involves genes ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (Ki-67), which are used to stratify invasive breast cancer into surrogate subtypes according to St Gallen classification 2013.
Accurate determination of molecular subtypes is one of several key elements for defining the optimal therapy choice in breast cancer. The MammaTyper® test is applicable in all female breast cancer cases as a primary or a secondary diagnostic test. It can be used as an alternative to IHC and in situ hybridization (FISH/CISH) or to verify unclear IHC results. The results of MammaTyper® test are easy to interpret and based on clinically verified cut-off values.
- Gaining precise quantitative results for marker gene expression – overcoming the limitations of semi-quantitative staining methods
- Robust subtyping of breast cancer; results ready within one day with low inter-/intra-laboratory variations
- Carrying out personalized and breast cancer subtyping based cancer treatment
|Products available||MammaTyper® Kit for 10 determinations|
|Use||For in vitro diagnostic use|
|Sample type||FFPE breast cancer tissue samples with tissue content of invasive tumor at least 20%|
|Time to result||1 day (6 hours minimum)|
|Storage||-25… -15°C, dark|
|Additionally needed||Validated RNA Extraction method is RNXtract® RNA Extraction Kit. Validated real-time PCR instruments include Siemens Versant® kPCR cycler, Roche LightCycler® 480 Instrument II, Roche Cobas z 480 Analyzer, ABI 7500 Fast, Bio-Rad CFX96® and Agilent Techonologies Mx3000P.|
More information available: https://www.mammatyper.com/