The MammaTyper® test is optimized for usage in every molecular pathology laboratory.
MammaTyper® is based on quantitative one step RT-qPCR technology, combining reverse transcription of mRNA and subsequent quantitative PCR of the resulting cDNA. Signal detection is performed in real time by fluorescently labeled hydrolysis probes. Expression results are normalized against two reference genes. Additionally a calibrator corrects for inter-run and inter-instrument variations. Besides quantitative and highly reproducible performance data the test kit delivers fast and reliable results by ready-to-use assay mixes. The kit was validated using following real time PCR instruments: Versant® kPCR cycler, LightCycler® 480 Instrument II, cobas z 480 Analyzer, ABI 7500 Fast, Bio-Rad CFX96® and Mx3000P.
The MammaTyper® Kit was developed and validated for use with RNA, which was extracted and purified from formalin-fixed and paraffin-embedded (FFPE) breast cancer tissue samples using the RNXtract® RNA extraction kit, according to the manufacturer’s instructions for use. Eluates from the RNXtract® kit can be directly used in the MammaTyper® test.
With the fast and easy-to-handle RT-qPCR protocol, quantitative relative gene expression data of the four biomarkers can be generated within one day. MammaTyper® results show a high precision and intra-, inter-run reproducibility. A very low inter-site variation was shown in the course of technical validation of the test.
Therefore MammaTyper® precisely determines of the breast cancer subtype of a patient, the key for therapy decision and prognosis.