BioNTech, along with its subsidiary BioNTech Diagnostics, announced that it has introduced CE-IVD marked breast cancer diagnostic test, MammaTyper, in the Europe.
MammaTyper molecular diagnostic test has been developed to stratify breast cancer patients by molecular subtyping of routine tumor tissue for universal use in pathology laboratories.
BioNTech COO Sean Marett said: "The launch of our first product, MammaTyper, demonstrates BioNTech’s true capabilities as a fully integrated and operational business.
"Launching MammaTyper and other future diagnostics currently in development will help us to establish BioNTech in the oncology market, in preparation for launch of our immunotherapies for the treatment of cancer."
Developed in partnership with molecular diagnostics company Stratifyer, the MammaTyper is a molecular in vitro diagnostic test that is based on RT-qPCR technology.
The technology allows quantitative, accurate and reproducible detection of the mRNA expression levels of four biomarkers, including ESR1, PGR, ERBB2 and MKI67, of breast cancer tumors as recommended by the St Gallen Expert Committee.
According to the firm, the test can be used on all female patients with newly diagnosed invasive breast cancer in any molecular pathology laboratory with same-day results.
The MammaTyper test can be used with the firm’s RNXtract RNA Extraction Kit (IVD) that offers easy-to-use method to gain better quality amplifiable template RNA from formalin-fixed, paraffin embedded (FFPE) sample material.