BioNTech has announced the launch of its MammaTyper, a CE-IVD marked molecular diagnostic test to stratify breast cancer patients by molecular subtyping of routine tumour tissue.
Based upon precise measurements of gene expression by RNA analysis, MammaTyper has the potential to significantly improve the standard of diagnosis and treatment of breast cancer patients.
Medical European guidelines for breast cancer diagnosis and treatment recommended that all breast cancer be routinely subtyped using four well-established genetic markers.
These analyses allow stratification of patients by the genetic subtype of the tumour, giving prognostic and predictive information so that optimal therapy can be chosen.
The MammaTyper, developed in collaboration with Stratifyer, a molecular diagnostics company, is a molecular in vitro diagnostic test.
The test can be used on all female patients with newly diagnosed invasive breast cancer and is now available in Europe.
Sean Marett, COO, of BioNTech, 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 the launch of our immunotherapies for the treatment of cancer.
“Different genetic subtypes require different therapies making correct genetic subtyping critical to treatment success.”