ShuWen Biotech Co., Ltd, a biopharmaceutical company based in Zhejiang, has announced that its MammaTyper diagnostic kit has received market approval from the National Medical Products Administration (NMPA). The kit is intended for use in cases where immunohistochemistry (IHC) results are indeterminate or unsatisfactory, or when the IHC outcome significantly deviates from treatment expectations. MammaTyper is designed to further assist in determining the molecular classification of breast cancer, providing a more accurate diagnostic tool in challenging scenarios.
MammaTyper represents an innovative approach in molecular in vitro diagnostic testing (IVD), quantifying and reproducibly assessing the expression status of the four most critical breast cancer biomarkers: ERBB2 (HER2), ESR1 (ER), PGR (PR), and MKI67, a marker of proliferation Ki-67. The test employs reverse transcription quantitative polymerase chain reaction (RT-qPCR) technology to deliver precise results. Notably, MammaTyper is co-developed by Germany-based BioNTech, highlighting a synergy between Chinese and German biotechnological expertise.- Flcube.com
