Recently, the innovative product Human Breast Cancer Molecular Subtyping Quantitative Detection Kit (PCR-Fluorophore-labeling Probes) of BioNTech Diagnostics GmbH was approved by China NMPA.

　　This product consists of detection system mixture, enzyme mixture, a positive control and a negative control, and is used for in vitro semi-quantitative detection of the mRNA expression status of genes ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (Ki-67) in FFPE tissue section samples of invasive breast cancer.

　　It uses Taqman technology to quantitatively detect the mRNA expression status of four target genes (ERBB2, ESR1, PGR and MKI67) and two reference genes by real-time quantitative reverse transcription PCR (RT-qPCR). For cases that cannot be easily determined by traditional immunohistochemical analysis, and case samples with significant differences between the results of traditional immunohistochemical analysis and the treatment expectation, further detection can be provided to assist in determining the molecular subtyping of breast cancer and improve the accuracy of subtyping, ultimately assist doctors to develop a more reasonable diagnosis and treatment regimen.

　　The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.