In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents IV

3. Molecular Diagnostic Software

According to the statistics published on the website of the NMPA, in 2020, NMPA approved eight models, one is for fluorescent PCR data analysis, one is for chip data analysis, five are for sequencing data analysis, and one is for interpretation of tumor and genetic disease gene detection results. The NMPA approved a total of 15 software for molecular diagnostics in 2021, one of which is for fluorescence PCR data analysis, one is for pharmaco genomics data interpretation, and the other 13 are for sequencing data analysis. It can be seen that the amount of data obtained by sequencing is large, and special software is required for analysis. These software are used in conjunction with molecular diagnostic reagents.

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