China NMPA Approves Two Pathogen Metagenomic Detection Reagents

On August 31, 2026, the National Medical Products Administration officially approved two pathogen metagenomic detection reagent registration applications based on next-generation sequencing technology.

Approved Products:

l Respiratory Pathogen Nucleic Acid Detection Kit (Guangzhou Vision Medicals Co., Ltd., by combinatorial probe-anchor synthesis sequencing) — This kit qualitatively detects pathogen nucleic acids (including fungi, bacteria, atypical pathogens, and viruses) in human bronchoalveolar lavage fluid samples. It is intended for adjunctive diagnosis of lower respiratory tract infections in critically ill patients, immunocompromised patients, and difficult-to-diagnose cases. This is the world's first respiratory pathogen detection reagent based on metagenomic detection technology.

l Bloodstream Infection Pathogen Nucleic Acid Detection Kit (Tianjin Jin Shi Medical Technology Co., Ltd., by reversible terminator sequencing) — This kit qualitatively detects bacterial and fungal nucleic acids in human plasma samples. It is intended for adjunctive diagnosis in patients with suspected bloodstream infections where conventional diagnostic methods such as blood culture fail to identify the pathogen, as well as in severe and critical bloodstream infection cases including sepsis. This is the first domestically developed metagenomic detection reagent for bloodstream infections in China.

Technology Highlights:

Both approved products employ untargeted pathogen metagenomic high-throughput sequencing technology. A single test can simultaneously provide information on multiple categories of pathogens, effectively addressing the limitations of traditional methods such as narrow detection range and poor timeliness. They offer significant advantages in detecting difficult-to-culture and rare pathogens, providing more options for the adjunctive diagnosis of clinically challenging, severe, and special infection cases.

The drug regulatory authorities will strengthen post-market supervision of the above products to ensure patient safety.