China’s National Medical Products Administration (NMPA) has approved Sansure Biotech Inc.’s (SHA: 688289) Pneumocystis jirovecii, Cryptococcus neoformans, and Aspergillus nucleic acid detection kit, utilizing fluorescence PCR technology. This marks Sansure Bio’s first regulatory approval in fungal infection detection.
Significance of the Approval
The newly approved kit represents a significant advancement in the diagnosis of invasive pulmonary fungal disease (IPFD), offering a rapid and sensitive solution to address the limitations of existing detection methods.
Technical Advantages
The Sansure kit stands out with an industry-leading sensitivity of 500 copies/mL, enabling the rapid and highly sensitive detection of all three deadly fungi from a single sample. This innovation supports multiple sample types, including sputum and bronchoalveolar lavage fluid.
Market Compatibility
The kit is compatible with common PCR instruments on the market, making it a versatile and accessible tool for laboratories.-Fineline Info & Tech
