On April 2, 2025, the fully automated digital PCR instruments (AD3205, AD3207) independently developed by Pilot Gene were approved by the National Medical Products Administration (NMPA) and obtained the Class III Medical Device Registration Certificate (Registration No.: National Medical Device Approval 20253220709). Following the approval of the "Nucleic Acid Detection Kit for Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii (Digital PCR Method)" for a Class III Medical Device Certificate at the beginning of this year, this marks another blockbuster product of Pilot Gene receiving registration approval in just two months. With the consecutive issuance of two certificates, Pilot Gene has set a new industry record with its "hardcore speed". Currently, Pilot Gene's certified products on the digital PCR platform include the Automated Nucleic Acid Detection Reaction Setup System (AP10) and the Semi-Automated Digital PCR System (D3200). The certification of the fully automated digital PCR instruments indicates that Pilot Gene's platform layout has become increasingly improved. Coupled with the certification of bloodstream infection detection kits, this signifies that Pilot Gene is about to open a new chapter of full automation in the field of precise diagnosis of bloodstream infections.
Independently developed by Pilot Gene, the 7-color fluorescence fully automated digital PCR instrument integrates droplet generation, PCR amplification, and multi-channel fluorescence detection and analysis. It only takes 2 hours from sample loading to result output, truly achieving unattended operation. Equipped with a complete automation system, supporting reagents and consumables, and user-friendly interpretation software, the fully automated digital PCR instrument can provide users with a more comprehensive, high-performance, and easy-to-operate solution.
Product Features
➣ Fully Automated: Integrated equipment simplifies experimental operations and achieves unattended operation.
➣ Multi-Channel: 7-color fluorescence channels enable single-tube multiplex detection.
➣ Fully Closed System: The entire process of droplet generation, PCR amplification, and scanning analysis adopts a closed system to avoid aerosol contamination.
➣ High Efficiency: The entire process takes as fast as 2 hours.
