D2 Digital PCR Platform Obtains Another Class III Certificate: TargetingOne Leads with the Top Two NMPA Class III Certificates for Digital PCR Platforms!

Recently, the D2 Digital PCR platform (Digital PCR Droplet Preparation and Analyzer) independently developed by TargetingOne was approved by the National Medical Products Administration (NMPA) to obtain a Class III medical device registration certificate (Registration Certificate No. for Medical Devices in China: 20253220394). This is the second digital PCR instrument product to be approved in just one month after the first approval of the D50 fully automatic digital PCR instrument of TargetingOne! The series of digital PCR platforms (D2, D50) of TargetingOne have NMPA Class III certificates. Previously, three types of approvals for diagnostic reagents, namely EGFR liquid biopsy detection reagents, hepatitis B DNA quantification detection reagents, and novel coronavirus nucleic acid detection reagents, have been obtained for clinical applications. So far, TargetingOne is the only digital PCR enterprise that holds both NMPA Class III certificates for instruments and reagents. This series of progress is of great significance for the practical clinical application of digital PCR technology, marking that TargetingOne is leading the digital PCR technology into the stage of clinical application implementation.

Authoritative Recognition: The Driving Force for Forging Ahead

The approval of the Class III certificate for TargetingOne’s digital PCR instruments is not only a recognition of the safety and effectiveness of the instruments themselves through strict national – level review and technical approval. More importantly, it opens a new door for domestic reagent manufacturers and provides an independent and controllable R & D environment. This allows domestic reagent manufacturers to develop reagents and conduct registration – related clinical trials on the digital PCR platform of TargetingOne with confidence.
This approval of TargetingOne not only consolidates its leading position in the domestic digital PCR field but also provides a molecular diagnostic tool with high sensitivity and excellent quantification ability for clinical applications, contributing to the realization of personalized medicine. With technological iterations and the expansion of indications, its products are expected to become core detection solutions in fields such as oncology, infectious diseases, and preconception and prenatal care, promoting the upgrading of China’s precision medicine industry.

About TargetingOne

Founded in 2015 and located in Zhongguancun Science Park, TargetingOne is a national high – tech enterprise and a “specialized, refined, characteristic, and innovative” enterprise in Beijing. It focuses on independent innovation in life sciences and molecular diagnosis and has a high – level R & D team in fields such as instruments, chips, materials, reagents, and software. The company has developed rapidly, applying for more than 200 domestic and international patents and obtaining more than 150 authorized patents. It has continuously published academic papers in authoritative journals and undertaken national – level scientific research funds. Based on its self – developed digital PCR technology with independent intellectual property rights, the company has obtained the first and second NMPA Class III medical device registration certificates for digital PCR instruments, as well as three NMPA Class III medical device registration certificates for diagnostic reagents. Among them, the digital PCR diagnostic reagents in the fields of infectious diseases and solid – tumor liquid biopsy are the first Class III registered diagnostic reagents in these areas. The company has won the Gold Award for Excellent Innovative Products in China’s in – vitro diagnosis twice, the overall championship of the Zhongguancun International Frontier Science and Technology Innovation Competition, and the Second Prize of Beijing Science and Technology. The company’s independently developed open – type molecular POCT all – in – one machine and qPCR rapid – detection reagents have both obtained NMPA Class III medical device registration certificates. Adhering to the concept of “Innovation Makes Precision Accessible”, the company develops advanced technologies with multi – parameter, high – throughput, automation, anti – contamination, and low – cost features, aiming to become a leading enterprise in life sciences and molecular diagnosis and serve life sciences, precision medicine, drug development, and health management.