Milestone! TargetingOne Obtains the First Class III NMPA Certificate for Digital PCR Instrument

Recently, the D50 automatic digital PCR instrument independently developed by TargetingOne was approved by the National Medical Products Administration to obtain the Class III medical device registration certificate (Registration No.: 20253220212). This is also the first approved digital PCR instrument platform since the National Medical Products Administration issued a document in March 2022 clearly stating that digital PCR should be managed as Class III medical devices. This breakthrough is of great significance for the practical clinical application of digital PCR technology and can be regarded as an important milestone. It is worth mentioning that TargetingOne had previously obtained three types of approvals for EGFR liquid biopsy detection reagents, hepatitis B DNA quantitative detection reagents, and novel coronavirus nucleic acid detection reagents. This series of achievements marks that TargetingOne is leading the digital PCR technology into the stage of clinical application implementation.

Striving Forward and Deeply Ploughing in the Field of Digital PCR

Since its establishment, TargetingOne has been dedicated to the research and exploration of molecular diagnostic technologies, with digital PCR technology being a key area of focus. We are well aware that in an era where medical diagnosis increasingly pursues precision, digital PCR technology, with its unique advantages, is expected to be the “golden key” to solving many medical problems.

Authoritative Recognition: The Driving Force for Forging Ahead

This certification is of great significance for both the digital PCR industry and TargetingOne. It marks the entry of the digital PCR industry into a new era of clinical applications and indicates that TargetingOne has been highly recognized in all aspects, including product research and development, manufacturing, quality control, and clinical application value. Successfully passing the strict review process of the NMPA proves that the TargetingOne D50 automatic digital PCR instrument is at the forefront of the industry and has the strength to play a leading role in the medical field.
We look forward to in – depth cooperation with various medical institutions, IVD enterprises, third – party testing agencies, pharmaceutical companies, and other partners to jointly explore the application potential of digital PCR technology in clinical diagnosis, disease monitoring, drug research and development, and other fields. We aim to make this advanced technology benefit a large number of patients and contribute to the development of precision medicine.

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.