Major Breakthrough | TargetingOne’s Hepatitis B DNA Quantitative Detection Digital PCR Reagent Obtains Class III Registration Certificate!

TargetingOne Technology (Beijing) Co., Ltd., a wholly – owned subsidiary of TargetingOne Co., Ltd., had its “Hepatitis B Virus (HBV) Nucleic Acid Detection Kit (Digital PCR Method)” approved as a Class III medical device by the National Medical Products Administration (NMPA). This is another blockbuster Class III diagnostic reagent based on digital PCR technology launched by TargetingOne, following the approval of its nucleic acid detection reagents for COVID – 19 and blood EGFR mutation detection. This kit can directly conduct in – vitro quantitative detection of hepatitis B virus (HBV) DNA without relying on a standard curve. It has high sensitivity and precise quantification, with both the limit of detection and the limit of quantitation as low as 5 IU/mL, meeting the requirements of the latest domestic and international “Guidelines for the Diagnosis and Treatment of Chronic Hepatitis B”. It contributes to the realization of the World Health Organization’s (WHO) strategic goal of eliminating the harm of hepatitis B by 2030. This approval represents another significant breakthrough in the research, development, and application of the high – end digital PCR technology in China!

Ultra – sensitive HBV DNA Quantitative Detection Is Crucial for the Clinical Cure of Hepatitis B

China bears the heaviest burden of hepatitis B globally. Public data shows that in 2024, the number of HBV carriers in China reached as high as 75 million. Early detection, diagnosis, and treatment are the keys to reducing the occurrence of severe liver diseases. The “Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)” proposes a “Treat All” intervention strategy, suggesting the relaxation of treatment indications and a more proactive approach to treating chronic hepatitis B patients. As long as HBV DNA can be detected, combined with other indicators, treatment can be initiated. Ultra – sensitive quantitative detection of HBV DNA is of great significance in the initial stage of the clinical cure of hepatitis B. It can sensitively diagnose occult HBV infection, prevent viral re – activation, accurately determine the initiation time of antiviral treatment, and precisely manage low – level viremia.

Advantages of Ultra – sensitive HBV DNA Quantitative Detection Based on Digital PCR

Digital PCR is one of the most remarkable innovations in the field of life sciences and has two significant advantages in HBV DNA detection:

 

  1. Ultra – high sensitivity: It is ultrasensitive. Compared with fluorescence – based PCR, it has superior single – molecule – level detection performance. Even if the sample contains only trace amounts of nucleic acid templates, it can be efficiently and stably detected. This can help identify hepatitis B patients who need to initiate antiviral treatment at an early stage and effectively improve the diagnostic rates of occult hepatitis B patients (OBI) and low – level viremia patients (LLV), truly meeting the high – sensitivity requirements for the clinical cure of hepatitis B.
  2. Ultra – precise quantification: It enables precise quantification. Without the need for a standard curve, it can directly read the number of target DNA molecules in the original sample. Compared with fluorescence – based PCR, it can more intuitively and accurately track the changes in the nucleic acid load of the hepatitis B virus, assisting clinicians in formulating precise treatment plans.

 

The “Hepatitis B Virus (HBV) Nucleic Acid Detection Kit (Digital PCR Method)” approved for TargetingOne this time, with its two outstanding technical advantages and excellent clinical performance, can better meet the detection requirements for the clinical treatment of hepatitis B. The application of this kit will promote the improvement of the diagnostic and treatment rates of hepatitis B and strongly advance the progress of the clinical cure of hepatitis B.

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.