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Major Breakthrough! TargetingOne's Lung Cancer EGFR Liquid Biopsy Digital PCR Kit Obtains Class III Registration Certificate! On September 2, 2024, the "Human EGFR Gene Mutation Detection Kit (Digital PCR Method)" developed by TargetingOne was approved by the National Medical Products Administration (NMPA). This is another digital PCR diagnostic reagent launched by TargetingOne after its nucleic acid detection reagent for COVID - 19 based on digital PCR technology was approved in 2022. This reagent is used for the companion diagnosis of lung cancer EGFR gene liquid biopsy, representing a significant breakthrough in the research, development, and application of the high - [...]

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 [...]

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 [...]

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 [...]

Nucleic acid extraction in molecular diagnostics Molecular diagnosis refers to the application of molecular biology methods outside the human body to detect changes in the structure or expression levels of genetic material in the patient's body, and to obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.) in order to determine disease or body function. One of the key steps in detecting human samples is the extraction and purification of nucleic acids (DNA and RNA) from the samples, the quality of which directly determines the validity and accuracy of the test results. ​ As a leader in [...]