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 – end digital PCR technology in China!
Compared with fluorescence quantitative PCR (qPCR), digital PCR has higher sensitivity and can perform absolute quantification. It is especially suitable for detecting rare mutations in complex backgrounds, and its technical advantages have been widely recognized. As the first companion diagnosis product for lung cancer liquid biopsy based on digital PCR technology, this kit provides an innovative solution for precise diagnosis and treatment of lung cancer, with four major advantages: ultra – sensitivity, precision, speed, and compliance.

Liquid Biopsy: An Important Means for Precise Diagnosis and Treatment of Lung Cancer

The liquid biopsy technology based on circulating tumor DNA (ctDNA) provides a convenient, rapid, and precise method for detecting driver genes. It overcomes the limitations of traditional tissue biopsy, such as invasiveness, difficulty in repeated acquisition of tumor tissue, and tumor heterogeneity. Liquid biopsy has the characteristics of easy sample collection, minimal invasiveness, dynamic monitoring, and being unaffected by tumor heterogeneity. It can help doctors better understand the gene mutation status of lung cancer patients, thereby formulating more precise treatment plans and improving treatment effectiveness. Therefore, liquid biopsy is regarded as an important means for “individualized precision medicine” in lung cancer.

Advantages of Lung Cancer EGFR Liquid Biopsy Based on Digital PCR

Digital PCR is one of the most remarkable innovations in the field of life sciences, with three major technical advantages: First, it is ultra – sensitive, featuring superior single – molecule – level detection performance. Even if there is only a trace amount of ctDNA in the blood, it can be efficiently detected, meeting the high – sensitivity requirements of liquid biopsy. Second, it enables absolute quantification. Digital PCR can directly read the number of target DNA molecules in the original sample without the need for a standard curve, allowing for more intuitive and effective dynamic tracking of ctDNA changes. Third, it is fast, with results available in 3 hours, facilitating rapid clinical decision – making.

 

The registration clinical trial of TargetingOne’s “Human EGFR Gene Mutation Detection Kit (Digital PCR Method)” has accumulated the testing of plasma samples from over 1,000 non – small cell lung cancer patients, with a total coincidence rate as high as 96.61%. It has also completed the testing of approximately 300 pairs of homologous plasma and tissue samples. The analysis results show that the product has good consistency with the original research reagent. The clinical trial has also verified the significance of companion diagnosis for erlotinib and osimertinib.

 

The “Human EGFR Gene Mutation Detection Kit (Digital PCR Method)” approved for TargetingOne this time, with its three technical advantages and excellent clinical sensitivity and specificity, effectively addresses the pain points of current liquid biopsy and opens a new chapter in molecular detection.

Compliance for Hospital Use: The Key to Liquid Biopsy

Undoubtedly, compliance is the main theme of the current medical market. The approval of the Class III certificate for the EGFR liquid biopsy kit independently developed by TargetingOne this time provides a strong guarantee for compliant clinical use in hospitals. It is a general trend for hospitals to independently carry out tumor molecular detection. Digital PCR products have the technical characteristics of easy implementation and fast operation, which can help hospitals carry out in – hospital tumor detection in a compliant and convenient manner. The advancement and important value of digital PCR technology have become a consensus in the industry. It is bound to become a key technical platform for clinical molecular diagnosis and will witness rapid growth.

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.