On July 8, 2025, Shanghai Epiprobe Biotechnology Co., Ltd. (hereinafter referred to as ” Epiprobe Bio”) ushered in an important milestone – its independently developed PCDHGB7 gene methylation detection kit (PCR-fluorescent probe method) (trade name: Gong Yi’an®) was officially approved for marketing by the National Medical Products Administration (NMPA) (Registration Certificate No.: National Medical Device Registration No. 20253401308), which is the world’s first certificate for a Class III medical device for methylation detection without bisulfite treatment.
Innovation leads the way to fill the gap
As the world’s first Class III medical device cervical cancer methylation detection product based on methylation-sensitive restriction endonuclease technology without bisulfite treatment, the Epiprobe Bio Gong Yi An® Kit is suitable for cervical cancer detection and helps accelerate the elimination of cervical cancer. This original innovative product will bring a new solution to the prevention and control of cervical cancer with its breakthrough detection efficiency and clinical value.
Core advantages subvert tradition
Proprietary targets, global patent layout
The target of Gong Yian® kit, PCDHGB7 , is a disruptive innovative marker obtained by Professor Yu Wenqiang, founder and chief scientist of Epiprobe Biology, and his team through the self-developed guided positioning sequencing technology (GPS). As the first marker of Epiprobe , this target has applied for a global patent. The detection and industrial application project based on this type of innovative target has won the highest award in the final of the National Disruptive Technology Innovation Competition hosted by the Ministry of Science and Technology – the Winning Award.
Bisulfite-free treatment method, a tool for reducing costs and increasing efficiency
As the world’s first Class III medical device methylation detection kit developed based on restriction endonuclease technology without bisulfite treatment, the Epiprobe Bio Gong Yi’an® kit does not require bisulfite treatment during the detection process. After nucleic acid extraction, the test can be completed directly on the machine in one tube. The latest version of the “Expert Consensus on Tumor DNA Methylation Marker Detection and Clinical Application (2024 Edition)” clearly points out that the enzyme digestion method is the direction with application development potential for DNA methylation detection in the future. Through enzyme digestion technology, Gong Yi’an® has greatly shortened the detection process and detection time, effectively reduced the detection cost, and improved the detection efficiency; on the other hand, because the enzyme digestion method is relatively mild in treating DNA and does not require the conversion of DNA sequences, the stability and repeatability of methylation detection will be significantly improved.
Continuous monitoring, full quantification
In order to better solve the pain points of clinical applications, Epiprobe Bio has accumulated and built a deep AI algorithm model of more than 100,000+ sample cohorts through double-blind verification in the application of PCDHGB7 gene methylation in cervical cancer. At the same time, it has developed gene methylation detection and analysis software and has obtained a Class II medical device registration certificate approved by NMPA. Through the use of analysis software, the results of cervical cancer methylation detection can be output as a numerical value of 0 to 100 points, thereby achieving accurate risk grading management. At the same time, during continuous monitoring, the trend of changes in numerical values can also be used to evaluate the changing trend of the subject’s cervical cancer risk, and dynamic quantitative monitoring of the entire course of the disease can be achieved, thereby providing effective guidance for the subject’s early screening, efficacy evaluation or recurrence monitoring and other scenarios.
Evidence-based support for authoritative consensus
At present, Epiprobe Biotech has been deeply engaged in scientific research cooperation with many authoritative tertiary hospitals in China, and its academic achievements continue to lead the industry. It has published many SCI papers with the highest impact factor of 40.8. Among them, the related projects of Gong Yi’an® test kit detection technology have published two SCI papers with impact factors of 11.5 and 11.8 respectively, demonstrating its academic leadership in the field of molecular diagnosis of cervical cancer. At the same time, the Gong Yi’an® test kit also played a significant role in the Epiprobe Biotech’s 100,000 cervical cancer gene methylation screening scientific research cohort study of “Eliminate Cervical Cancer and Build a Healthy China Dream”, which fully verified its effectiveness in the real world and revealed its key role in improving the effectiveness of grassroots screening. In addition, the application of Gong Yi’an® in multiple scenarios such as cervical cancer screening and auxiliary diagnosis has been written into the latest version of the “Expert Consensus on Tumor DNA Methylation Marker Detection and Clinical Application (2024 Edition)” and has been strongly recommended.
The approval of Gong Yi An® for marketing is of groundbreaking significance. It is an important milestone for Epiprobe Biotech to deepen its research on epigenetic methylation technology, and it is also a powerful implementation of its mission of “keeping everyone away from cancer”. From technology research and development to clinical verification, Epiprobe Biotech has joined forces with multiple parties to build a full-chain evidence-based system covering screening, diagnosis, and follow-up to ensure the reliability and stability of the product from laboratory to clinic. In the future, Epiprobe Biotech Gong Yi An® will benefit more female friends and safeguard their health. Let us work together to achieve the great goal of eliminating cervical cancer as soon as possible!
About Epiprobe Biotech
Epiprobe Bio is a pan-cancer early screening and diagnosis company that focuses on tumor molecular diagnosis and precision medicine industry. It is mainly engaged in the research, development, production and sales of DNA methylation detection related product technologies. Relying on more than 30 years of scientific research and exploration by an outstanding team of epigenetic experts and relying on deep academic accumulation, by establishing a unique whole-genome DNA methylation detection method GPS technology covering 96% of the genome methylation region, it has discovered a subversive tumor common DNA methylation marker TAGMe® with independent intellectual property rights. At present, the pan-cancer marker has a total of 88 domestic and international patents, and has won the FDA breakthrough medical device certification/EU CE certification and the National Disruptive Technology Innovation Competition Finals of the Ministry of Science and Technology. The pan-cancer marker has been verified in more than 170,000 clinical double-blind samples of 25 tumors and 13 tumor sample types in more than 40 top tertiary hospitals in China, and the overall compliance rate of tissue samples exceeds 90%. Epiprobe Biotech is deeply engaged in the field of cancer screening. Adhering to the mission of “keeping everyone away from cancer”, it is committed to the early detection, early diagnosis and early treatment of cancer, taking it as its mission to improve the survival rate of cancer patients, and intelligently manufacturing new technology products that lead the times, just to eliminate cancer in its infancy and achieve health for all!
Post time: Jul-17-2025