In the fragrant April, all things await new. Adhering to the concept of "innovation, transformation, cooperation, and sharing", the three-day event——Chinese Academic Conference on Tumor Biomarker was grandly held in Nanjing. This conference closely focuses on basic research, cutting-edge technologies, clinical applications, and industrial development of new tumor biomarkers and related fields, creating more than 40 themed forums and special activities, fully showcasing the latest research achievements in tumor biomarkers and related fields.

With the development of modern medicine, exploring and developing new tumor markers and detection technologies is an important issue in solving the bottleneck of clinical tumor diagnosis. At the Tumor Markers Technology Transformation Forum held on the afternoon of April 20th, Professor Ji Yuan, Director of the Molecular Pathology Center of Zhongshan Hospital Affiliated to Fudan University, presented a brilliant report on “The development practice of ‘self-developed’ reagents in medical institutions - the development process of a human cholangiocarcinoma 14 gene mutation detection kit." The report shared the development process and important value of self-developed reagents for cholangiocarcinoma from multiple dimensions, including clinical status, molecular typing, preliminary and multicenter clinical research, development process, and quality system construction.

Director Ji pointed out that“self-developed reagents”of medical institutions can effectively assist innovative technologies in their clinical application. In primary liver cancer, the incidence rate of intrahepatic cholangiocarcinoma is only second to that of hepatocellular carcinoma. Because of the atypical clinical symptoms, most patients were diagnosed as late stage. According to the consensus on the diagnosis and treatment of intrahepatic cholangiocarcinoma in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer, molecular diagnosis is a new demand in precision medicine. The molecular map of intrahepatic cholangiocarcinoma is clear, and multiple targets have already been approved and have drugs in clinical trials. However, currently there is a lack of early and effective diagnostic methods for cholangiocarcinoma, and existing detection schemes cannot detect genes related to targeted drugs in cholangiocarcinoma at once. Therefore, there is an urgent need to develop effective and precise detection and diagnostic technologies and methods.

Director Ji introduced the human cholangiocarcinoma 14 gene mutation detection kit developed in collaboration between Zhongshan Hospital affiliated with Fudan University and Dunwill Medical. The kit is a DNA+RNA detection kit that covers FGFR fusion, IDH1/2, KRAS, and BRAF mutations. Compared to methods such as IHC, FISH, and PCR, NGS can cover all targets of cholangiocarcinoma. A clinical study at Zhongshan Hospital found that in intrahepatic cholangiocarcinoma, the detection rate of FGFR2 fusion gene using this reagent kit was 11.1% (RNA level fusion), higher than the 9.6% (DNA level fusion) in the FIGHT-202 study. The relevant research has been listed as one of the first HDT projects approved and filed by the National Medical Products Administration (NMPA), and has obtained a national invention patent (application number: 202311675544.3). In addition, the multicenter study comparing the detection methods of FGFR2 gene fusion rearrangement in intrahepatic cholangiocarcinoma was launched at the end of last year, which will provide more sufficient evidence and support for its clinical application.

Honorary Awards

This innovative technology——the Human Cholangiocarcinoma 14 Gene Mutation Detection Kit (Reversible End Termination Sequencing), also won the second prize in the selection of "2023 Tumor Markers Innovative Technology Products" at the Chinese Academic Conference on Tumor Biomarker (CCTB), marking its innovation and advantages being professionally recognized. This honor is not only a recognition of Dunwill's past efforts, but also an encouragement for our continuous exploration in the future.

This conference presented multiple high-level and international academic feasts, bringing collision of ideas and sparks of innovation to everyone. With the continuous introduction of more and more new ideas and methods, as well as the influx of emerging technologies, we are full of hope for the future of precise diagnosis and treatment of tumors. On the exploration path of precise diagnosis and treatment of tumors, it is necessary not only to engage in Speculative thinking and seeking truth, but also to closely integrate basic research with clinical practice.

In the future, Dunwill Medical will continue to collaborate with clinical experts to explore more innovative research and transformation of tumor biomarkers, as well as cutting-edge tumor diagnosis technologies, to promote high-quality development of the industry and enable precise diagnosis and treatment to benefit more patients.