On April 2, 2025, the "Human Cholangiocarcinoma 5 Gene Mutation Detection Kit" independently developed by Academician Fan Jia's team from Zhongshan Hospital Fudan University and Dunwill Medical was officially registered with the Shanghai Medical Products Administration, marking the first international medical institution to independently develop an IVD kit (HDT) for precise molecular diagnosis of cholangiocarcinoma patients. This innovative achievement not only fills the gap in the field of molecular diagnosis of cholangiocarcinoma, but also highlights China's historic leap from "following" to "leading" in the field of precision medicine for tumors.

In primary liver cancer, the incidence rate of intrahepatic cholangiocarcinoma is second only to hepatocellular carcinoma, and is known for its high invasiveness and insidious incidence. At present, there is a lack of early and effective diagnostic methods for cholangiocarcinoma, and existing detection schemes cannot cover targeted drug genes related to cholangiocarcinoma in one test. Therefore, it is urgent to develop effective and precise detection and diagnostic technologies and methods.

The "Human Cholangiocarcinoma 5 Gene Mutation Detection Kit" developed in collaboration between Zhongshan Hospital Fudan University and Dunwill Medical, innovatively uses NGS technology that combines DNA and RNA detection to achieve synchronous detection of DNA mutations and RNA fusion mutations in five key genes of cholangiocarcinoma patients. Compared to methods such as IHC, FISH, PCR, etc., NGS can cover all targets of cholangiocarcinoma. Clinical research at Zhongshan Hospital has found that compared to traditional single gene testing methods, the overall detection rate has increased by 86%, and the average testing time has been shortened from 17.6 days to 5 days. In addition, the launch of the "Multi-center Study on Methodological Comparison of FGFR2 Gene Fusion Rearrangement Detection in Intrahepatic Cholangiocarcinoma" project will also provide more sufficient evidence and support for its clinical application.

Based on years of deep accumulation in integrating omics transformation research, unique multi-platform integration capabilities, and industry transformation experience in original diagnostic products outside of the target object. Focusing on important clinical issues and core clinical pain points, Dunwill Medical adopts an innovative industry-academic-research cooperation model led by medical institutions for technology research and development, and enterprise guarantees for production and product quality. It has successfully achieved efficient transformation from laboratory to clinical products and developed multiple original clinical grade IVD products with independent intellectual property rights. To solve the bottleneck problem of clinical innovation, Dunwill has provided a closed-loop solution for the entire process of "Accurate identification of clinical needs - IVD product Development & Biomarker Research and Development - Lean Manufacture Capabilities - Clinical Application &  Registration ", truly connecting the entire chain of "Medical-R&D-Manufacture", seamlessly integrating it, and continuously empowering clinical transformation.

As a local innovation benchmark enterprise in Shanghai, Dunwill Medical and Zhongshan Hospital continued to deepen their strategic cooperation, and successfully completed the transformation of a number of innovation results through a strong alliance, giving play to their respective strengths. In November last year, Dunwill Medical and Zhongshan Hospital signed a strategic cooperation agreement on clinical research cooperation, achievement transformation, and new technology application in the "Shanghai International Medical Science and Technology Innovation Center · Spatiotemporal Omics Precision Diagnosis and Treatment Excellence Innovation Center" jointly established by Dunwill Medical and Zhongshan Hospital. Based on the "Medical, Academia, Research, Production, and Government" five force linkage innovation paradigm, both sides will deeply integrate Zhongshan Hospital's clinical resource advantages as a national medical center with Dunwill Medical's innovative strength in the fields of spatiotemporal multi omics technology and original research biomarker transformation. Through joint technology research and patent sharing mechanisms, they will accelerate the transformation of major scientific research achievements into clinical applications, providing new impetus for the development of precision diagnosis and treatment in China.

In the future, Dunwill Medical will continue to work with clinical experts to further deepen cooperation, enhance research and development and clinical translation capabilities, take innovation as the guide, and enable more breakthrough achievements to benefit more patients, jointly creating a beautiful future of precision diagnosis and treatment.