Former FDA Expert Dr. Yunfu Hu Appointed Chief Medical Officer at Genetron Health

Today, Genetron Holdings Limited announced that Dr. Hu Yunfu, a former senior expert at the U.S. Food and Drug Administration (FDA), has been appointed as the company’s Chief Medical Officer. He will lead the company’s regulatory affairs for in vitro diagnostic medical device registration and its drug development services business.

Dr. Hu has over twenty years of experience in corporate management and government regulation within the medical device and pharmaceutical R&D sectors. During his tenure at the FDA, he led teams responsible for the review and oversight of cancer in vitro diagnostic (IVD) products and laboratory-developed tests (LDTs). His landmark approvals include: the first NGS-based LDT companion diagnostic service (Foundation Medicine’s FoundationFocus CDxBRCA), the first NGS-based companion diagnostic kit (Thermo Fisher’s Oncomine Dx Target Test), NGS-based comprehensive tumor panel testing services (Memorial Sloan Kettering Cancer Center’s MSK-IMPACT and Foundation Medicine’s FoundationOne CDx), the first liquid biopsy companion diagnostic kit for non-small cell lung cancer (NSCLC) (Roche’s Cobas EGFR Mutation Test v2), and the only two cancer early screening products currently approved by the FDA (Exact Sciences’ Cologuard and Epigenomics’ Epi ProColon).

He led his team to receive more than ten FDA Commissioner’s Commendations for their outstanding contributions to the first-time approvals of multiple innovative products. Prior to joining the FDA, he had over a decade of product development experience at world-class diagnostics and pharmaceutical companies, where he led teams to achieve remarkable success in precision medicine research, oncology biomarker development, diagnostic product development, and regulatory registration.

Mr. Wang Sizhen, Co-founder and CEO of Genetron Health, stated: “In the fields of cancer molecular diagnostics and drug development, Dr. Hu possesses both outstanding regulatory expertise and solid industry experience, making him a rare multidisciplinary expert in the global biopharmaceutical sector. Dr. Hu’s arrival has brought to Genetron Health’s molecular diagnostics business internationally advanced, systematic experience encompassing technology R&D, product design, clinical approval, and regulatory compliance. This will help Genetron Health and the broader industry promote the high-quality and efficient clinical application of more innovative technologies.”

Dr. Hu Yunfu stated: “China possesses unique advantages in clinical data within the field of cancer precision medicine, and in recent years, a number of world-class enterprises, technologies, and products have emerged. I was deeply impressed by the international vision and forward-looking insights of Genetron Holdings Limited’s management team, particularly by its innovative technologies and the sustained innovation capabilities underpinning them, which convinced me of Genetron’s immense development potential. It is a great honor to join Genetron Holdings Limited, where I will help accelerate the global clinical translation and application of its innovative technologies and build a global one-stop service platform for drug development, striving to enable China’s high-quality biotechnology services to benefit the world.”

Genetron Holdings Limited is a leading and rapidly growing precision oncology company in China, dedicated to providing one-stop molecular diagnostic solutions for multiple application scenarios, including cancer diagnosis and monitoring, early screening, and drug development services. Genetron serves over 400 hospitals, dozens of pharmaceutical companies, and research institutions in China, and has established a large-scale genomic database.

In the field of diagnosis and monitoring, Genetron Holdings Limited provides comprehensive genomic testing services and products, covering eight of the top ten most prevalent cancers in China, with capabilities for both tissue-based testing and liquid biopsy. Leveraging proprietary technologies such as its “One-Step” method, Genetron has developed a comprehensive portfolio of in vitro diagnostic (IVD) products based on NGS, dPCR, and qPCR platforms. Seven of its instruments and assay kits have been approved by the National Medical Products Administration (NMPA) of China for clinical use. In the frontier area of early cancer screening, Genetron has independently developed the advanced Mutation Capsule technology, which enables simultaneous detection of mutations and methylation.

Genetron Holdings Limited has launched large-scale prospective cohort studies in the field of early liver cancer screening and has been approved to join several national key special projects led by the Ministry of Science and Technology, focusing on liver cancer, lung cancer, and gastrointestinal cancers. In the field of drug development services, Genetron has established strategic collaborations with dozens of domestic and international pharmaceutical companies, meeting their needs in early-stage drug development and target screening, clinical trial testing and patient enrollment, as well as the registration, development, and commercialization of companion diagnostics (CDx).

Genetron Holdings Limited operates dual R&D centers in China and the United States, two medical device manufacturing bases certified under ISO 13485:2016 and ISO 9001:2015 standards, and five clinical laboratories located in Beijing (dual-certified by CAP and CLIA), Shanghai, Hangzhou, Chongqing, and Guangzhou. Genetron’s scientists are at the forefront of cancer genomics academia, leading a top-tier R&D team to build world-class research capabilities, and have published dozens of papers in prestigious global academic journals such as Nature Genetics, Nature Communications, Cell Research, and PNAS.