Genetron Holdings Limited ("Genetron Health"), a China-based precision oncology company, today announced the appointment of Dr. Yun-Fu Hu as Chief Medical Officer. A former deputy director with the US Food and Drug Administration (FDA), Dr. Hu will be tasked to steer the company forward in its in vitro diagnostic (IVD) devices registration and regulatory affairs as well as bio-pharmaceutical services business.
Dr. Hu has over two decades of experience in regulatory and managerial capacities related to medical devices and pharmaceutical industries. During his tenure at FDA, he has led a team of staff in premarket reviews and post-market compliance of IVD products and laboratory-developed tests (LDTs) for genetic testing, molecular cancer diagnostics, companion diagnostics, radiodosimetry, digital pathology and artificial intelligence devices. Some of his notable authorizations include: the first next generation sequencing (NGS)-based LDT as companion diagnostics (CDx) (Foundation Medicine FoundationFocus CDxBRCA); the first NGS-based CDx kit (ThermoFisher Oncomine Dx Target Test); the first NGS-based LDT for tumor profiling (MSK-IMPACT) and later on FoundationOne CDx); the first liquid biopsy test for NSCLC (Roche Cobas EGFR Mutation Test v2); and FDA’s only two approved cancer screening tests in the last decade (Exact Sciences’ Cologuard and Epigenomics’ Epi ProColon). Dr. Hu and his team have also won over 10 FDA-level group awards for outstanding contributions in FDA authorization of many such first-of-its-kind devices.
Prior to joining FDA, Dr. Hu has more than 10 years of product development experience in diagnostic and pharmaceutical industries, leading his teams to achieve outstanding results in biomarker discovery and diagnostic development.
Sizhen Wang, Genetron Health’s co-founder and CEO, said, "Dr. Hu’s caliber and depth of experience in molecular cancer diagnostics and pharmaceutical R&D is nothing short of exceptional. Hailed with outstanding regulatory background and solid industry experience, he is a perfect hybrid talent in the global biopharmaceutical field. With Dr. Hu joining our leadership team, he will value-add to our molecular diagnostic business with international best practices in technical R&D, product design, clinical approval and policy and regulatory matters. I believe he will be an asset to Genetron Health and the industry in driving high quality and high efficiency clinical adoption of more innovative technologies."
Dr. Hu said, "China has a unique advantage in precision oncology clinical data. We have witnessed the emergence of many outstanding companies, related technologies and products in recent years. I am truly impressed with the global vision shown by the leadership at Genetron Health. I believe Genetron has massive growth potential, driven by the company’s continuous innovation capabilities. I am delighted to be part of this team and I look forward to assisting the clinical adoption of Genetron’s innovative technologies and the establishment of a global one-stop bio-pharmaceutical service platform. It is our hope to bring high quality China biotechnology to the world."
About Genetron Health
Genetron Health is a leading and fast-growing precision oncology company in China that aims to provide one-stop genomic profiling solutions for multiple scenarios covering early screening, diagnosis and monitoring, and biopharmaceutical services. The company collaborates with over 400 hospitals and dozens of biopharmaceutical companies and research institutions, and has developed a large proprietary genomic database.
Genetron Health has established R&D centers in both the United States and China, two manufacturing facilities with both ISO 13485:2016 certification and ISO 9001 2015 certification in China and five clinical laboratories in Beijing (CLIA accreditation and CAP certification), Shanghai, Hangzhou, Chongqing and Guangzhou. The R&D capacities of Genetron Health are supported by a best-in-class research and development team led by scientists at the forefront of cancer genomics research. The company has published many research papers in highly influential worldwide peer-reviewed scientific journals, such as Nature Genetics, Nature Communications, Cell Research and PNAS. For more information, please visit www.genetronhealth.com.