Genetron Holdings Limited 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.