Our Team
Yun-Fu Hu, Ph.D., RAC, ASQ CQA
Co-Founder & Managing Partner
Donna Roscoe, Ph.D.
Co-Founder & Managing Partner
Xueying (Sharon) Liang, M.D., Ph.D., RAC
Co-Founder & Managing Partner
Yun-Fu Hu, Ph.D., RAC, ASQ CQA
Co-Founder & Managing Partner
Dr. Yun-Fu Hu is a regulatory science and precision medicine leader with more than two decades of experience spanning FDA leadership and senior roles in industry.
Before co-founding YDX Group, Dr. Hu founded Encore Biotech LLC and served as Chief Medical Officer of Genetron Health. He spent 11 years at the U.S. Food and Drug Administration, where he served as Deputy Director of the Division of Molecular Genetics and Pathology in CDRH’s OHT7/Office of In Vitro Diagnostics. He also contributed to the formation of the FDA Oncology Center of Excellence and served as its first Acting Associate Director of In Vitro Diagnostics.
At FDA, Dr. Hu led multidisciplinary teams overseeing premarket review and postmarket activities across advanced diagnostics and enabling technologies, including companion diagnostics, tumor profiling, liquid biopsy, digital pathology, and AI-enabled devices. His group received multiple FDA and Center-level awards in recognition of scientific and regulatory excellence.
Earlier in his career, Dr. Hu held roles in diagnostics and pharmaceutical development at Metabolon, GlaxoSmithKline, and Becton Dickinson Diagnostic Systems.
Donna Roscoe, Ph.D.
Co-Founder & Managing Partner
Dr. Donna Roscoe is a regulatory leader with nearly two decades of experience at the U.S. Food and Drug Administration, bringing deep expertise in the development, evaluation, and regulatory oversight of in vitro diagnostic devices (IVDs).
During her tenure at FDA, Dr. Roscoe held multiple senior leadership roles within the Office of In Vitro Diagnostic Devices, including Senior Reviewer in the Division of Immunology and Hematology and Branch Chief, Deputy Division Director, and Acting Division Director in the Division of Molecular Genetics and Pathology. In these roles, she was responsible for regulatory review and decision-making for IVDs across oncology, companion diagnostics, and hereditary genetic testing, and played a key role in establishing policies that advanced the regulation of precision medicine diagnostics.
Prior to joining FDA, Dr. Roscoe worked in clinical research and regulatory support roles at several contract research organizations and at the National Center for Biotechnology Information (NCBI). She completed postdoctoral training in the Laboratory of Molecular Biology at the National Cancer Institute (NCI), National Institutes of Health, with a focus on clinical cancer research.
Dr. Roscoe currently serves as a senior advisor to a pharmaceutical company, providing strategic regulatory insight to support diagnostic and precision medicine programs.
Xueying (Sharon) Liang, M.D., Ph.D., RAC
Co-Founder & Managing Partner
Dr. Xueying (Sharon) Liang is a physician-scientist and human geneticist with 20 years of experience in regulatory strategy, diagnostic development, and global health authority engagement.
Prior to co-founding YDX Group, Dr. Liang served as Executive Director and Head of Precision Medicine and Digital Health in Global Regulatory Science at Bristol Myers Squibb, leading global regulatory strategy and execution for precision medicine and digital health products across the portfolio. She also held leadership roles at Burning Rock Dx, where she oversaw regulatory, quality, and operations supporting companion diagnostics and clinical trial assay services, and at GRAIL, where she led FDA PMA and Q-submission activities for a multi-cancer early detection test.
Earlier, Dr. Liang served as a senior reviewer and team leader at FDA CDRH, supporting regulatory review and policy development in areas including NGS and bioinformatics pipelines, direct-to-consumer testing, companion diagnostics, cancer screening, digital pathology, and emerging technologies. She also contributed to FDA initiatives supporting quality modernization and evolving regulatory frameworks.
Dr. Liang holds a PhD in Human Genetics and an MS in Applied Statistics from Vanderbilt University, completed postdoctoral training in cancer research at the National Cancer Institute, and was a Commissioner’s Fellow at FDA. She also received her MD from Tianjin Medical University.