Passion. Experience. Diligence.
YDX Group is founded by Dr. Yun-Fu Hu, Dr. Donna Roscoe, and Dr. Xueying (Sharon) Liang — former FDA leaders who met while working in the Division of Molecular Genetics and Pathology (DMGP), the review group entrusted to regulate in vitro diagnostic devices (IVDs) and laboratory-developed tests (LDTs) for:
Genetic testing
Molecular cancer diagnostics (e.g., liquid biopsy, cancer screening, monitoring, minimal residual disease)
Companion / complementary diagnostics
Digital pathology
Artificial intelligence devices
The three founders worked together at FDA for more than a decade and served in senior leadership roles within DMGP and its predecessor division, including branch-level and division-level leadership supporting critical regulatory review and policy development in precision medicine and emerging diagnostic technologies.
We believe that successful regulatory strategy is built on sound science, transparent communication, and trusted relationships. We share a strong desire to use our scientific, technical, and regulatory expertise to help companies advance medical innovation and transform ideas into breakthrough solutions that redefine healthcare and improve lives globally.
Why choose YDX
FDA experience that matters
Our advisors have held senior positions within the agency, evaluating diagnostics, devices, and digital health products.
Scientific and regulatory depth
We translate complex evidence requirements into clear, achievable plans.
Practical, actionable guidance
We focus on what moves development forward, not generic checklists.
Transparent, collaborative partnerships
You get direct access to experts who understand your challenges and work with you closely to solve them.
Uncompromising integrity and clarity
Trusted judgment for high-stakes decisions.
How We Work
We structure our support to fit each client’s needs — from early concept discussions to submission planning and FDA interaction.
Collaborative, hands-on engagements
Clear, actionable recommendations
Tailored support for diagnostics, devices, and digital health innovation
At YDX, every engagement is led by senior experts who will help you navigate the complex regulatory landscapes for your success.