FUU-JEN TSAI, Vice President of China Medical University
LDTs nowadays have evolved and proliferated significantly in precision medicine, shedding further light on disease management and leading to actionable interventions. With advances in technology and new business models, the LDT oversights are being discussed worldwide. LDTs have direct effect on the outcomes of patients care; therefore, patient safety must always be the top priority. The project not only aims to review the regulatory oversights and governance in different countries but also develop a feasible route to market for the LDT products.
In addition, the emergence of next-generation sequencing (NGS) technology shortens the lengthy process of rare disease diagnosis, and makes the vulnerable group access the appropriate therapy in time. As NGS is widely adopted in the clinical practices, it is essential to develop appropriate policy recommendations to ensure the safety and effectives of the genome sequencing. Moreover, the project will have stakeholder involvement to identify technical, ethical, legal, social, economic, and reimbursement issues in Taiwan.