Analyze the current situation and management prospects of laboratory-developed tests（LDTs）.

This study compares and analyzes the management strategies of LDTs domestically and internationally, encompassing quality control, accuracy, safety, intellectual property protection, economic benefits, career development, and talent training.

To address the management issues associated with LDTs, researchers need to focus on clinical management, funding management, patent management, and operational management. In terms of clinical management, researchers should emphasize the application of LDTs in clinical practice to ensure their practical value for clinicians. Regarding funding management, researchers should ensure compliance with LDTs projects for sustainable development under clinical supervision. With respect to patent management, attention should be given to marketization and patent transfer to safeguard the rights and interests of all parties involved. In operational management aspects; innovation can be stimulated through market competition mechanisms while establishing collaborative platforms for obtaining sufficient clinical data. For daily operations, adherence to relevant provisions such as ISO17511, ISO15189 and CAP is recommended to standardize quality assurance procedures and enhance reliability and accuracy of LDTs.

Furthermore, the future will witness continuous improvement in the regulation and governance surrounding LDTs by bridging barriers between researchers and markets effectively through system reforms that stimulate research innovation momentum leading towards increased production of in vitro diagnostics (IVD) products benefiting patients.