Abstract:

Laboratory developed tests (LDTs) are playing an increasingly important role in personalized medicine; however, it is also becoming more complex, high-risk, and full of problems and pitfalls to be solved. The regulation of LDTs have been captured much more attention in foreign countries, especially in the United State, after its decades of evolution, and newly rules are draw up. The clinical applications of LDTs are just around the corner in China,even though it is not qualified currently. An ideal model of regulation should include fairness, risk-based regulatory program, gradually supervision, proficiency testing, clinical effectiveness and practicality as well as Emergency Use Authorization. LDTs provide an opportunity not only for developing laboratory medicine but also for bettering the clinical service; while the quality control and management system of LDTs should be established and improved gradually.

Key words: Laboratory developed test, Quality management, Medical laboratory