Laboratory Developed Tests (LDTs)

Laboratory Developed Tests (LDTs) are diagnostic or screening tests created and used within a specific laboratory, rather than being commercially manufactured for widespread sale. Designed to meet particular clinical needs, LDTs are often used for rare conditions, novel diseases, or specialized testing not available through commercial kits. They are regulated primarily by the laboratory’s local and federal oversight, such as the Clinical Laboratory Improvement Amendments (CLIA), ensuring they meet quality standards. LDTs allow for rapid adaptation to emerging health issues and personalized medicine but require rigorous validation to ensure accurate and reliable results.