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LDT

Meaning

LDT stands for Laboratory Developed Test, which is an in vitro diagnostic test that is designed, manufactured, and used entirely within a single laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in the United States. These tests are often customized assays used for specific or rare conditions, including highly specialized hormonal metabolite analysis or complex genetic panels that are not commercially available as FDA-approved kits. LDTs play a critical role in personalized medicine, offering rapid adaptation to emerging biomarkers and clinical needs in the hormonal health space. The regulation of LDTs is currently evolving, making it a complex area of clinical practice.