Laboratory-developed tests

Laboratory-developed tests (LDTs) are medical tests created and used by a healthcare laboratory, rather than being commercially sold by a third-party company. These tests are designed locally to diagnose, monitor, or predict health conditions. They are often developed to address specific medical needs or rare diseases that standard tests may not cover. While they undergo validation within the laboratory to ensure accuracy and reliability, they are generally not subject to the same regulatory approval process as commercially available tests. LDTs play a crucial role in personalized medicine and specialized diagnostics.