Laboratory Developed Tests Demonstration Project

New laboratory-developed tests (LDTs) used to diagnose and assess various conditions have been added to the list of LDTs covered under TRICARE’s LDT Demonstration. The LDTs covered under this demonstration have not yet been approved by the U.S. Food and Drug Administration (FDA). Examples of these tests include those used for rare and emergent diseases and disorders, such as Turcot syndrome or certain types of leukemia, and those used to determine matches for organ donation. Usually, LDTs are developed by hospital, academic and clinical laboratories to provide safe steps to follow when there is no FDA guidance. This demonstration project also covers BRCA1 and BRCA2 genetic counseling and testing, which is used to find breast cancer.