Laboratory-developed test

Laboratory-developed tests (LDTs) are a class of in vitro diagnostics (IVDs) designed, manufactured, and used within a single laboratory. They are employed for various medical diagnoses and research applications, offering advantages in flexibility and fostering innovation in the diagnostics field.

"Laboratory-developed test" is a term used to refer to a certain class of in vitro diagnostics (IVDs) that, in the U.S., were traditionally regulated under the Clinical Laboratory Improvement Amendments program.

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