Laboratory developed test

A Laboratory developed test (LDT) (pronunciation: /ˈlæbərəˌtɔri dɪˈvɛləpt tɛst/) is a type of clinical test that is designed, manufactured, and used within a single laboratory.

Etymology

The term "Laboratory developed test" is derived from the fact that these tests are not commercially manufactured, but rather developed and used by individual laboratories.

Definition

Laboratory developed tests are a subset of in vitro diagnostics (IVDs). Unlike traditional IVDs that are manufactured and sold to laboratories, hospitals, or physicians for use in testing patient samples, LDTs are both manufactured and used within a single laboratory. They are often used for rare conditions or in situations where no commercial test exists.

Regulation

In the United States, LDTs are regulated by the Food and Drug Administration (FDA). However, the FDA has historically exercised enforcement discretion, meaning it does not actively regulate most LDTs. This has led to a complex regulatory landscape for these tests.

Related Terms

In vitro diagnostics (IVDs): Tests done on samples such as blood or tissue that have been taken from the human body.
Clinical laboratory: A healthcare facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
Food and Drug Administration (FDA): A federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

External links

Medical encyclopedia article on Laboratory developed test
Wikipedia's article - Laboratory developed test

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Laboratory developed test