Laboratory Developed Tests (LDTs)

This information is meant to be used for educational purposes to inform providers, patients, and genetic service delivery stakeholders about genetics policy topics. Sharing of information, resources, or policy statements is no way an endorsement of stated positions by NCC.

Introduction

A laboratory-developed test (LDT) is a test that is designed, manufactured, and used within a single laboratory for clinical use. Most LDTs are not genetic tests; however, some genetic tests are LDTs. LDTs do not need to undergo pre-market review by the FDA.

In 2010, the FDA announced that it was reconsidering its policy concerning LDTs. They held a workshop to get input from stakeholders. A draft guidance was published in 2014. In 2017, the FDA issued a discussion paper on LDTs. However, that paper didn’t represent a formal position of the FDA, nor was it enforceable. The discussion of regulating LDTs is still ongoing. For more information, please visit the FDA website.

Legislation and Regulation

Genetic tests are regulated at a federal level by the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Federal Trade Commission (FTC). For more information on how tests can be evaluated, review the National Human Genome Research Institute (NHGRI) website page about genetic testing. Summaries of regulation of LDTs has been reviewed by the FDA.

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Policy Positions