What is a Laboratory Developed Test (LDT)?

A Laboratory Developed Test (LDT) is a clinical test that is designed, developed, validated, and performed within a single CLIA-certified laboratory — rather than manufactured by an in vitro diagnostic (IVD) company and sold as a kit to multiple laboratories. LDTs are the standard pathway for many innovative, complex clinical tests that are developed in-house by academic medical centers, reference laboratories, and specialized clinical laboratories. Examples of widely used LDTs include many cancer gene sequencing panels, rare disease molecular tests, and numerous specialty assays. Under current federal regulation (42 U.S.C. § 263a), CLIA-certified laboratories are responsible for validating their own LDTs and maintaining the quality standards required by federal law. FDA pre-market approval is not currently required for most LDTs.