All terms
Laboratory-Developed Test
IVD designed, manufactured, and used within a single CLIA laboratory.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
LDTs are diagnostic tests developed and performed by a single high-complexity CLIA-certified laboratory rather than distributed as kits. FDA historically exercised enforcement discretion; a 2024 final rule began phasing in active oversight.What this means in practice
Many oncology, infectious disease, and rare-disease tests reached patients as LDTs. The FDA LDT rule, ongoing litigation, and CMS PAMA repricing are key uncertainties.Cross-references
Governed by
Regulations or standards this term must comply with.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
FDA·1AdvaMed·1MedTech Europe·1
- 1
FDA LDT final ruleVerifiedFDAfda.gov
- 2
AdvaMed - Industry ReportsVerifiedAdvaMedadvamed.org
- 3
MedTech Europe - Facts & FiguresVerifiedMedTech Europemedtecheurope.org
Inline markers like [1] jump to the matching reference above.