# OnCo record fda-ldt-rule (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/fda-ldt-rule/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "fda-ldt-rule" ;
  schema:name "FDA laboratory-developed test (LDT) rule"@en ;
  schema:description "Most cancer tests in the US, including Galleri, Signatera and Oncotype DX, are 'lab-developed tests' overseen through lab standards rather than FDA approval; the FDA's 2024 attempt to change that was struck down in court in 2025."@en ;
  schema:url <https://onco.cc/terms/fda-ldt-rule/> ;
  schema:dateModified "2026-09-10"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Laboratory-developed_test> ;
  schema:citation <https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests> ;
  onco:technologies <https://onco.cc/technologies/companion-diagnostic/>, <https://onco.cc/technologies/mrd-testing/>, <https://onco.cc/technologies/mced/> ;
  onco:drugs <https://onco.cc/drugs/galleri/>, <https://onco.cc/drugs/signatera/>, <https://onco.cc/drugs/cancerguard/> ;
  onco:terms <https://onco.cc/terms/ivdr/>, <https://onco.cc/terms/regulatory-agencies/> .