# OnCo record arup-kit-d816v (drug). 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/drugs/arup-kit-d816v/>
  a schema:MedicalDevice ;
  onco:kind "drug" ;
  schema:identifier "arup-kit-d816v" ;
  schema:name "KIT D816V Assay (ARUP Laboratories)"@en ;
  schema:alternateName "KIT D816V Assay"@en, "KIT D816V Assay" ;
  schema:description "The bone marrow test the FDA lists with imatinib for aggressive systemic mastocytosis, approved as a humanitarian device for a rare disease."@en ;
  schema:url <https://onco.cc/drugs/arup-kit-d816v/> ;
  schema:dateModified "2026-11-03"^^xsd:date ;
  schema:citation <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H140006>, <https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools> ;
  onco:status "approved" ;
  onco:tag "test" ;
  onco:modality "KIT D816V mutation detection test (bone marrow), Humanitarian Device Exemption" ;
  onco:approval "US 2015: Humanitarian Device Exemption; companion to imatinib in aggressive systemic mastocytosis (bone marrow)" ;
  onco:related <https://onco.cc/biomarkers/kit-d816v/> ;
  onco:cancers <https://onco.cc/cancers/systemic-mastocytosis/> ;
  onco:technologies <https://onco.cc/technologies/companion-diagnostic/> ;
  onco:targets <https://onco.cc/targets/kit/> ;
  onco:drugs <https://onco.cc/drugs/imatinib/> ;
  onco:companies <https://onco.cc/companies/arup-laboratories/> ;
  onco:terms <https://onco.cc/terms/companion-diagnostic-term/> .