{"entity":{"id":"arup-kit-d816v","kind":"drug","name":"KIT D816V Assay (ARUP Laboratories)","aka":["KIT D816V Assay"],"tldr":"The bone marrow test the FDA lists with imatinib for aggressive systemic mastocytosis, approved as a humanitarian device for a rare disease.","summary":"ARUP Laboratories' KIT D816V Assay was approved on 18 December 2015 under a Humanitarian Device Exemption (H140006), the route for devices used in rare conditions, and is listed by the FDA as the companion diagnostic for imatinib in aggressive systemic mastocytosis, tested on bone marrow.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA HDE H140006","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H140006"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["kit-d816v"],"cancers":["systemic-mastocytosis"],"sections":[],"technologies":["companion-diagnostic"],"targets":["kit"],"drugs":["imatinib"],"companies":["arup-laboratories"],"institutions":[],"pathways":[],"terms":["companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"KIT D816V Assay","modality":"KIT D816V mutation detection test (bone marrow), Humanitarian Device Exemption","mechanism":"Detects the KIT D816V mutation in bone marrow.","approvals":[{"region":"US","year":2015,"indication":"Humanitarian Device Exemption; companion to imatinib in aggressive systemic mastocytosis (bone marrow)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/arup-kit-d816v/","neighbours":{"biomarker":[{"id":"kit-d816v","kind":"biomarker","name":"KIT D816V","route":"/biomarkers/kit-d816v/"}],"cancer":[{"id":"systemic-mastocytosis","kind":"cancer","name":"Systemic mastocytosis","route":"/cancers/systemic-mastocytosis/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"kit","kind":"target","name":"KIT","route":"/targets/kit/"}],"drug":[{"id":"imatinib","kind":"drug","name":"Imatinib","route":"/drugs/imatinib/"}],"company":[{"id":"arup-laboratories","kind":"company","name":"ARUP Laboratories","route":"/companies/arup-laboratories/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"}]}}