{"ok":true,"entity":{"id":"companion-diagnostic","name":"Companion diagnostic","entityType":"concept","officialName":"Companion diagnostic (CDx)","canonicalName":"Companion diagnostic","displayName":"Companion diagnostic","category":"医療機器・体外診断の規制上の概念","shortDescription":"コンパニオン診断（Companion diagnostic）は、対応する医薬品・生物学的製剤を安全かつ有効に使うために不可欠な情報を提供する医療機器（多くは体外診断用機器）を指す規制上の概念です。FDAは2014年8月にこの機器に関するガイダンスを発行し、EUではIVDR第2条(7)で定義され、少なくともクラスCに分類されるとBfArMのページに記載されています。","primaryCluster":"medical-device","parentEntity":null,"verificationStatus":"draft","website":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics","updatedAt":"2026-10-29T06:43:11.718Z","secondaryClusters":[],"alias":["コンパニオン診断","コンパニオン診断薬"],"searchKeywords":["コンパニオン診断","コンパニオン診断薬","companion diagnostic","CDx","体外診断","IVDR","FDA承認コンパニオン診断","バイオマーカー検査","個別化医療","in vitro companion diagnostic device"]},"referenceIndex":["P-01-001","P-02-001","P-04-001","P-05-001","P-06-001"]}