Companion diagnostics | 合法醫療器材資訊網

,2021年9月2日—Acompaniondiagnosticdevicecanbeinvitrodiagnosticdeviceoranimagingtoolthatprovidesinformationthatisessentialforthesafe ...,2013年3月27日—它是一種用於輔助醫師做出治療決策的檢驗方法，以決定對特定病人採用何種的治療方式。這種檢驗方法可藉由分析病人身上特定的生物標記（biomarker），來 ...,Acompaniondiagnostic(CDx)isadiagnostictestusedasacompaniontoatherapeuticdrugtodetermineitsapplicabilitytoaspecificperson.,Acompaniondiagnostic,orCDx,informstheuseofpersonalizedtreatmentoptionsforadvan...

Companion Diagnostics | 合法醫療器材資訊網

List of Cleared or Approved Companion Diagnostic Devices ... | 合法醫療器材資訊網

2021年9月2日 — A companion diagnostic device can be in vitro diagnostic device or an imaging tool that provides information that is essential for the safe ... Read More

什麼是CDx (Companion Diagnostics；搭配診斷試劑) | 合法醫療器材資訊網

2013年3月27日 — 它是一種用於輔助醫師做出治療決策的檢驗方法，以決定對特定病人採用何種的治療方式。這種檢驗方法可藉由分析病人身上特定的生物標記（biomarker），來 ... Read More

Companion diagnostic | 合法醫療器材資訊網

A companion diagnostic (CDx) is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. Read More

Their Critical Role in Cancer Care and Our Latest Approvals | 合法醫療器材資訊網

A companion diagnostic, or CDx, informs the use of personalized treatment options for advanced cancer patients by identifying FDA-approved treatment options ... Read More

Companion diagnostics (CDx) | 合法醫療器材資訊網

A companion diagnostic (CDx) is a medical device or test, which provides information that is essential for the safe and effective use of a particular ... Read More

FDA approved companion diagnostics | 合法醫療器材資訊網

由 JT Jørgensen 著作 · 2021 · 被引用 5 次 — FDA approved companion diagnostics ... In 2014, the FDA issued a regulatory guidance document on CDx, which defines this type of assay as an in vitro diagnostic ... Read More

companion diagnostic test | 合法醫療器材資訊網

A test used to help match a patient to a specific drug or therapy. For example, a companion diagnostic test may identify whether a patient's tumor has a ... Read More

Companion Diagnostics – Hematology & Oncology | 合法醫療器材資訊網

A companion diagnostic is required as a condition of use in order to make a medical product safe and effective. A companion diagnostic is therefore a subset of ... Read More

Companion diagnostics | 合法醫療器材資訊網

14 results — The global partner of choice for companion diagnostics, we help to advance Personalized Healthcare by delivering diagnostic confidence through a ... Read More

相關資訊整理