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A companion diagnostic (CDx)[1] is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person.[2]
| Companion diagnostic | |
|---|---|
| Purpose | to determine the correct therapeutic agent for an individual |
Companion diagnostics are co-developed with drugs to aid in selecting or excluding patient groups for treatment with that particular drug based on their biological characteristics that determine responders and non-responders to the therapy.[3][4]
Companion diagnostics are developed based on companion biomarkers, biomarkers that prospectively help predict likely response or severe toxicity.[5]
For example, there is an automatic immunohistochemistry staining machine for microscopy slides to highlight HER2 expression. This machine is classified by the U.S. Food and Drug Administration (FDA) as a companion diagnostic device for the drug trastuzumab which works on tumors that over-express HER2.[6]
EU IVDR
editIn Europe the regulation on in vitro diagnostics (IVDR) defines companion diagnostics as devices that are essential for the safe and effective use of corresponding medicinal products to identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or to identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal products.[7]
See also
editReferences
edit- ^ "Pfizer Taps Foundation Medicine for CDx Development". Clinical OMICs. 16 January 2018. Retrieved 19 January 2018.
- ^ "Companion Diagnostics" (Page Last Updated 07/14/2016). FDA. Retrieved 26 September 2016.
- ^ Trusheim, MR; Burgess, B; Hu, SX; Long, T; Averbuch, SD; Flynn, AA; Lieftucht, A; Mazumder, A; Milloy, J; Shaw, PM; Swank, D; Wang, J; Berndt, ER; Goodsaid, F; Palmer, MC (31 October 2011). "Quantifying factors for the success of stratified medicine". Nature Reviews. Drug Discovery. 10 (11): 817–833. doi:10.1038/nrd3557. PMID 22037040. S2CID 2079294.
- ^ Kim, Il-Jin (2019-03-06). Companion Diagnostics (CDx) in Precision Medicine. CRC Press. ISBN 978-1-000-00721-3.
- ^ Duffy, MJ; Crown, J (October 2013). "Companion biomarkers: paving the pathway to personalized treatment for cancer". Clinical Chemistry. 59 (10): 1447–1456. doi:10.1373/clinchem.2012.200477. PMID 23656699.
- ^ "List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)". United States Food and Drug Administration (FDA). 2023-05-09.
- ^ (Article 2, 7 Regulation (EU) 2017/746):