Companion diagnostic

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Companion diagnostic
Purposeto determine the correct therapeutic agent for an individual

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 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]


In 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.[citation needed]

See also


  1. ^ "Pfizer Taps Foundation Medicine for CDx Development". Clinical OMICs. 16 January 2018. Retrieved 19 January 2018.
  2. ^ "Companion Diagnostics" (Page Last Updated 07/14/2016). FDA. Retrieved 26 September 2016.
  3. ^ 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.
  4. ^ Kim, Il-Jin (2019-03-06). Companion Diagnostics (CDx) in Precision Medicine. CRC Press. ISBN 978-1-000-00721-3.
  5. ^ 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.
  6. ^ "List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)". United States Food and Drug Administration (FDA). 2023-05-09.


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