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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]
 | This article may require cleanup to meet Wikipedia's quality standards. The specific problem is: lack of clarity, lots of repetitions and little real information. (June 2016) |
| 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]
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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.[7]
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