Companion_diagnostic
Companion diagnostic
Therapeutic drug diagnostic test
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]
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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]