CoDx definition
CoDx means an IVD whose use is necessary to safe and effective prescription, administration or dosing of a specific drug, such as without limitation by performing any or all of the following functions, (a) stratifying a group of patients so that those who would likely respond to the specific drug are identified, or (b) stratifying a group of patients so that those who would likely not respond to, or would be contraindicated for treatment with, the specific drug are identified.