Companion Diagnostics

Complementary Diagnostics

Information is ESSENTIAL for the safe and effective use of a corresponding therapeutic product Complementary diagnostics are NOT ESSENTIAL for the safe and effective use of a corresponding therapeutic product
Associated drug is demonstrated to be safe and effective only for patients with a specific test result Associated drug is safe and effective for the unstratified studied population
Included as a part of the associated drug’s Indication for use Complementary diagnostics may be mentioned in the clinical studies or other drug label sections but would not be a part of a drug’s Indication for Use section
Test provides additional information about how a specific drug might be used, or guide use of a class of drugs Intended only to determine if the associated drug will be safe and effective for the patient
An FDA regulated product