A medical device, frequently an in vitro device, is a companion diagnostic. It offers information necessary for the safe and efficient use of a matching medicine or biological product. The test aids a medical expert in determining whether the advantages to patients of a specific medicinal product will outweigh any potential serious dangers or side effects.
Companion diagnostics can:
• Identification of patients most likely to benefit from a specific medicinal product is possible with the use of companion diagnostics.
• Determine which people are more likely to experience major side effects from a specific medicinal substance; or
• Track patient response to a specific medicinal product in order to modify the course of treatment for increased safety or efficacy.
