Companion Diagnostic Immunoassays

A companion diagnostic is a medical device which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks. This could be by identifying patients who are most likely to benefit from a particular therapeutic product; identifying patients likely to be at increased risk for serious side effects; or monitoring response to treatment. If the diagnostic test is inaccurate, then the treatment decisions based on its data may not be optimal.