A companion diagnostic is an assay that provides biological and/or clinical essential information that enables better decision making about the development and use of a potential drug therapy. They are used to monitor efficacy and/or safety following the patient’s response to a specific drug. This can be applied anywhere along the preclinical, clinical and post-product launch of the drug.
To date, many of the pharmaceutical companies have started their in house efforts and established biomarker groups or even diagnostic groups. The trend is to establish drug-companion diagnostic co-Development rather than have both developments happen in isolation.
Health authorities will prioritize the reimbursement of new targeted therapies that include predictive and monitoring tools which are sensitive and easy to use.