Companion diagnostics (CDx)

Targos involvement during companion diagnostic (CDx) development

Companion diagnostics (CDx) have emerged as a critical tool for  the identification of patient sub-groups for personalized drug treatment. In conjunction with targeted drug development, CDx offer companies greater efficacy, accelerated regulatory approval and better reimbursement.

CDx have become an integral part of the clinical development process. When data on the predictive value of a biomarker are available, a drug cannot be approved without CDx. The example of Trastuzumab  (Herceptin®) from Roche and the corresponding companion diagnostic HercepTest™ from Dako for the treatment of breast and stomach cancer were the first examples to demonstrate the predictive power of CDx in targeted patient treatment.

CDx development is a complex process. It involves an understanding of  pharmaceutical company resources; diagnostic company goals; FDA regulatory requirements; clinical trial processes and the clinical goals of physicians amongst others.

Targos has the experience in all the above processes. Since its inception in 2005, the company has successfully supported more than 400 clinical trials and the successful approval of several targeted therapies and in CDx for our customers (see graphic). In addition, Targos has also introduced predictive biomarkers into the worldwide market by offering proficiency/reference testing and expert biomarker training courses.