Using companion and coupled diagnostics within strategy to personalize targeted medicines

Abstract

Regulatory authorities expect the pharmaceutical and biotechnology industries to accelerate their development of companion diagnostics and companion therapeutics towards the goal of personalized medicine, and expect health services to fund, prescribers to adopt and patients to accept these new therapeutic technologies. Expected benefits from more systematic development of combination products (companion diagnostic and its companion therapeutic) are expected to include safer and improved clinical and cost-effective use of medicines, more efficient patient selection for clinical trials, more cost-effective treatment pathways for health services, and a more profitable approach for drug developers. This review discusses challenges to timely development of companion diagnostics and provides case studies of single and multiple protein and genetic biomarkers of clinical response and risk of adverse drug effects.