Abstract
Several drugs in late preclinical and early clinical development are now being targeted to disease-specific gene and protein biomarkers that may require co-approval of diagnostic and therapeutic products by regulatory agencies. An increasingly educated public is demanding more information about their predisposition for serious diseases and how these potential illnesses can be detected in an early stage when they can be arrested or cured with new therapies custom-designed for their individual clinical status. To respond to this demand, major pharmaceutical companies have partnered with clinical diagnostics companies or developed their own in-house capabilities to enhance efficiency and their ability to produce more effective and less toxic integrated personalized medicine ‘drug and test’ products. For clinical diagnostic laboratories, this integration of diagnostics and therapeutics represents a major new opportunity to emerge as leaders of the new medicine guiding the selection, dosage, route of administration and multi-drug combinations and producing increased efficacy and reduced toxicity of pharmaceutical products.