ABSTRACT

Incredibly high failure rate in the pharmaceutical industry has been positioning biomarkers and personalized medicine—with its prerequisite drug-diagnostic codevelopment, commonly known as companion diagnostics (CDx)—in the frontline as optimistic rescuers. This hopefulness is potentiated with the recent major advances and competitiveness in molecular diagnostics, which made the laboratory tests widely accessible at affordable prices. If executed right, biomarkers and CDx can potentially help drug industry enhancing the probability of success and, maybe, accelerating time to market; help the diagnostics industry developing tests utilizing precious, clinically annotated, human samples; and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most efficacious and least toxic therapies.