Companion Diagnostics and Beyond – An Essential Element in the Puzzle of Transforming Healthcare

The use of nucleic acid‐based diagnostic tests as guiding elements for a specific drug has become the essential element of companion diagnostics (CDx). This chapter shows the benefit of nucleic acid‐based CDx tests that result in improved medical outcome and at the same time in lower healthcare costs due to personalized targeted treatment. The CDx has an evolutionary continuance of in vitro diagnostic (IVD) tests with goal to ensure the optimal use of a drug as part of therapy. All drivers for the increase of use of CDx have their basis in the challenges pharma is facing. In summary, there are two key drivers. The first driver is based on increased hurdles by regulators for new drugs to make it to market and the second driver is that pharma companies are becoming financially strained.